ArticleLiterature Review

Evidence-informed management of chronic low back pain with intradiscal electrothermal therapy

Authors:
  • Spinal Diagnostics and Treatment Center
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Abstract

The management of chronic low back pain (CLBP) has proven very challenging in North America, as evidenced by its mounting socioeconomic burden. Choosing among available nonsurgical therapies can be overwhelming for many stakeholders, including patients, health providers, policy makers, and third-party payers. Although all parties share a common goal and wish to use limited health-care resources to support interventions most likely to result in clinically meaningful improvements, there is often uncertainty about the most appropriate intervention for a particular patient. To help understand and evaluate the various commonly used nonsurgical approaches to CLBP, the North American Spine Society has sponsored this special focus issue of The Spine Journal, titled Evidence-Informed Management of Chronic Low Back Pain Without Surgery. Articles in this special focus issue were contributed by leading spine practitioners and researchers, who were invited to summarize the best available evidence for a particular intervention and encouraged to make this information accessible to nonexperts. Each of the articles contains five sections (description, theory, evidence of efficacy, harms, and summary) with common subheadings to facilitate comparison across the 24 different interventions profiled in this special focus issue, blending narrative and systematic review methodology as deemed appropriate by the authors. It is hoped that articles in this special focus issue will be informative and aid in decision making for the many stakeholders evaluating nonsurgical interventions for CLBP.

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... The rationale for heating intervertebral discs was strongly influenced by animal and clini cal investigations testing the ability of heat to stabilize joints by modifying collagen [39]. The goal of thermal disc treatment is to create a seal to limit the expression of matrix components, shrink collagen tissue and destroy nociceptors [39]. ...
... The rationale for heating intervertebral discs was strongly influenced by animal and clini cal investigations testing the ability of heat to stabilize joints by modifying collagen [39]. The goal of thermal disc treatment is to create a seal to limit the expression of matrix components, shrink collagen tissue and destroy nociceptors [39]. Intradiscal heating can be accomplished through a variety of means, including electro cautery, thermal cautery, laser and radiofre quency energy. ...
... However, Bass et al. showed that the annulus will only shrink 7.5% after being heated to 85°C com pared with 60-80% in the shoulder capsule [44]. They postulated that further shrinkage is likely retarded by the attachment of the annulus to the bony endplates [39]. By contrast, Cohen et al., in a retrospective series, reported new disc hernia tions in two out of 79 patients after IDET [46]. ...
Article
Full-text available
The intradiscal electrothermal therapy (IDET) procedure is a minimally invasive technique designed to treat discogenic chronic low back pain. The debate surrounding IDET ranges from the concept of the procedure, the technique and patient selection, to its effectiveness. The procedure provides modest improvement; however, it is considered less invasive and destructive than other modalities of treatments available at the present time, and has lower cost. The effectiveness evidence is limited at the present time, but based on the results of six recently published positive single-arm studies, it appears that patients experienced a perceptible clinical benefit from the IDET procedure. Thus, IDET is recommended in patients with moderate functional impairment, relatively well-maintained disc heights and discogenic pain caused by annular tears or protrusions less than 3-4 mm after the failure of less invasive procedures.
... Other invasive techniques have been utilized to target the DRG and adjacent nerves for the treatment of chronic pain. The most common of these treatment modalities involves the delivery of radiofrequency (RF) energy to the neural tissue within and adjacent to the DRG [39][40][41][42]. ...
... Several relatively recent reviews of the literature have been completed reviewing the clinical utility of RF based therapies targeting the DRG [40][41][42][43][44][45]. A literature review was conducted searching for papers specifically targeting the DRG utilizing either continuous RF or pulsed radiofrequency (PRF) techniques. ...
... A literature review was conducted searching for papers specifically targeting the DRG utilizing either continuous RF or pulsed radiofrequency (PRF) techniques. In total, 23 articles fit the search criterion of examining RF energy delivery to the DRG as a means of treatment for chronic pain (Table 2) [42,44,. From the available articles, a sum total of more than 1000 patients were treated with either PRF or continuous RF. ...
Conference Paper
Full-text available
Durable pain remission using radiofrequency thermal neurotomy (RTN) requires thoughtful patient selection and a lesion of optimal size and position. Success necessitates complete ablation of approximately 8-10 mm of the targeted neural pathway. Technical failure may result if anatomical variations in the targeted pathway are not incorporated into the lesion and if the electrode is not positioned optimally relative to the target nerve. This paper presents an improvement in RF electrode design intended to improve RTN outcomes. Keywords: radiofrequency thermal neurotomy, pain management
... nisms have been provided to explain why lumbar disc degeneration leads to pain, an attractive explanation is the growth of nerves capable of expressing pain deep into the annular structures. Granulation tissue is present in the same area as part of the healing process; this tissue contains a number of mediators, such as cytokines, prostaglandin E2, interleukin(IL)-6, and IL-8 which can sensitize the nociceptors, so that loading within a physiological range can lead to pain (38,39). The goal of the application of heat across the damaged annulus is to denervate the annulus, leading to pain relief (40). ...
... Both hypotheses have been criticized (42). Derby et al (39) have reviewed the proposed mechanisms of action and have concluded that the mechanism is unclear. ...
... Ackerman (120) and Hsia et al (121) have reported cauda equine syndrome. Derby et al (39) reported a review of 1,675 IDET procedures and 35,000 medical device reports from the Food and Drug Administration. There were 6 nerve root injuries, 5 of which were related to the placement of the introducer needle. ...
Article
Full-text available
Persistent low back pain refractory to conservative treatment is a common problem that leads to widespread impairment, resulting in significant costs to society. The intervertebral disc is a major source of persistent low back pain. Technologies developed to treat this problem, including various surgical instrumentation and fusion techniques, have not reliably provided satisfactory results in terms of either pain relief or increased function. Thermal annular procedures (TAPs) were first developed in the late 1990s in an attempt to treat discogenic pain. The hope was that they would provide greater value than fusion in terms of efficacy, morbidity, and cost. Three technologies have been developed to apply heat to the annulus: intradiscal electrothermal therapy (IDET), discTRODE, and biacuplasty. Since nerve ingrowth and tissue regeneration in the annulus is felt to be the source of pain in discogenic low back pain, when describing the 3 above techniques we use the term "thermal annular procedures" rather than "thermal intradiscal procedures." We have specifically excluded studies treating the nucleus. TAPs have been the subject of significant controversy. Multiple reviews have been conducted resulting in varying conclusions. A systematic review of TAPs for the treatment of discogenic low back pain. To evaluate the effectiveness of TAPs in treating discogenic low back pain and to assess complications associated with those procedures. The available literature on TAPs in treating discogenic low back pain was reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria for interventional techniques for randomized trials, and the criteria developed by the Newcastle-Ottawa Scale criteria for observational studies. The level of evidence was classified as good, fair, or poor based on the quality of evidence developed by the U.S. Preventive Services Task Force. Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 through December 2011, and manual searches of the bibliographies of known primary and review articles. The primary outcome measure was pain relief of at least 6 months. Secondary outcome measures were improvements in functional status. For this systematic review, 43 studies were identified. Of these, 3 randomized controlled trials and one observational study met the inclusion criteria. Using current criteria for successful outcomes, the evidence is fair for IDET and poor for discTRODE and biacuplasty procedures regarding whether they are effective in relieving discogenic low back pain. Since 2 randomized controlled trials are in progress on that procedure, assessment of biacuplasty may change upon publication of those studies. The limitations of this systematic review include the paucity of literature and non-availability of 2 randomized trials which are in progress for biacuplasty. In summary, the evidence is fair for IDET and poor for discTRODE and biacuplasty is being evaluated in 2 ongoing randomized controlled trials.
... nisms have been provided to explain why lumbar disc degeneration leads to pain, an attractive explanation is the growth of nerves capable of expressing pain deep into the annular structures. Granulation tissue is present in the same area as part of the healing process; this tissue contains a number of mediators, such as cytokines, prostaglandin E2, interleukin(IL)-6, and IL-8 which can sensitize the nociceptors, so that loading within a physiological range can lead to pain (38,39). The goal of the application of heat across the damaged annulus is to denervate the annulus, leading to pain relief (40). ...
... Both hypotheses have been criticized (42). Derby et al (39) have reviewed the proposed mechanisms of action and have concluded that the mechanism is unclear. ...
... Ackerman (120) and Hsia et al (121) have reported cauda equine syndrome. Derby et al (39) reported a review of 1,675 IDET procedures and 35,000 medical device reports from the Food and Drug Administration. There were 6 nerve root injuries, 5 of which were related to the placement of the introducer needle. ...
Article
Background: Persistent low back pain refractory to conservative treatment is a common problem that leads to widespread impairment, resulting in significant costs to society. The intervertebral disc is a major source of persistent low back pain. Technologies developed to treat this problem, including various surgical instrumentation and fusion techniques, have not reliably provided satisfactory results in terms of either pain relief or increased function. Thermal annular procedures (TAPs) were first developed in the late 1990s in an attempt to treat discogenic pain. The hope was that they would provide greater value than fusion in terms of efficacy, morbidity, and cost. Three technologies have been developed to apply heat to the annulus: intradiscal electrothermal therapy (IDET), discTRODE, and biacuplasty. Since nerve ingrowth and tissue regeneration in the annulus is felt to be the source of pain in discogenic low back pain, when describing the 3 above techniques we use the term “thermal annular procedures” rather than “thermal intradiscal procedures.” We have specifically excluded studies treating the nucleus. TAPs have been the subject of significant controversy. Multiple reviews have been conducted resulting in varying conclusions. Study Design: A systematic review of TAPs for the treatment of discogenic low back pain. Objective: To evaluate the effectiveness of TAPs in treating discogenic low back pain and to assess complications associated with those procedures. Methods: The available literature on TAPs in treating discogenic low back pain was reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria for interventional techniques for randomized trials, and the criteria developed by the Newcastle-Ottawa Scale criteria for observational studies. The level of evidence was classified as good, fair, or limited (or poor) based on the quality of evidence developed by the U.S. Preventive Services Task Force. Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 through December 2011, and manual searches of the bibliographies of known primary and review articles. Outcome Measures: The primary outcome measure was pain relief of at least 6 months. Secondary outcome measures were improvements in functional status. Results: For this systematic review, 43 studies were identified. Of these, 3 randomized controlled trials and one observational study met the inclusion criteria. Using current criteria for successful outcomes, the evidence is fair for IDET and limited (or poor) for discTRODE and biacuplasty procedures regarding whether they are effective in relieving discogenic low back pain. Since 2 randomized controlled trials are in progress on that procedure, assessment of biacuplasty may change upon publication of those studies. Limitations: The limitations of this systematic review include the paucity of literature and nonavailability of 2 randomized trials which are in progress for biacuplasty. Conclusion: In summary, the evidence is fair for IDET and limited (or poor) for discTRODE and biacuplasty is being evaluated in 2 ongoing randomized controlled trials. Key words: Spinal pain, chronic low back pain, discogenic pain, thermal procedures, annular procedures, IDET, biaculoplasty, disctrode
... Despite the ongoing clarification as to the mechanisms by which intradiscal pain occurs, the mechanisms by which heat relieves pain emanating from the disc are unclear. Derby et al (39) have reviewed the proposed mechanisms of action, including changes in disc biomechanics, annular contraction, thermally induced healing response, sealing of annular tears, annular denervation, and decreased intradiscal disorder, with the conclusion that the mechanism of pain relief is unclear. Derby et al (39) hypothesize that if patients with no or a minimal (< 1 week) flare of pain after the procedure do better, then that finding would be consistent with a denervation mechanism. ...
... Derby et al (39) have reviewed the proposed mechanisms of action, including changes in disc biomechanics, annular contraction, thermally induced healing response, sealing of annular tears, annular denervation, and decreased intradiscal disorder, with the conclusion that the mechanism of pain relief is unclear. Derby et al (39) hypothesize that if patients with no or a minimal (< 1 week) flare of pain after the procedure do better, then that finding would be consistent with a denervation mechanism. Kapural et al (40) have shown that intradiscal biacuplasty (IDB) generates sufficient annular temperatures for neuroablation, suggesting that the pain relief is caused by denervation. ...
Article
Full-text available
Chronic discogenic low back pain is a common problem with significant personal and societal costs. Thermal annular procedures (TAPs) have been developed in an effort to provide a minimally invasive treatment for this disorder. Multiple techniques utilized are intradiscal electrothermal therapy (IDET), radiofrequency annuloplasty, and intradiscal biacuplasty (IDB). However, these treatments continue to be controversial, coupled with a paucity of evidence. A systematic review of the literature evaluating the efficacy or effectiveness of TAPs. To determine the effectiveness of TAPs in reducing low back pain in patients with intradiscal disorders. A comprehensive evaluation of the literature relating to TAPs was performed. The literature was evaluated according to Cochrane Review criteria for randomized controlled trials (RCTs) and according to the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies. The level of evidence was classified as Level I, II, or III based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Pain relief was the primary outcome measure. Other outcome measures were functional improvement, improvement of psychological status, and return to work. Data sources included relevant literature of the English language identified through searches of PubMed, EMBASE, the Cochrane Library, and the Database of Reviews of Effectiveness (DARE). Short-term effectiveness was defined as one-year or less and long-term effectiveness was defined as greater than one-year. Systematic review of IDET identified 2 RCTs and 16 observational studies with an indicated evidence of Level II-2. Systematic review of radiofrequency annuloplasty identified no RCTs but 2 observational studies with an uncertain evidence of Level II-3. Systematic review of IDB identified one pilot study. The level of evidence is lacking with Level III. The limitations of this review include paucity of the literature and lack of evidence with internal validity and generalizability. IDET offers functionally significant relief in approximately one-half of appropriately chosen chronic discogenic low back pain patients. There is minimal evidence supporting the use of radiofrequency annuloplasty and IDB.
... Despite the ongoing clarification as to the mechanisms by which intradiscal pain occurs, the mechanisms by which heat relieves pain emanating from the disc are unclear. Derby et al (39) have reviewed the proposed mechanisms of action, including changes in disc biomechanics, annular contraction, thermally induced healing response, sealing of annular tears, annular denervation, and decreased intradiscal disorder, with the conclusion that the mechanism of pain relief is unclear. Derby et al (39) hypothesize that if patients with no or a minimal (< 1 week) flare of pain after the procedure do better, then that finding would be consistent with a denervation mechanism. ...
... Derby et al (39) have reviewed the proposed mechanisms of action, including changes in disc biomechanics, annular contraction, thermally induced healing response, sealing of annular tears, annular denervation, and decreased intradiscal disorder, with the conclusion that the mechanism of pain relief is unclear. Derby et al (39) hypothesize that if patients with no or a minimal (< 1 week) flare of pain after the procedure do better, then that finding would be consistent with a denervation mechanism. Kapural et al (40) have shown that intradiscal biacuplasty (IDB) generates sufficient annular temperatures for neuroablation, suggesting that the pain relief is caused by denervation. ...
Article
Background: Chronic discogenic low back pain is a common problem with significant personal and societal costs. Thermal annular procedures (TAPs) have been developed in an effort to provide a minimally invasive treatment for this disorder. Multiple techniques utilized are intradiscal electrothermal therapy (IDET), radiofrequency annuloplasty, and intradiscal biacuplasty (IDB). However, these treatments continue to be controversial, coupled with a paucity of evidence. Study Design: A systematic review of the literature evaluating the efficacy or effectiveness of TAPs. Objective: To determine the effectiveness of TAPs in reducing low back pain in patients with intradiscal disorders. Methods: A comprehensive evaluation of the literature relating to TAPs was performed. The literature was evaluated according to Cochrane Review criteria for randomized controlled trials (RCTs) and according to the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies. The level of evidence was classified as Level I, II, or III based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Pain relief was the primary outcome measure. Other outcome measures were functional improvement, improvement of psychological status, and return to work. Data sources included relevant literature of the English language identified through searches of PubMed, EMBASE, the Cochrane Library, and the Database of Reviews of Effectiveness (DARE). Outcome Measures: Short-term effectiveness was defined as one-year or less and long-term effectiveness was defined as greater than one-year. Results: Systematic review of IDET identified 2 RCTs and 16 observational studies with an indicated evidence of Level II-2. Systematic review of radiofrequency annuloplasty identified no RCTs but 2 observational studies with an uncertain evidence of Level II-3. Systematic review of IDB identified one pilot study. The level of evidence is lacking with Level III. Limitations: The limitations of this review include paucity of the literature and lack of evidence with internal validity and generalizability. Conclusion: IDET offers functionally significant relief in approximately one-half of appropriately chosen chronic discogenic low back pain patients. There is minimal evidence supporting the use of radiofrequency annuloplasty and IDB. Key words: Chronic low back pain, degenerative disc disease, internal disc disruption, intervertebral disc, thermal annular procedures, intradiscal electrothermal therapy, radiofrequency ablation, intradiscal biacuplasty, radiofrequency annuloplasty
... [42,43] Temperature is thought to cause local denaturation of collagen fibrils, cauterization of granulation tissue, and coagulation of nerve fibers. [44][45][46] Favorable outcomes in pain and disability can be achieved, when patients are selected correctly [42,43] [ Table 1]. ...
... [108] In addition, the North American Spine Society suggests that for less disabled patients with annular tears or protrusions <3 mm-4 mm and relatively well-preserved disc heights, IDET would seem to be a reasonable primary option treatment. [44] In contrast to IDET, there is far less literature on RFA and IDB procedures. There are little data on the effectiveness of RFA and IDB, and according to Helm et al., [6] the evidence is limited for both procedures regarding whether they are effective in relieving discogenic CLBP. ...
Article
Full-text available
Study design: A systemic review of thermal annular procedures (TAPs) and percutaneous disk decompression procedures (PDDPs) for the treatment of discogenic chronic low back pain (CLBP) was conducted. Objective: The objective of this review is to evaluate and to compare the effectiveness of TAPs and PDDPs in treating discogenic CLBP and to assess the frequency of complications associated with those procedures. Materials and methods: English-language journal articles were identified through computerized searches of the PubMed database and bibliographies of identified articles and review papers. Articles were selected for inclusion if percutaneous minimally invasive procedures were the treatment options for patients with CLBP and if follow-up outcome data included evaluations of back pain severity, functional improvement, and/or incidence of complications. For this review, 27 studies were included. Results: Intradiscal electrothermal therapy (IDET) procedure in properly selected patients may eliminate or delay the need for surgical intervention for an extended period, whereas few adverse effects have been reported. In contrast to IDET, there is far less literature on the effectiveness of radiofrequency annuloplasty and intradiscal biacuplasty procedures. Nucleoplasty is a potentially effective treatment option for patients with contained disc herniation, while the procedure is well tolerated. Increased success rates have been found for percutaneous laser disc decompression and automated percutaneous lumbar discectomy in strictly selected patients. Conclusions: These procedures can be effective and may obviate the need for surgery completely. Further prospective randomized sham-controlled trials with higher quality of evidence are necessary to confirm the efficacy of these procedures.
... The use of heat energy to treat chronic low back pain (CLBP) is an alternative to standard surgical procedures in certain patients. Reviews on the efficacy of this technique found that it provides only modest improvement, but is likely to be a less destructive, cheaper and safer method than other invasive therapies (Derby et al, 2008) with better prospects for pain relief than improved functionality. ...
... The role of adjunctive analgesics in the relief of chronic back pain has grown in recent years as the traditional analgesics have not always managed to bring relief to chronic sufferers. These medications include tricyclic antidepressants, selective serotoninnorepinephrine reuptake inhibitors and antiepileptic drugs and can be prescribed by general practitioners (Chang et al, 2008). ...
Thesis
Full-text available
Back pain is a major health problem in the Western World impacting on individuals, their families and the whole society. Back pain causes significant economic costs due to health expenses and absenteeism from work. Most cases of back pain respond well to treatments and are resolved within weeks. However, some individuals do not respond well to medical treatments and experience persistent back pain that becomes chronic in nature. Chronic back pain is characterised by its duration and its poor response to medical interventions. The literature researched indicated that in most cases the experience of chronic back pain is heavily influenced by psychosocial factors, which impact on individuals more than the original injury or disease. There is limited literature in relation to biopsychosocial factors and treatment up-take. The aim of this study was to explore the impact of biopsychosocial factors in the experience of chronic back pain. It was hypothesised that biopsychosocial factors would have an impact on the number of treatments received and the level of disability reported. A total of 201 adult participants (men and women) completed a battery of questionnaires that collected demographic information, psychological distress, social support, pain levels and disability scores. The findings indicated that psychosocial factors had a greater impact on the number of treatment sessions and reported disability than level and/or duration of pain. Education level was the strongest marker for both hypotheses with tertiary educated participants reporting significantly higher numbers of treatment sessions and lower disability scores. The findings of this study supported the Biopsychosocial Model of Health and the Theory of Social Causation. In addition, the findings supported previous research that advocated that a diagnosis of chronic back pain is a unique condition different from acute or temporary pain. Furthermore, the findings supported the creation of new diagnostic and measurement tools for chronic back that include psychological and social measures in addition to biological indicators. Finally, the findings offered renewed backing for interdisciplinary approaches to the treatment of chronic back pain in light to its multifaceted nature.
... Cauda equina syndrome has also been reported (91)(92)(93). Derby et al (94) reported a review of 1,675 IDET procedures and 35,000 medical device reports from the Food and Drug Administration. There were 6 nerve root injuries, 5 of which were related to the placement of the introducer needle. ...
Article
Background: Discogenic low back is a distinct clinic entity characterized by pain arising from a damaged disc. The diagnosis is clouded by the controversy surrounding discography. The treatment options are limited, with unsatisfactory results from both conservative treatment and surgery. Multiple interventional therapies have been developed to treat discogenic pain, but most have not yet been validated by high quality studies.The best studied treatment for discogenic pain is the use of heat, which has been labeled as thermal intradiscal procedures (TIPs) by the Centers for Medicare and Medicaid Services (CMS). As the pathology is located in the annulus, we use the term thermal annular procedures (TAPs). Objectives: The aim of this study is to evaluate and update the efficacy of TAPs to treat chronic refractory discogenic pain. Study design: The design of this study is a systematic review. Methods: The available literature on TAPs in treating chronic refractory discogenic pain was reviewed. The quality of each article used in this analysis was assessed.The level of evidence was classified on a 5-point scale from strong, based upon multiple randomized controlled trials (RCTs) to weak, based upon consensus, as developed by the US Preventive Services Task Force (USPSTF) and modified by the American Society of Interventional Pain Physicians (ASIPP).Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to September 2015 and manual searches of the bibliographies of known primary and review articles.The primary outcome measures were pain relief and functional improvement of at least 40%. Short-term efficacy was defined as improvement for less than 6 months; long-term efficacy was defined as improvement for 6 months or more. Results: For this systematic review, 49 studies were identified. Of these, there were 4 RCTs and no observational studies which met the inclusion criteria. Based upon 2 RCTs showing efficacy, with no negative trials, there is Level I, or strong, evidence of the efficacy of biacuplasty in the treatment of chronic, refractory discogenic pain.Based upon one high-quality RCT showing efficacy and one moderate-quality RCT interpreted as showing no benefit, there is Level III, or moderate, evidence supporting the use of intradiscal electrothermal therapy (IDET) in treating chronic, refractory discogenic pain.The evidence supporting the use of discTRODE is level V, or limited. Conclusion: The evidence is Level I, or strong, that percutaneous biacuplasty is efficacious in the treatment of chronic, refractory discogenic pain. Biacuplasty may be considered as a first-line treatment for chronic, refractory discogenic pain.The evidence is Level III, or moderate, that IDET is efficacious in the treatment of chronic, refractory discogenic pain.The evidence is Level V, or limited, that discTRODE is efficacious in the treatment of chronic, refractory discogenic pain.Key words: Spinal pain, chronic low back pain, intradiscal disorder, IDET, biacuplasty, discTRODE, thermal intradiscal disorders, thermal annular disorders.
... mean ODI treatment success scores were 56.52±5.32 and 61.80±9.40. In DDS3-4-5 patients, mean ation of collagen fibers, cauterization of granulation tissue, and coagulation of nerve fibers (5,8,26,28). IDET produced sufficient temperatures to induce collagen denaturation and coalescence in human cadaveric lumbar discs (31). ...
Article
Full-text available
Aim: Intervertebral disc degeneration can cause severe low back pain. Intradiscal electrothermal therapy (IDET) is a minimally invasive treatment option for patients with symptomatic internal disc disruption unresponsive to conservative medical care. We aimed to evaluate 12-month pain and functional outcomes and predictors of clinical success in patients with discogenic back pain treated with IDET with respect to the Dallas Discogram Scale (DDS). Material and methods: This was a retrospective analysis of patients undergoing IDET for low back pain from 2009 through 2014 at Baskent University department of Neurosurgery. A total 120 consecutive patients data were collected retrospectively. The degree of disc degeneration was graded using the DDS during discography, and the presence of a high intensity zone (HIZ) on magnetic resonance (MR) imaging was noted. The primary outcome measure was assessment of back pain severity based on the Visual Analogue Scale (VAS); function was assessed by the Oswestry Disability Index (ODI). Follow-up examinations for ODI and VAS scores were assessed at 1, 6, and 12 months post-treatment. Outcomes were discussed with respect to morphological changes in intervertebral discs on discogram. Results: There was an average 57.39 % and 47.16 % improvement in VAS and ODI scores, respectively, between pretreatment and 12 months follow-up (p 0.0001 for both comparisons). Predictors of 12 month clinical success was depended on DDS (p 0.0001), a HIZ on MR imaging (p 0.0001). Conclusion: Durable clinical improvements can be realized after IDET in select surgical candidates with mild disc degeneration and HIZ, discography, and low-grade DDS, with more effective treatment results.
... It involves inserting a navigable electrothermal catheter to the inner posterior annulus and delivering heat that aims at inducing retraction of the annular collagen, therefore coagulating inflammatory tissue and nerve endings in the periphery of the disc posteriorly (Saal and Saal, 2000). Although somewhat difficult to achieve, placement of the electrothermal catheter should aim to allow for the active portion of the catheter to provide sufficient heat to spread to both the outer and inner annulus (Karasek and Bogduk, 2000; Derby et al., 2008). Examples of indications for IDET include severe chronic low back pain for greater than 3 months, persistent pain after at least 3 months of aggressive conservative treatment, normal neurological examination, less than 30% collapse of the disc space, and no measureable segmental instability (e.g., spondylolisthesis) (Saal and Saal, 2004). ...
Article
Full-text available
Chronic low back pain attributed to lumbar disc degeneration poses a serious challenge to physicians. Surgery may be indicated in selected cases following failure of appropriate conservative treatment. For decades, the only surgical option has been spinal fusion, but its results have been inconsistent. Some prospective trials show superiority over usual conservative measures while others fail to demonstrate its advantages. In an effort to improve results of fusion and to decrease the incidence of adjacent segment degeneration, total disc replacement techniques have been introduced and studied extensively. Short-term results have shown superiority over some fusion techniques. Mid-term results however tend to show that this approach yields results equivalent to those of spinal fusion. Nucleus replacement has gained some popularity initially, but evidence on its efficacy is scarce. Dynamic stabilisation, a technique involving less rigid implants than in spinal fusion and performed without the need for bone grafting, represents another surgical option. Evidence again is lacking on its superiority over other surgical strategies and conservative measures. Insertion of interspinous devices posteriorly, aiming at redistributing loads and relieving pain, has been used as an adjunct to disc removal surgery for disc herniation. To date however, there is no clear evidence on their efficacy. Minimally invasive intradiscal thermocoagulation techniques have also been tried, but evidence of their effectiveness is questioned. Surgery using novel biological solutions may be the future of discogenic pain treatment. Collaboration between clinicians and basic scientists in this multidisciplinary field will undoubtedly shape the future of treating symptomatic disc degeneration.
... 8,10 A temperature-controlled thermal resistive coil provides conductive heating of the anulus in a temperature range that is thought to provide local denaturing of collagen fibrils, cauterize granulation tissue, and coagulate nerve fibers. 6,14,42 These therapeutic mechanisms occur without concomitant destabilization of the involved spinal motion segment(s). 26 Using physical examination, MR imaging, and discography findings, a carefully selected group of 50 consecutive patients with lumbar discogenic pain were identified, underwent IDET, and were prospectively followed up for 24 months using a standard battery of patient-reported outcome measures. ...
Article
Full-text available
Degeneration of the intervertebral disc can be the source of severe low-back pain. Intradiscal electrothermal therapy (IDET) is a minimally invasive treatment option for patients with symptomatic internal disc disruption unresponsive to conservative medical care. This study was undertaken in the neurosurgical setting to evaluate 24-month pain and functional outcomes and predictors of clinical success in patients with discogenic back pain treated with IDET. Using MR imaging and discography findings, 50 patients with lumbar discogenic pain were identified, underwent IDET treatment, and were followed up for 24 months. Outcomes included assessments of back pain severity based on an 11-point numeric scale and back function based on the Oswestry Disability Index. The Prolo scale was applied to determine economic and functional status at 24 months. There was an average 68 and 66% improvement in back pain and function, respectively, between pretreatment and 24 months after treatment (p < 0.0001 for both comparisons). A maximum score of 5 on the Prolo scale for economic and functional status was achieved in 63 and 22% of patients, respectively. The global clinical success rate was 78% (39 of 50 patients) based on no reoperations at the affected level due to persistent symptoms, with a >or= 2-point improvement in pain severity and a >or= 15-point improvement in back function. Predictors of 24-month clinical success included discographic concordance (p < 0.0001), a high-intensity zone on MR imaging (p = 0.0003), low Pfirrmann grade (p = 0.0002), and more extensive anulus coverage (p < 0.0001). There were no procedure-related adverse events. The findings of this study suggest that durable clinical improvements can be realized after IDET in highly select surgical candidates with mild disc degeneration, confirmatory imaging evidence of anular disruption, and highly concordant pain provocation on low-pressure discography.
Article
Low back pain (LBP) has become a main cause of absenteeism and disability in industrialized societies. Chronic LBP is an important health issue in modern countries. Discogenic LBP is one of the causes of chronic low back pain. The management of chronic discogenic LBP has been limited to either conservative treatment or operative treatment. Intradiscal electrothermal therapy (IDET) is now being performed as an alternative treatment. Ninety-three consecutive patients undergoing IDET at 134 disc levels from October 2004 to January 2007 were prospectively evaluated. All patients had discogenic disease with chronic LBP, as determined by clinical features, physical examination and image studies, and had failed to improve with conservative treatment for at least 6 months. Follow-up period was from 1 week to 3 or more years postoperatively. There were 50 male and 43 female patients, with a mean age of 46.07 years (range, 21-65 years). The results were classified as symptom free (100% improvement), better (≥50% improvement), slightly better (<50% improvement), unchanged and aggravated. Eighty-nine patients were followed up in the first week; of them, 77 (86.52%) patients had improvement (4, symptom free; 45, better; and 28, slightly better). The improvement rate gradually decreased to 80.90% in 1 year; and 73.91%, in 3 years. In conclusion, IDET offers a safe, minimally invasive therapy option for carefully selected patients with chronic discogenic LBP who have not responded to conservative treatment. Although IDET appears to provide intermediate-term relief of pain, further studies with long-term follow-up are necessary.
Article
Severe discogenic pain including axial or radicular pain is not easy to treat properly. Although mechanical correction was made possible to some extent, the high incidence of failed back surgery syndrome frustrates both patients and physicians. For discogenic pain, like other disorders, pain management is the discipline of intervention, principally with the application of certain techniques, such as intradiscal electrothermal therapy, nucleoplasty, Dekompressor and targeted disc decompression (TDD). These techniques are simple to use, have low complication rates and seem to be effective. The goals of interventional pain management include decrease the frequency and intensity of the pain, increase daily activities, quality of life, enhancement of coping skills and lowering narcotic use and/or other pain medications.
Article
Chronic low back pain is a common problem in primary care. A history and physical examination should place patients into one of several categories: (1) nonspecific low back pain; (2) back pain associated with radiculopathy or spinal stenosis; (3) back pain referred from a nonspinal source; or (4) back pain associated with another specific spinal cause. For patients who have back pain associated with radiculopathy, spinal stenosis, or another specific spinal cause, magnetic resonance imaging or computed tomography may establish the diagnosis and guide management. Because evidence of improved outcomes is lacking, lumbar spine radiography should be delayed for at least one to two months in patients with nonspecific pain. Acetaminophen and nonsteroidal anti-inflammatory drugs are first-line medications for chronic low back pain. Tramadol, opioids, and other adjunctive medications may benefit some patients who do not respond to nonsteroidal anti-inflammatory drugs. Acupuncture, exercise therapy, multidisciplinary rehabilitation programs, massage, behavior therapy, and spinal manipulation are effective in certain clinical situations. Patients with radicular symptoms may benefit from epidural steroid injections, but studies have produced mixed results. Most patients with chronic low back pain will not benefit from surgery. A surgical evaluation may be considered for select patients with functional disabilities or refractory pain despite multiple nonsurgical treatments.
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We evaluated the efficacy and safety of chemonucleolysis and intradiscal electrothermal therapy (IDET) on the basis of the data presented in recently published papers with respect to pain relief, function, and complication rates. Detailed searches for English and German articles published between 2003 and 2008 were performed in a number of electronic databases. Further publications were identified by manual search. For summarizing the evidence, we considered only systematic reviews and controlled studies. The internal validity of reviews and studies was judged by two authors independently. Data extraction was performed by one author, and the extracted data was checked for completeness and correctness by a second author. The evidence of the efficacy of chemonucleolysis using chymopapain or collagenase is summarized in two recent, high-quality systematic reviews. We found 5 controlled studies evaluating nucleolysis using an oxygen-ozone mixture (O 2 O 3 -nucleolysis). Some of those studies were of limited methodological quality, but all showed the efficacy of O 2 O 3 -nucleolysis in comparison to microdiscectomy or the use of alternative substances. There is hardly any data regarding O 2 O 3 -nucleolysis complications. Regarding IDET, the authors of the 6 identified systematic reviews come to different conclusions about the efficacy of the procedure. The results of the 3 included controlled IDET studies, of which 2 are of high methodological quality, are also conflicting. The complication rates range from 0 to 15 %. In summary, the evidence of efficacy is presently more compelling for chemonucleolysis than for IDET. This may also be because indications for chemonucleolysis are more firmly established. However, safety aspects should be better evaluated and presented in the literature.
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Pain is a common problem among the elderly. The entire scope of chronic pain relief strategies used by community elderly is still unclear. A limited number of studies have investigated this issue from diverse culture perspectives. In the present study, we investigated the use and perceived effectiveness of pain relief strategies adopted by the elderly; gender differences between frequently used relief strategies were also explored. Two hundred nineteen participants living in Taiwan City, Taiwan, were recruited by a random sampling method and interviewed face to face. The prevalence of chronic pain among the elderly was 42.0% (n = 92). The elderly tended to adopt multiple strategies (mean ± SD = 9.08 ± 3.56; range = 2-18) to relieve their chronic pain. In three domains of pain relief strategies, conventional medicine was used more frequently than complementary and alternative medicine and psychologic approaches. Most pain relief strategies were ineffective. Among the 22 strategies used, no strategy was reported as "much improved" by a majority of users. The top five pain relief strategies used by men and women were the same. Elderly women tended to adopt more psychologic approaches, such as acceptance and ignoring to relieve pain, than men. The findings suggest that nurses should pay more attention to the issue of chronic pain relief and provide the elderly with more effective pain relief strategies.
Article
Radiofrequency lesioning is useful in chronic pain treatment in certain situations. It is not a new technique as a neuroablative technique, Kirschner, in 1931, introduced the diatlermocoagulation of Gasser's ganglia to treat trigeminal neuralgia. It is a percutaneous treatment, minimally invasive indicated in back pain. In this pathology it was first indicated for the Facet syndrome, which clinically is a kind of mechanical pain in the lumbar area that can be induced by pressing two or three centimetres from the midline and moving the patient to hyperextension (arc sign). The pulsed radiofrequency technique is harmless and offers a new treatment option in pathologies in which conventional radio frequency could not be used. The long-term evaluation of the results in radicular or discal pain will define its indications.
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Oynanmaya başladığı ilk günden bugüne, büyük değişim ve gelişim gösteren kadın futbolu, istatistiklere göre Avrupa’nın 1 numaralı kadın takım sporu konumundadır. Kadın futbolunun lokomotif organizasyonlarının başında, 2001 yılından bu yana üst düzey kulüpler arasında düzenlenmekte olan “UEFA Kadınlar Şampiyonlar Ligi” (UWCL) gelmektedir. Bu düzeyde büyük ölçekli turnuvaların, bir sporun gelişimine önemli katkılar sağladığı bilinmektedir. Son yıllarda UEFA’nın reform niteliğinde yaptığı uygulamalarla büyük değişime uğrayan turnuva; futbolculara daha çekici bir ortam, seyircilere daha kaliteli futbol, kulüplere ise daha büyük ekonomik katkılar sunmayı hedeflemektedir. Futbol otoriteleri, UEFA Kadınlar Şampiyonlar Ligi’nin parlayan bir organizasyon olma yolunda ilerlediğini değerlendirmektedirler. Araştırmamızda, kadın futbolunun en önemli organizasyonlarından biri olan UEFA Kadınlar Şampiyonlar Ligi’nde oynanan müsabakalarının istatistiki yönden analiz edilmesi amaçlanmıştır. Çalışma, güncel durumun ortaya konulabilmesi amacıyla 2018-2019, 2019-2020 ve 2020-2021 sezonları ile sınırlandırılmıştır. Verilerin toplanması aşamasında Union of European Football Associations (UEFA) resmi web sitesi kayıtları esas alınmıştır. Araştırmaya konu toplam 325 müsabakaya ilişkin resmi müsabaka raporları incelenmiş ve elde edilen veriler SPSS 25.0 programına aktarılmıştır. Analiz yöntemi olarak tanımlayıcı istatistikler kullanılmıştır. Araştırma bulguları ışığında öne çıkan önemli sonuçlar şöyledir; UEFA Kadınlar Şampiyonlar Ligi’nde ev sahibi takım olma avantajının kazanmaya olan etkisi %7,4’dür. Deplasman takımlarının ev sahibi takımlara oranla daha fazla sarı kart gördüğü, kırmızı kartlarda ise anlamlı bir farklılık bulunmadığı tespit edilmiştir. En sık rastlanılan skorlar, ev sahibi takımların 2-0’lık ve deplasman takımlarının 1-0’lık galibiyetleridir. Oynanan hemen hemen her müsabakada gol atıldığı ve golsüz biten müsabakaların oranının sadece %1,2 olduğu saptanmıştır. Müsabaka başı gol ortalaması 3,94 olarak bulunmuştur. Gollerin önemli bir bölümünün müsabakaların son 15 dakikası ve ikinci yarının sonuna eklenen ilave süre içerisinde atıldığı tespit edilmiştir. Yaklaşık dört müsabakadan birinde takımların beş veya daha farklı galibiyetler elde ettiği izlenmektedir (%22,5). Gol, izleyicileri futbol müsabakalarını seyretmeye yönelten unsurların başında gelmektedir. Ancak, liglerde farklı skorların sıklıkla yaşanması, bu kez müsabakaları sıkıcı bir hale getirebilir ve izleyiciyi seyirden uzaklaştırabilir. Yüksek farklı skorların sayıca fazla oluşunun, UEFA Kadınlar Şampiyonlar Ligi’nde yer alan takımlar arasındaki güç dengesizliğini gösterir nitelikte olduğu söylenilebilir. Son yıllarda önemli kulüplerin kadın futbol takımlarını kurmasının, yakın gelecekte saha içi rekabeti arttıracağı ve güç dengesinin sağlanması yolunda önemli düzeyde katkılar sağlayacağı öngörülmektedir.
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Internal annular disruption (IAD) of the intervertebral disc is a common source of low back pain. Roughly 25% of persistent low back pain comes from IAD. The pathophysiology is most likely irritation of nerves growing in the damaged inner annulus during the attempt to heal the annular tears. The natural history is for pain from IAD to persist. Diagnosis is best done by discography, but that technique has been criticized, so that access to discography is limited.
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Approximately 40% of low back pain is caused by intervertebral disc pathology. While surgery may be an effective treatment for patient refractory to conservative management, it may not reliably provide symptomatic relief and may be associated with significant morbidity. Minimally invasive procedures such as nucleoplasty, neuronal cryotherapy, and percutaneous intradiscal thermocoagulation have been demonstrated to be efficacious in the treatment of low back pain secondary to intervertebral disc pathology and offer a viable therapeutic modality prior to undergoing surgery. Nucleoplasty involves the use of a high energy source to mechanically remove the soft tissue that is attributed to the source of pathology causing pain. Cryotherapy employs cold temperatures to create an anesthetic block by inducing neurolysis of the nervous tissue innervating the painful area. Percutaneous intradiscal thermocoagulation provides pain relief by employing a heated probe to produce structurally advantageous changes to the intervertebral disc and concomitantly ablate nociceptive nerves of the pathological disc. Together, these minimally invasive options to treating low back pain that is secondary to pathology of the intervertebral disc may offer improved pain in function to otherwise surgical patients.
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Low back pain (LBP) is a very common and disabling disorder. Many causes of low back pain differ depending on the patient population; mechanical conditions are the most common ones, including facet joint disease, discogenic pain, spinal stenosis, disc herniations, and spondylolysis. Discogenic pain accounts for 30 to 40% of patients with LBP, and multiple interventional therapies have been developed to treat this condition. Intradiscal electrothermal therapy (IDET) is a minimally invasive surgical (MIS) procedure for the treatment of discogenic chronic low back pain. The technique involves applying heat to the annulus fibrosus through a catheter with a temperature-controlled thermal resistive heating coil. The goal of thermal disc treatment is to damage the nerve fibers, shrink collagen, and stiffen the disc tissue; this might seal any small tears and limit the expression of matrix components.
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Minimally invasive techniques can be a valuable alternative to traditional surgery with low cost, low risk of complications, high utility, and high reproducibility without preventing the surgery at later date if they should fail. All techniques can be performed under computed tomography or fluoroscopy guidance and under local anesthesia in outpatient surgery. All procedures can be performed at the cervical or lumbar level. The rationale for all percutaneous treatments is to reduce intradiskal pressure in different ways, creating the space required for retropulsion of the disk.
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The history and evolution of minimally invasive spine interventions were based primarily on modifications to technique and technology, including improvements in illumination, magnification, and instrumentation, as well as the technological development and abandonment of several techniques. This chapter reviews and highlights historical accounts of some of the main technological advances that shaped modern minimally invasive spinal interventions.
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Лечението на лумбалната дискова херния е предмет на постоянна дискусия между терапевти и спинални хирурзи. В повечето случаи хирургичното лечение бързо облекчава болевата симптоматика, заедно с възстановяване на функционалността на пациента. Използването на операционен микроскоп при хирургичното лечение ( Ящагрил, Каспар 1977г.) се налага като „златен стадарт“ през 80-те години на 20-ти век. В последните години навлизат разнообразни софистикирани методики, изискващи значителен финансов ресурс и клиничен опит. Темата е свързана с проучване и оценка на резултатите от лечението на лумбалната дискова херния (лДХ) чрез отворена стандартна дискектомия (СОД), микродискектомия (МД), сравнени с резултати от консервативно лекувани пациенти. Използвани са общоприети критерии за включване в проучването и отчитане на изхода: визуална аналогова скала (VAS), ODI (обективизиране на функционална инвалидност в ежедневието на пациента), ЯМР скала на Phirman (ЯМР оценка на интервертебралния диск), MacNaab критерий (ниво на удоволетвореност на пациента след оперативното лечение). Проучени са ранните следоперативни усложнения (до 30-ия ден) по скалата на Cliven-Dindo. Акцент на монографията е клиничната ефективност на СОД, която остава актуална методика в арсенала на опитен хирург, статистически доказано в резултатите и изводите на този труд.
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Discogenic low back pain resulting from internal disc disruption can be severely disabling, clinically challenging, and expensive to treat. Previously, when conservative care had been exhausted, open surgical intervention such as spinal fusion or artificial disc replacement was the only treatment option for these patients. Intradiscal electrothermal therapy (IDET), a minimally-invasive technique performed in the outpatient setting, offers an intermediate intervention between conservative care and surgery. Specific selection criteria have been refined that identify patients for treatment with IDET, ensuring maximal clinical benefit and appropriate use of healthcare resources. Indications for use were developed from review of selection criteria from published clinical reports and review articles of IDET, and further refined by identifying components with the strongest positive predictive value and by direct physician feedback. Final indications for use consist of clinical and imaging criteria. There are 5 compulsory indications for use: 1) persistent axial low back pain +/- leg pain and non-responsive to > or = 6 weeks of conservative care; 2) history consistent with discogenic low back pain without marked lower extremity neurological deficit; 3) one to 3 desiccated discs with or without small, contained herniated nucleus pulposus by T2-weighted magnetic resonance imaging, with at least 50% remaining disc height; 4) concordant pain provocation by low pressure (< 50 psi above opening pressure) discography; and, 5) posterior annular disruption by post-discography computed tomography. Using these patient selection characteristics, approximately 3 of 4 IDET-treated patients should achieve a minimal clinically important improvement in pain and disability.
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Intradiscal electrothermal annuloplasty (IDET) is a minimally invasive procedure for managing chronic discogenic low back pain (LBP). Although there have been numerous reports of IDET outcome rates, few have dissected the detailed factors affecting those outcomes. To evaluate how heating variables and the number of catheters used affect the outcomes and pain flare-up in LBP patients treated with IDET. Retrospective analysis. Data were gathered on the basis of chart records from January 6, 1999 to January 6, 2000. Twenty-five cases treated at a single level with disc protrusion < or = 2 mm, nonfocal neurological abnormalities, and positive discogram with annular tear were studied. Six patients were unavailable for follow-up at 16 months. All assessments were incorporated into our own evaluation sheet, completed before the procedure and at follow-up. Assessments included the following: 1) Visual Analog Scale (VAS) and 2) Back Pain Improvement Scales (BPI) preoperatively and at 8 and 16 months post-procedure. Post-procedure flare-up of the pain was defined as the pain aggravation after the IDET procedure from the pre-procedure baseline pain. It was evaluated by a 10-point numeric rating scale, ranging from no aggravated pain "0" to the worst aggravated pain "10". Patients were partitioned into a single-catheter group and a double-catheter group. In these two groups, statistical analyses were done to compare the outcomes and flare-up duration and intensity. In each catheter group, the correlation coefficients were analyzed between heating variables such as heating duration/temperature and two outcome scales. Then, two outcome scales relative to intensity and duration of post-IDET flare-up were analyzed with Pearson's correlation. Also the combined effect of the heating duration and temperature was evaluated as a thermal dosage, which is the total amount of heat developed during the procedure. It was calculated by multiplying the temperature and its heating duration above a starting temperature of 65 degrees C. Comparing the single- and double-catheter groups, patients placed in the single-catheter group showed significantly shorter flare-up duration (11.00+/-19.17 vs. 24.89+/-20.84 days, p < .05). In the single-catheter group, the flare-up duration manifested moderate linear correlation with heating variables (0.580 with temperature, 0.519 with thermal dosage, p < .05). Also, the improvements of pain with VAS displayed moderate reverse correlation with heating variables at 8 months (-.436 with temperature, -0.439 with thermal dosage, p < .1). In the double-catheter group, the Back Pain Improvement% had strong reverse correlations with temperature and thermal dosage at 8 months (-.735 and -.729, p < .05). The correlation between the improvement of VAS and temperature yielded a moderate reverse relationship (-.619, p < 0.1). These correlations were not, however, observed at 16 months in either the single- or double-catheter groups. Higher temperatures and larger total heating doses during IDET procedures with catheters placed in the outer annulus may increase the duration of post-procedure pain flare-ups and lead to less favorable outcomes at 8 months follow-up. The long-term outcomes at 16 months may, however, not be affected by these heating variables.
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Chronic lower back pain is one of the most common musculoskeletal problems; it is also the most expensive industrial injury. Not surprisingly, many treatments have been developed to combat this expensive and debilitating condition. One of these, intradiscal electrothermal treatment (IDET), was developed for patients with chronic discogenic lower back pain who failed to improve with any of the wide variety of non- surgical treatments. The present study sought to evaluate the efficacy of IDET for patients with chronic lower back pain. Twenty-five patients were enrolled in this prospective study; the patients received IDET between June 2001 and June 2003. MRI was used to confirm the diagnosis of internal disc disruption in all patients. The patients then underwent a pre-operative provocative test and discography. The follow-up duration was at least 1 year in all cases, and the visual analogue scale, recovery rate, and satisfaction of each patient were evaluated. The average age of the patients was 32 years (age range 18 to 49 years), and the patient group was 33% male and 67% female. Of the 25 patients, 5 underwent lumbar fusion surgery within 1 year of IDET. After IDET, 8 patients (32%) reported more pain than before, 14 patients (56%) reported less pain, and 3 patients (12%) experienced no change. Twelve patients (48%) were satisfied with IDET, 11 (44%) were dissatisfied, and 2 (8%) were undecided about the treatment. At least 1 year after IDET, nearly half the study patients were dissatisfied with their medical outcome. Consequently, 5 patients (20%) underwent fusion surgery at 1 year after IDET. Although other studies have shown good results with IDET for at least 2 years, this investigation suggests the IDET may be somewhat less effective. In order to firmly establish the efficacy of IDET for treating chronic discogenic lower back pain, additional studies with larger numbers of patients evaluated over longer time periods are recommended.
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A prospective, randomized, double-blind, placebo-controlled trial of intradiscal electrothermal therapy (IDET) for the treatment of chronic discogenic low back pain (CDLBP). To test the safety and efficacy of IDET compared with a sham treatment (placebo). In North America alone, more than 40,000 intradiscal catheters have been used to treat CDLBP. The evidence for efficacy of IDET is weak coming from retrospective and prospective cohort studies providing only Class II and Class III evidence. There is one study published with Class I evidence. This demonstrates statistically significant improvements following IDET; however, the clinical significance of these improvements is questionable. Patients with CDLBP who failed to improve following conservative therapy were considered for this study. Inclusion criteria included the presence of one- or two-level symptomatic disc degeneration with posterior or posterolateral anular tears as determined by provocative computed tomography (CT) discography. Patients were excluded if there was greater than 50% loss of disc height or previous spinal surgery. Fifty-seven patients were randomized with a 2:1 ratio: 38 to IDET and 19 to sham procedure (placebo). In all cases, the IDET catheter was positioned to cover at least 75% of the annular tear as defined by the CT discography. An independent technician connected the catheter to the generator and then either delivered electrothermal energy (active group) or did not (sham group). Surgeon, patient, and independent outcome assessor were all blinded to the treatment. All patients followed a standard postprocedural rehabilitation program. Independent statistical analysis was performed. Low Back Outcome Score (LBOS), Oswestry Disability Index (ODI), Short Form 36 questionnaire (SF-36), Zung Depression Index (ZDI), and Modified Somatic Perceptions Questionnaire (MSPQ) were measured at baseline and 6 months. Successful outcome was defined as: no neurologic deficit, improvement in LBOS of greater then 7 points, and improvement in SF-36 subsets (physical function and bodily pain) of greater than 1 standard deviation. Baseline demographic data, initial LBOS, ODI, SF-36, ZDI, and MSPQ were similar for both groups. No neurologic deficits occurred. No subject in either arm showed improvement of greater than 7 points in LBOS or greater than 1 standard deviation in the specified domains of the SF-36. Mean ODI was 41.42 at baseline and 39.77 at 6 months for the IDET group, compared with 40.74 at baseline and 41.58 at 6 months for the placebo group. There was no significant change in ZDI or MSPQ scores for either group. The IDET procedure appeared safe with no permanent complications. No subject in either arm met criteria for successful outcome. Further detailed analyses showed no significant change in outcome measures in either group at 6 months. This study demonstrates no significant benefit from IDET over placebo.
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Smith and Nephew (Endoscopy division, Andover, MA, USA) have estimated that 60,000 Intra-Discal Electrothermal Therapy (IDET) procedures have been performed world wide up to June 2005. Despite the large number of procedures performed, a critical appraisal of the evidence of efficacy of IDET has not appeared in the literature. This paper reviews the current evidence of clinical efficacy for IDET obtained via a systematic review of the literature. Studies were included if they used at least one of four specified primary outcome measures; pain intensity as assessed by a visual analogue score (VAS), global measurement of overall improvement, back specific functional status such as Oswestry disability Index (ODI) and return to work. Levels of evidence were assigned according to the hierarchy described by the Oxford Centre for Evidence-Based Medicine (www.cebm.net). Papers addressing possible mechanisms of action of IDET were not considered as the focus of the literature review was clinical effectiveness. Eleven prospective cohort studies (level II evidence) were reported on a total of 256 patients with a mean follow-up of 17.1 months (range 12-28 months). The mean improvement in the VAS for back pain was 3.4 points (range 1.4-6.5) and the mean improvement in ODI was 5.2 points (range 4.0-6.4). A total of 379 patients were reported in five retrospective studies (level III evidence). Between 13 and 23% of patients subsequently underwent surgery for low back pain within the study period. Two randomised controlled trials of IDET have been reported in the literature. The first randomised 64 patients (37 to IDET, 27 to Sham). The advantage for IDET patients amounted to 1.3 points on the VAS and seven points on the ODI. The second study randomised 57 subjects (38 to IDET, 19 to Sham) and showed no benefit from IDET over placebo. The evidence for efficacy of IDET remains weak and has not passed the standard of scientific proof.
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This was a pilot study to test the potential effectiveness of intradiscal restorative injection therapy and compare with intradiscal electrothermal therapy (IDET). Thirty-five patients for intradiscal injection and seventy-four for IDET took part in the study. All patients had intractable chronic discogenic low back pain, confirmed by discogram study. Injection solution consisted of glucosamine and chondroitin sulfate combined with hypertonic dextrose and dimethylsulfoxide. Outcome was rated as 0-10 on visual analog scale (VAS), satisfaction rate, and flare up before and after the procedures. Post-procedure, patients were followed from 6 months to 18 months. Pain relief was statistically significant for both procedures, but slightly better for injections (2.2 VAS) than for IDET (1.27 VAS). 47.8% of IDET patients reported that they felt better, whereas 65.6% of injection patients reported this outcome. Among IDET patients, 35.8% reported they were worse, while no restorative injection patient reported worsening of pain. Post-procedure flare-up occurred more frequently after restorative injection (81%) than after IDET (68.9%) and was more severe (7.9 versus 6.1 VAS, respectively). However, the duration of pain flare-up was notably shorter for restorative injections (8.6 days) than for IDET (33.1 days). Biochemical intradiscal restorative injections may be useful to reduce pain and disability in patients with chronic discogenic low back pain, and have clinically similar efficacy to IDET, but with improved cost-benefit ratio. The results of this study indicate that controlled random prospective comparative studies need to be performed to establish the efficacy of this treatment.
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To determine the long-term efficacy of IDET in the treatment of chronic lumbar discogenic pain. Prospective case series clinical outcome study. IDET was performed on 62 consecutive patients with chronic discogenic pain of greater than 6 months duration and consecutively enrolled in a non-randomized prospective case series outcome study. Outcome measures included visual numeric pain scale (VNS) for low back (LB) and lower extremity (LE) pain, Roland-Morris disability scale (RM), and North American Spine Society (NASS) patient satisfaction index. Outcome success was defined as a change of more than 2 points on VNS and RM as well as a positive NASS satisfaction response. Data were collected at baseline and post-procedure at 1, 3, and 6 months and then annually for up to 4 years. Fifty-one out of 62 patients (82%) were available for a minimum of 2-year follow-up. Average age was 41.4 years; average symptom duration was 46 months; and average follow-up was 34 months. Overall, there was statistically significant improvement in LB-VNS, RM, and LE pain scores of 3.2, 6.6, and 2.3 (p<0.001), respectively. Twenty-seven of 51 (53%) patients demonstrated clinically significant VNS and RM improvements of greater than 2. On NASS index, 63% (32/51) responded positively. Neither the number of disc levels treated nor the insurance status of patients made any difference in outcome. IDET appears to be an effective treatment for chronic lumbar discogenic pain in a well-selected group of patients with favorable long-term outcome.
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A growing number of patients suffer from severe low back pain of discogenic origin that is not responsive to conservative medical management. These patients must consider the option of surgical spinal fusion or minimally-invasive intradiscal electrothermal therapy (IDET). To conduct a systematic review of clinical outcomes in patients undergoing spinal fusion or the intradiscal electrothermal therapy (IDET) procedure for intractable discogenic low back pain. Systematic literature review. English-language journal articles published from January 1995 to December 2005 were identified through computerized searches of the PubMed database and bibliographies of identified articles and review papers. Articles were selected if disc degeneration or disruption was the primary indication for spinal fusion or the IDET procedure and if follow-up outcome data included evaluations of back pain severity, condition-specific functional impairment and/or health-related quality of life. The literature reviewed encompassed 33 spinal fusion articles: 10 randomized controlled trials, 1 nonrandomized controlled trial, 9 before-after trials, and 13 case series. There were 18 IDET articles: 2 randomized controlled trial, 2 nonrandomized controlled trials, 11 before- after trials, and 3 case series. Data were extracted and summarized on patient characteristics, surgical methods, and clinical outcomes. Overall, there were similar median percentage improvements realized after spinal fusion and the IDET procedure, respectively, for 2 of the 3 outcomes evaluated: pain severity (50%, 51%), back function (42%, 14%) and quality of life (46%, 43%). There was an identifiable randomized controlled trials trend of both treatments reporting a smaller magnitude of improvement in all 3 primary outcomes (pain severity, back function, quality of life) compared to other types of trials. Perioperative complications were commonly associated with spinal fusion (median: 14%, range: 2% to 54%, n = 31 study groups) whereas adverse events were rarely experienced with the IDET procedure (median: 0%, range: 0% to 16%, n = 14 studies). Randomized controlled trials of spinal fusion, in particular, had important methodological limitations. The majority of patients reported improvement in symptoms following both spinal fusion and the IDET procedure. The IDET procedure appears to offer sufficiently similar symptom amelioration to spinal fusion without the attendant complications.
Article
Study Design. A prospective, randomized, double-blind, placebo-controlled trial of intradiscal electrothermal therapy (IDET) for the treatment of chronic discogenic low back pain (CDLBP). Objectives. To test the safety and efficacy of IDET compared with a sham treatment (placebo). Summary of Background Data. In North America alone, more than 40,000 intradiscal catheters have been used to treat CDLBP. The evidence for efficacy of IDET is weak coming from retrospective and prospective cohort studies providing only Class II and Class III evidence. There is one study published with Class I evidence. This demonstrates statistically significant improvements following IDET; however, the clinical significance of these improvements is questionable. Methods. Patients with CDLBP who failed to improve following conservative therapy were considered for this study. Inclusion criteria included the presence of one- or two-level symptomatic disc degeneration with posterior or posterolateral anular tears as determined by provocative computed tomography (CT) discography. Patients were excluded if there was greater than 50% loss of disc height or previous spinal surgery. Fifty-seven patients were randomized with a 2:1 ratio: 38 to IDET and 19 to sham procedure (placebo). In all cases, the IDET catheter was positioned to cover at least 75% of the annular tear as defined by the CT discography. An independent technician connected the catheter to the generator and then either delivered electrothermal energy (active group) or did not (sham group). Surgeon, patient, and independent outcome assessor were all blinded to the treatment. All patients followed a standard postprocedural rehabilitation program. Independent statistical analysis was performed. Outcome Measures. Low Back Outcome Score (LBOS), Oswestry Disability Index (ODI), Short Form 36 questionnaire (SF-36), Zung Depression Index (ZDI), and Modified Somatic Perceptions Questionnaire (MSPQ) were measured at baseline and 6 months. Successful outcome was defined as: no neurologic deficit, improvement in LBOS of greater then 7 points, and improvement in SF-36 subsets (physical function and bodily pain) of greater than 1 standard deviation. Results. Baseline demographic data, initial LBOS, ODI, SF-36, ZDI, and MSPQ were similar for both groups. No neurologic deficits occurred. No subject in either arm showed improvement of greater than 7 points in LBOS or greater than 1 standard deviation in the specified domains of the SF-36. Mean ODI was 41.42 at baseline and 39.77 at 6 months for the IDET group, compared with 40.74 at baseline and 41.58 at 6 months for the placebo group. There was no significant change in ZDI or MSPQ scores for either group. Conclusions. The IDET procedure appeared safe with no permanent complications. No subject in either arm met criteria for successful outcome. Further detailed analyses showed no significant change in outcome measures in either group at 6 months. This study demonstrates no significant benefit from IDET over placebo.
Article
Bone cement is sometimes used for vertebral body reconstruction following tumor removal. During such procedures, the polymerization of the methyl-metacrylate in the bone cement generates heat. Such temperature increase might cause damage to the nerve roots within the spinal canal. In the present study, pig cauda equina nerve roots were subjected to controlled temperature increases by means of a heat-generating probe. A temperature of 40C applied for 5 min did not cause any changes in nerve root function. However, 70C resulted in a complete block of nerve root function within 5 min. Histological nerve fiber damage was seen after exposure to 60C and 70C. The present study provides basic knowledge of heat-resistance properties of spinal nerve roots that might be directly applicable as guidelines for safety margins during surgical spine reconstruction procedures using bone cement.
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Objective. This one-year pilot outcome study was designed to investigate prospectively a series of patients with chronic discogenic back pain who underwent intradiscal electrothermal annuloplasty (IDET). Patients with chronic discogenic low back pain usually respond poorly to conservative medical care. Spinal fusion procedures have yielded mixed results. IDET is a new procedure to heat the intervertebral disc for the purpose of relieving discogenic pain. This study presents the one-year results for the first 32 patients undergoing the IDET procedure. The objective of this article is to determine the safety and efficacy of the IDET procedure in patients with chronic discogenic back pain.
Article
Bone cement is sometimes used for vertebral body reconstruction following tumor removal. During such procedures, the polymerization of the methyl-metacrylate in the bone cement generates heat. Such temperature increase might cause damage to the nerve roots within the spinal canal. In the present study, pig cauda equina nerve roots were subjected to controlled temperature increases by means of a heat-generating probe. A temperature of 40 degrees C applied for 5 min did not cause any changes in nerve root function. However, 70 degrees C resulted in a complete block of nerve root function within 5 min. Histological nerve fiber damage was seen after exposure to 60 degrees C and 70 degrees C. The present study provides basic knowledge of heat-resistance properties of spinal nerve roots that might be directly applicable as guidelines for safety margins during surgical spine reconstruction procedures using bone cement.
Article
The purpose of this study was to evaluate the effect of temperature on shrinkage and the histologic properties of glenohumeral joint capsular tissue. Six fresh-frozen cadaveric shoulders were used for this study. Seven joint capsule specimens were taken from different regions from each glenohumeral joint and assigned to one of seven treatment groups (37 degrees, 55 degrees, 60 degrees, 65 degrees, 70 degrees, 75 degrees, 80 degrees C) using a randomized block design. Specimens were placed in a tissue bath heated to one of the designated temperatures for 10 minutes. Specimens treated with temperatures at or above 65 degrees C experienced significant shrinkage compared with those treated with a 37 degrees C bath. The posttreatment lengths in the 70 degrees, 75 degrees, and 80 degrees C groups were significantly less than the pretreatment lengths. Histologic analysis revealed significant thermal alteration characterized by hyalinization of collagen in the 65 degrees, 70 degrees, 75 degrees, and 80 degrees C groups. This study demonstrated that temperatures at or above 65 degrees C caused significant shrinkage of glenohumeral joint capsular tissue. These results are consistent with histologic findings, which revealed significant thermal changes of collagen in the 65 degrees, 70 degrees, 75 degrees, and 80 degrees C groups. To verify the validity of laser application for shrinkage of joint capsule, studies designed to compare these findings with the effects of laser energy must be performed.
Article
Glenohumeral joint capsule obtained from 42 patients who had undergone an arthroscopic laser-assisted capsular shift procedure was evaluated histologically. A total of 53 samples from the anterior inferior glenohumeral ligament of the joint capsule were collected before and at various times after the procedure (range, 0 to 38 months). Despite glenohumeral instability, joint capsule of the patients before the procedure showed no significant histologic lesions. Laser treatment significantly altered the histologic properties of the tissue as evidenced by hyalinization of collagen and necrotic cells (time 0). Tissues sampled during the short-term period (3 to 6 months) after the procedure demonstrated fibrous connective tissue with reactive cells and vasculature. Collagen and cell morphology returned to normal in the middle- to long-term period (7 to 38 months) after the procedure, while the number of fibroblasts remained elevated. Joint capsule collected from the shoulders of six patients who experienced stiffness after the procedure showed persistent synovial, cellular, and vascular reaction even after 1 year postoperatively, the cause of which is unclear. This study revealed histologic evidence of robust tissue healing and maturation after thermal treatment by the laser-assisted capsular shift procedure, although mechanical and biochemical characterization of the tissue was not evaluated. Correlation with clinical follow-up must be performed to further clarify the advantages and disadvantages of this procedure.
Article
The purpose of this study was to evaluate the thermal effect of monopolar radiofrequency energy, a potential treatment means for joint instability, on the mechanical, morphologic, and biochemical properties of joint capsular tissue in an in vivo ovine model. The energy was applied arthroscopically to the synovial surface of the femoropatellar joint capsule of 24 sheep. The sheep were sacrificed at 0, 2, 6, and 12 weeks after surgery (6 per group). Monopolar radiofrequency energy initially caused a significant decrease in tissue stiffness and an increase in tissue relaxation properties, followed by gradual improvement in the tissue's mechanical properties by 6 weeks after surgery. Microscopic examination illustrated that radiofrequency energy initially caused collagen hyalinization and cell necrosis, followed by active tissue repair. Biochemical analysis revealed that treated collagen was significantly more trypsin-susceptibile than untreated collagen at 0 and 2 weeks after surgery, indicating early collagen denaturation. This study demonstrated that this treatment initially caused a significantly deleterious effect on the mechanical properties of the joint capsule, which was associated with partial denaturation of joint capsular tissue. This was followed by gradual improvement of the mechanical, morphologic, and biochemical properties of the tissue over time.
Article
A prospective nonrandomized clinical trial. To determine the outcome in a group of patients with chronic, function-limiting low back pain who met the criteria for interbody fusion surgery, but were instead treated with an intradiscal thermal catheter (SpineCath, Oratec Interventions, Inc., Menlo Park, CA). This study represents the first reported trial of treatment for chronic discogenic low back pain with a novel thermal intradiscal catheter. The authors evaluated 25 consecutive patients. The minimum duration of nonoperative care with the authors was 6 months. The visual analog pain scores, sitting tolerance times, and SF-36 summary scores were tabulated. The mean follow-up period was 7 months, and the mean duration of symptoms 58.5 months. Of the 25 patients, 20 (80%) reported a reduction of at least 2 points in visual analog pain scores, and 18 (72%) reported an improvement in sitting tolerance as well as reduction or discontinuance of analgesic medication. Visual analog pain scores improved by a mean reduction of 3.74, a 51% change (P = 0.0001). On the SF-36 physical function subscale, 72% of the patients improved by a mean increase of 15 points (P = 0.001), a mean change of 38%, and by a mean increase of 14 points on the bodily pain subscale (P = 0.004), a mean change of 48%. A statistically significant improvement in functional outcome was obtained in patients with chronic discogenic low back pain treated thermally by the SpineCath.
Article
Prospective case series. To determine the outcome of patients with chronic low back pain whose symptoms did not improve with aggressive nonoperative care and who chose (intradiscal electrothermal anuloplasty) IDET as an alternative to chronic pain management or interbody fusion surgery. Patients with unremitting chronic discogenic low back pain are faced with the choice of long-term pain management or fusion surgery. Intradiscal electrothermal anuloplasty (IDET) was developed as an alternative minimally invasive treatment. Sixty-two patients from the author's practice who had chronic low back pain unresponsive to nonoperative care, no evidence of compressive radiculopathy, and concordant pain reproduction at one or more disc levels on provocative discography were enrolled in the study. Visual analog scale (VAS) pain scores and Short Form (SF)-36 Health Status Questionnaire Physical Function subscale and SF-36 Bodily Pain subscale scores were assessed at baseline and at least 1 year later. Mean follow-up was 16 months, and mean preoperative duration of symptoms was 60 months. Baseline and follow-up outcome measures demonstrated a mean change in VAS score of 3.0 (P < 0.001), mean change in SF-36 physical function of 20 (P < 0.001), and mean change in SF-36 bodily pain of 17 (P < 0.001). Symptoms improved in 44 (71%) of 62 of the study group on the SF-36 physical function subscale, in 46 (74%) of 62 on the SF-36 Bodily Pain subscale, and in 44 (71%) of 62 on the VAS scores. Twelve (19%) of 62 of the patients did not show improvement on any scale. A cohort of patients with chronic unremitting low back pain of discogenic origin whose symptoms had failed to improve with aggressive nonoperative care demonstrated a statistically significant and clinically meaningful improvement on the SF-36 and the VAS scores at a minimum follow-up of 1 year after IDET. The positive results should be validated with placebo-controlled randomized trials and studies that compare IDET with alternative treatments.-
Article
Case-control study. To determine the prima facie efficacy of intradiscal electrothermal anuloplasty (IDTA). Although it is being used increasingly as a putative treatment for internal disc disruption, no studies have been published on the efficacy of IDTA. Fifty-three patients with back pain determined by computed tomographic (CT)-discography to be due to internal disc disruption were offered treatment. The outcomes of 35 patients treated with IDTA were compared with those of a convenience sample of 17 patients treated with a physical rehabilitation program, by using a visual analog pain scale, use of analgesics, and return to work as measures. At 3 months, only one control patient obtained any significant degree of relief of pain, compared with 23 in the index group. Relief of pain was sustained at 6 and 12 months and was associated with improvement in disability, reduced drug use, and a return to work rate of 53%. Depending on the stringency of criteria used, the success rate of IDTA may be as low as 23% or as high as 60% with confidence intervals of +/-16%. In carefully selected cases, IDTA can eliminate or dramatically reduce the pain of internal disc disruption in a substantial proportion of patients and appears to be superior to conventional conservative care for internal disc disruption.
Article
A prospective double-blind randomized trial in 28 patients. To assess the clinical effect of percutaneous intradiscal radiofrequency thermocoagulation for reducing pain, functional disability, and physical impairment in patients with chronic discogenic low back pain. Chronic discogenic low back pain is a challenging problem in western countries. A treatment option is radiofrequency heating of the affected disc. Its clinical efficacy has never been formally tested in a controlled trial. Twenty-eight patients with a history of at least 1 year of chronic low back pain were selected on the basis of a diagnostic anesthetization of the lower intervertebral discs. Only patients with one putative painful level were selected and randomly assigned to one of two treatment groups. Each patient in the radiofrequency treatment group (n = 13) received a 90-second 70 C lesion of the intervertebral disc. Patients in the control group (n = 15) underwent the same procedure, but without use of radiofrequency current. Both the treating physician and the patients were blinded to the group assignment. Before treatment, physical impairment, rating of pain, the degree of disability, and quality of life were assessed by a blinded investigator. Eight weeks after treatment, there was one success in the radiofrequency group (n = 13) and two in the control group (n = 15). The adjusted and unadjusted odds ratio was 0.5 and 1.1, respectively (not significant). Also, visual analog scores for pain, global perceived effect, and the Oswestry disability scale showed no differences between the two groups. Percutaneous intradiscal radiofrequency thermocoagulation (90 seconds, 70 C) is not effective in reducing chronic discogenic low back pain.
Article
To assess the stability of the human lumbar cadaveric spinal motion segment before and after treatment with intradiscal electrothermal therapy (IDET). An in vitro biomechanic analysis of 5 human cadaveric spinal motion segments by using nondestructive biomechanic testing in flexion/extension, lateral bending, and axial rotation with loads of 0N, 600N, and 1200N. University-based hospital research center. CADAVERS: Spinal unit specimens (upper and middle lumbar) from 5 human cadavers (age range, 39-79yr). A spinal catheter consisting of a thermal-resistive heating coil was placed circumferentially into the outer annulus by using the standard extrapedicular discographic technique through a 17-gauge introducer needle. The disc was then heated in a saline bath (37 degrees C) from 65 degrees C up to 90 degrees C for a total of 17 minutes. The stability of the spinal segments was measured before and shortly after IDET. Stability of the spine was measured as the compliance of the spine (the angular deformation afforded by the spine under applied bending moments). With increasing preloads, there is a decrease in motion of the spinal segment in all planes of testing. However, there was no significant difference (p >.05) in the stability of the lumbar spine before and after treatment with IDET. IDET does not destabilize the spinal motion segment in vitro.
Article
To characterize descriptively the histologic and temperature effects of intradiskal electrothermal annuloplasty on human cadaveric lumbar disks. In vitro histologic study. Hospital-based soft-tissue research laboratory. CADAVERS: Six human cadaveric lumbar disks, from 5 cadavers aged 39 to 79 who died from nonspine-related causes. Intradiskal electrothermal therapy (IDET) by using a standard high-temperature heating protocol with the temperature of the probe gradually increased from 65 degrees C to 90 degrees C over 16.5 minutes. Disks were stained and examined by light microscopy and electron microscopy. Temperatures in outer annulus, gross macroscopic changes, and histologic damage. Gross inspection showed a small circumferential area of tissue alteration localized to the posterior annulus but not extending to the endplates. Light microscopy of the posterior aspect of the lumbar disks showed denaturation, shrinkage, and coalescence of annular collagen; the anterior portions, which served as internal controls, showed no evidence of damage. The endplates were structurally preserved and showed no evidence of damage. Electron microscopy showed extensive collagen disorganization, decreased quantity of collagen, collagen fibril shrinkage, and chondrocyte damage when compared with a control portion. The temperature curves showed parallel changes in temperature at the level of the probe and at the posterior portion of the disk. IDET raises temperatures sufficiently to induce collagen denaturation and coalescence. These histologic changes may play a substantial role in the clinical efficacy of IDET.
Article
Human cadaver lumbar spines were used to assess the acute effects of intradiscal electrothermal therapy in vitro. To determine whether intradiscal electrothermal therapy produces acute changes in disc histology and motion segment stability. Intradiscal electrothermal therapy has been introduced as an alternative for the treatment of discogenic low back pain. Several hypothesized mechanisms for the effect of intradiscal electrothermal therapy have been suggested including shrinkage of the nucleus or sealing of the anulus fibrosus by contraction of collagen fibers, and thermal ablation of sensitive nerve fibers in the outer anulus. Intradiscal electrothermal therapy was performed with the Spinecath by Oratec on 19 fresh, frozen human lumbar cadaver specimens. In a separate study, eight specimens were tested biomechanically and instrumented to map the thermal distribution, whereas five specimens were tested only biomechanically, both before and after intradiscal electrothermal therapy. Six additional specimens were heated with intradiscal electrothermal therapy, and the resulting canal was backfilled with a silicone rubber compound to allow colocalization of the catheter and anular architecture. A consistent pattern of increased motion and decreased stiffness was observed. For the specimens in which only biomechanical measurements were taken, a 10% increase in the motion, on the average, at 5 Nm torque was observed after intradiscal electrothermal therapy. No apparent alteration of the anular architecture was observed around the catheter site in the intradiscal electrothermal therapy-treated discs. The data from this study suggest that the temperatures developed during intradiscal electrothermal therapy are insufficient to alter collagen architecture or stiffen the treated motion segment acutely.
Article
Deformation of capsular tissue under constant load (creep) may lead to recurrent laxity after thermal shrinkage for shoulder instability. We investigated the effects of thermal shrinkage in a rabbit model in which the tibial insertion of the medial collateral ligament was elevated and shifted toward the joint line to create abnormal laxity. On the right side, radiofrequency electrothermal energy was applied to the shifted ligament, while the left side served as a control. Length, laxity, mass, cross-sectional area, water content, and creep behavior of the ligament were assessed at 0 (N = 8), 3 (N = 7), and 12 (N = 6) weeks postoperatively. Laxity was reduced with thermal treatment (0.65 +/- 0.31 compared with 3.33 +/- 0.25 mm). After 3 weeks, ligament mass, area, and water content were significantly increased in the thermally treated group compared with the untreated controls. At 12 weeks, cyclic creep strain remained greater than that in controls (1.25% +/- 0.65% compared with 0.93% +/- 0.22%). Although thermal shrinkage reduced laxity, there was increased potential to creep and failure at low physiologic stresses. These findings suggest that loading of thermally treated tissues should be carefully controlled during the early phase of rehabilitation after surgery.
Article
The early studies on IDET are very promising. IDET offers patients with chronic discogenic low back pain an option other than chronic pain [figure: see text] management or spinal fusion. Studies currently under way will help answer questions relative to mechanism of action, placebo effect, and biomechanical changes after treatment. The cost, morbidity, and currently observed degree of effectiveness make IDET an attractive alternative to spinal fusion for discogenic pain. This may be especially true for the young patient with preserved disc height, and patients with inoperable multilevel disease. The technology was designed to be used for a specific diagnostic subset of disc disorders by specialists skilled in performing intradiscal techniques who possess the ability to accurately diagnose and effectively manage patients with complex spinal disorders. Abuse of this ground-breaking technology can be avoided if patient selection criteria are carefully observed and only skilled, technically proficient physicians perform the procedure.
Article
Prospective longitudinal study with a minimum 2-year follow-up. To assess the long-term outcome of a group of patients with chronic discogenic low back pain who had failed to improve with comprehensive nonoperative care and who were subsequently treated with intradiscal electrothermal therapy (IDET). Previous reports of patient outcomes at 1 year after IDET have demonstrated statistically significant improvement. The study group comprised 58 patients with chronic symptoms of more than 6 months who failed to improve with nonoperative care and subsequently underwent IDET. VAS pain scores, SF-36 scores, and sitting tolerance times were collected pretreatment and at 6, 12, and 24 months. Mean duration of pre-IDET symptoms was 60.7 months. The minimum follow-up at data collection was 24 months. The study group (n = 58) demonstrated a significant improvement in pain as demonstrated by statistically significant improvement in VAS scores and bodily pain SF-36 scores. The IDET-treated group demonstrated a significant improvement in physical function as noted by statistically significant improvement in sitting tolerance times and physical function SF-36 scores. Bodily pain and physical function scores demonstrated significant improvement between the 1- and 2-year observation points. Additionally, quality of life improvement was demonstrated by a statistically significant improvement in all the SF-36 subscales. A cohort of patients with chronic discogenic low back pain who had failed to improve with comprehensive nonoperative care demonstrated a statistically significant improvement in pain, physical function, and quality of life at 2 years after IDET.
Article
Intradiscal electrothermal therapy (IDET) is a percutaneous intervention used to treat pain from internal disc disruption. We reviewed the patients who underwent this procedure in our practice. We found, in an appropriately selected group of patients, an increase in sitting and standing tolerances and a decrease in pain levels. After completion of post-IDET rehabilitation, 66% of the patients returned to work. There were no complications.
Article
The goal of this study was to evaluate the short-term effects of intradiscal electrothermal treatment (IDET) for chronic discogenic low back pain. Twenty consecutive patients with symptomatic degenerative discs were treated with IDET and evaluated preoperatively, and 3 and 6 months postoperatively. Pain was measured with a 100-mm visual analog scale (VAS) and function was evaluated with the Oswestry score and SF-36 questionnaire. The VAS scores improved by 14 mm on average (P=0.046), but the individual scores show great variation. The Oswestry scores did not improve significantly. The SF-36 showed improvement, but only for the subscales vitality (P=0.023) and bodily pain (P=0.047). Based on these results, we conclude that IDET is not effective in reducing pain and improving functional performance in a sample of 20 patients treated for chronic discogenic low back pain after 6 months follow-up.
Article
To determine the clinical efficacy of intradiskal electrothermal annuloplasty in treating patients with chronic constant lumbar diskogenic pain who have not responded to at least 6 months of aggressive nonoperative care. Prospective case series. Academic-affiliated private physiatry practice. Thirty-three patients with chronic constant lumbar diskogenic pain of more than 6 months in duration diagnosed with history and physical examination, with concordant pain on provocative pressure-controlled lumbar diskography, and with symptomatic annular tears and/or protrusions less than 5mm, who did not respond to aggressive nonoperative care. Intradiskal electrothermal annuloplasty. Visual analog scale (VAS) pain scores for the back and for the lower extremity, the Roland-Morris Disability Questionnaire (RMDQ), and the North American Spine Society Patient Satisfaction Index. A total of 33 patients, with mean age of 40 years and a mean duration of symptoms of 46 months, were observed with a mean follow-up of 15 months. Relief of pain and improvement in physical function were associated with a mean change in the VAS score of 3.9 (P<.001), a mean change in the lower-extremity VAS score of 3.7 (P<.001), and a mean change in the RMDQ of 7.3 (P<.001). For patient satisfaction, 75.7% reported that they would undergo the same procedure for the same outcome. Complete pain relief was achieved in 24% of the patients, and partial pain relief in 46% of the patients. Intradiskal electrothermal annuloplasty offers a safe, minimally invasive treatment option for carefully selected patients with chronic lumbar diskogenic pain who have not responded to aggressive nonoperative care.
Article
A bi-institutional, retrospective clinical data analysis. To determine risk factors for failure and complications of intradiscal electrothermal therapy, a treatment for discogenic back pain. Intradiscal electrothermal therapy is a relatively new treatment for discogenic back pain. Though previous studies have shown it to be an effective treatment, there are few published studies examining complications and none examining risk factors for failure. The authors treated 79 patients with discogenic back pain using intradiscal electrothermal therapy. Complications were assessed by patient report and, when indicated, further diagnostic testing. Success or failure was determined by visual analogue pain scores at 6-month follow-up. Variables examined for their relationship to failure and complications were age, sex, duration of pain, number of levels heated, smoking history, diabetes, obesity, leg pain, and previous back surgery. Forty-eight percent of patients reported more than 50% pain relief at their 6-month follow-up. There were eight complications (10%), most of which were self-limited and transient. The only risk factor associated with intradiscal electrothermal therapy failure was obesity (P = 0.01). Whereas 54% of nonobese patients reported good pain relief at 6 months, only one out of 10 obese patients had successful intradiscal electrothermal therapy. The obese patients in our study were more likely to have a complication from intradiscal electrothermal therapy than they were to obtain pain relief. The only risk factor found to be associated with IDET outcome was obesity, which was a strong predictor of failure. Obesity should be considered a relative contraindication to performing IDET.
Article
Human cadaveric lumbar spines were used to assess the temperature and thermal dose distribution during intradiscal electrothermal therapy in vitro. To determine whether intradiscal electrothermal therapy produces adequate tissue temperatures to denature annular collagen or ablate nerve cells. Several hypothesized mechanisms for the effect of intradiscal electrothermal therapy have been suggested and include: 1) shrinkage of the nucleus and/or the annulus fibrosus by contraction of collagen fibers; and 2) thermal ablation of sensitive nerve fibers in the outer annulus. Intradiscal electrothermal therapy was performed using the standard clinical protocol on 12 lumbar specimens in a 37.0 degrees C water bath using the SpineCath by Oratec. Temperatures were recorded simultaneously at 40 different locations in the disc. Thermal dose (Equivalent Minutes 43.0 degrees C) was calculated at each temperature point. The highest temperature measured (out of 520 points) was 64.0 degrees C and was within 1 mm of the heating coil. Temperatures in excess of 60 degrees C were all within 1 to 2 mm of the intradiscal electrothermal therapy catheter surface, the 50 to 60 degrees C range extended approximately 6 mm, above 48 degrees C extended approximately 7 mm, and above 45 degrees C extended to approximately 10 mm. Less than 2% of points achieved temperatures sufficient for collagen denaturation (>60 degrees C). On average, 42.5% of points accumulated >250 Equivalent Minutes 43.0 degrees C, a conservative common dose threshold for thermal necrosis of cells. The time history of thermal measurements demonstrated that the disc temperature had not reached steady state by the end of the heating protocol (16.5 minutes). Except for a very limited margin (1-2 mm) around the catheter, the temperature necessary to induce collagen shrinkage was not observed within the disc. Temperatures sufficient to ablate nerves were developed in some areas but were not reliably produced in clinically relevant regions, such as the posterior annulus. These results suggest that beneficial clinical outcomes may be critically dependent on probe placement or other factors unknown.
Article
A case of a patient in whom vertebral osteonecrosis developed after intradiscal electrothermal therapy is reported. To illustrate a potential complication of intradiscal electrothermal therapy and potential strategies to avoid it. Thermal energy delivered in a controlled fashion directly to the annular wall and disc nucleus has been developed as an alternative to surgical methods for treating internal disc disruption. Although 2-year follow-up data are available, few complications and no vertebral body injury have been reported. After intradiscal electrothermal therapy, a patient exhibited MRI changes consistent with osteonecrosis in the adjacent vertebral body. The clinical and radiologic findings are presented, along with a review of the pertinent literature. The magnetic resonance images, the temporal relation of intradiscal therapy, and the patient's clinical symptoms are consistent with focal osteonecrosis of the vertebral body. This case study highlights a potential complication of intradiscal electrothermal therapy. Catheter placement may expose cortical and cancellous bone to temperatures well within the range reported to induce necrosis. In addition, focal disruption of the endplate may prove to be a relative contraindication for intradiscal electrothermal therapy.
Article
On the basis of observational data, intradiscal electrothermal anuloplasty (IDETA) has been implemented as a treatment for back pain resulting from internal disc disruption. To assess the efficacy of IDETA. Prospective cohort study with comparison group and 2-year follow-up. Of 53 patients who satisfied the diagnostic criteria for internal disc disruption, 36 were allocated to a treatment group and 17 to a comparison group, according to whether their insurer approved treatment with IDETA. Outcomes were assessed in terms of relief of pain, return to work and use of opioids to treat persisting pain. The treatment group underwent IDETA. The comparison group underwent a conventional rehabilitation program. Outcomes were assessed at 3 months, 12 months and 2 years after treatment. As a group, the comparison patients exhibited no significant improvement in their pain at any time. One was partially relieved, but no patient was completely relieved at either 12 or 24 months. The patients treated with IDETA exhibited significant improvements in their median pain scores, which were sustained at 12 and 24 months. At 24 months, 54% of these patients had achieved at least 50% relief of their pain, no longer used opioids and were at work. Seven patients (20%) were totally free of pain and at work at 24 months. The long-term results of IDETA are stable and enduring. It is not universally successful, but 54% of patients can reduce their pain by half, and one in five patients can expect to achieve complete relief of their pain.
Article
Intradiscal electrothermal therapy (IDET) is a new treatment option for chronic discogenic low back pain that is minimally invasive and has demonstrated success rates equal to or better than those for spinal fusion at short-term follow-up. To report our experience with IDET in the management of chronic discogenic low back pain in active-duty soldiers. Consecutive case series at a US Army medical center. The primary outcome measured was a reported 50% or greater reduction in pain at latest follow-up. Additional outcomes measured included analog pain scores, satisfaction, complications, duty status and subsequent spinal surgery. Between 1999 and 2001, 41 active-duty soldiers (34 men, 7 women) underwent IDET for chronic discogenic low back pain unresponsive to nonoperative therapy. Data were collected through clinic chart review and follow-up questionnaires. Success was defined as a stated "50% decrease in pain" from baseline. During the study period, 36 of 41 patients underwent a single trial of IDET, and the remaining 5 underwent two trials of IDET. Only the results of the 36 patients who underwent one trial of IDET were used for statistical analysis. All 36 patients were available for follow-up at 6 months, whereas only 31 patients (86%) were reached for final follow-up (average, 29.7 months; range, 24 to 46). The success rate was 47% (17 of 36) at 6 months and 16% (5 of 31 patients) at latest follow-up. Although overall success rates were low, 20 of 31 soldiers (65%) had a persistent decrease in their analog pain score (average decrease of 2.5+/-1.6 on a 10-point scale), with 52% having 2-point or greater decrease. Nineteen of 31 soldiers (61%) were still on active duty at a minimum of 24 months after IDET. There were five transient complications (16%) from IDET, all reported within the first month. Seven of 31 soldiers (23%), all male, went on to spinal surgery within 24 months of failed IDET. IDET is not a substitute for spinal fusion in the treatment of chronic discogenic low back pain in active-duty soldiers. Our reasonable early results diminished with time and up to 20% of patients report worsening of baseline symptoms at final follow-up. IDET will prove its role in the treatment of chronic discogenic low back pain as more outcome data are obtained, but for now we consider it, at best, an antecedent rather than alternative to spinal fusion.
Article
The effects of intradiscal electrothermal therapy (IDET) on intervertebral discs in sheep were studied experimentally. Posterolateral annular lesions were experimentally induced and allowed to mature for 12 weeks in the intervertebral discs of sheep. IDET was performed in an attempt to denervate and repair the annular lesion. The histologic and immunohistochemical effects of IDET were studied. IDET continues to be used as a minimally invasive treatment for chronic discogenic low back pain, with success rates reported in up to 70% of cases. The mechanism of action by which IDET exerts its effect is poorly understood. Proposed mechanisms include the contraction of collagen and the coagulation of annular nociceptors. An ovine model was used firstly to induce a posterolateral annular lesion, secondly to assess the innervation of such a lesion, and thirdly to assess the effect of IDET on this innervation. Posterolateral annular incisions were made in 40 lumbar discs of 20 sheep. Twelve weeks were allowed for each annular lesion to mature. IDET was then performed in the disc with the posterolateral annular tear and in another control level. IDET was performed using a modified intradiscal catheter (Spine-CATH; Oratec Interventions, Menlo Park, CA). Temperatures were recorded in the nucleus (TN) and the posterior annulus (TPA). The spines were harvested at predetermined intervals up to 18 months. Histologic sections of the discs were graded for disc morphology to assess degeneration and immunohistochemical staining to assess potential denervation. Vascular granulation tissue consistent with a healing response was observed in the posterior annular tear of all incised discs from 12 weeks. Protein gene product 9.5 (PGP 9.5) positive nerve fibers were clearly identified in the adjacent periannular tissue and the outer few lamellae of the posterior annulus. During the IDET procedure, the mean maximum TPA was 63.6C and the mean maximum TN was 67.C.At sacrifice, the number of nerve fibers identified in the posterior annular tear was the same for those specimens that had undergone IDET and those that had not. From 6 weeks after IDET, there was evidence of thermal necrosisin the inner annulus and adjacent nucleus but sparing the periphery of the disc. Vascular granulation tissue and posterior annular neo-innervation was observed in the experimentally induced posterolateral annular lesion. IDET delivered at 90C in the sheep consistently heated the posterior annulus and the nucleus to a temperature normally associated with coagulation of nociceptors and collagen contraction. IDET did not denervate the posterior annular lesion. Thermal necrosis was observed within the inner annulus and adjacent nucleus from 6 weeks after IDET. The reported benefits from IDET appear to be related to factors other than denervation and repair.
Article
The intervertebral disc is implicated as the source of low-back pain in a substantial number of patients. Because thermal therapy has been thought to have a therapeutic effect on collagenous tissues, this technique has recently been incorporated into several minimally invasive back pain treatments. However, patient selection criteria and precise definition of optimum dose are hindered by uncertainty of treatment mechanisms. The purpose of this study was to quantify acute changes in annulus fibrosus biomechanics after a range of thermal exposures, and to correlate these results with tissue denaturation. Intact annulus fibrosus (attached to adjacent vertebrae) from porcine lumbar spines was tested ex vivo. Biomechanical behavior, microstructure, peak of denaturation endotherm, and enthalpy of denaturation (mDSC) were determined before and after hydrothermal heat treatment at 37 degrees C, 50 degrees C, 60 degrees C, 65 degrees C, 70 degrees C, 75 degrees C, 80 degrees C, and 85 degrees C. Shrinkage of excised annular tissue (removed from adjacent vertebrae) was also measured after treatment at 85 degrees C. Significant differences in intact annulus biomechanics were observed after treatment, but the effects were much smaller in magnitude than those observed in excised annulus and those reported previously for other tissues. Consistent with this, intact tissue was only minimally denatured by treatment at 85 degrees C for 15 min, whereas excised tissue was completely denatured by this protocol. Our data suggest that in situ constraint imposed by the joint structure significantly retards annular thermal denaturation. These findings should aid the interpretation of clinical outcomes and provide a basis for the future design of optimum dosing regimens.
Article
Intradiscal electrothermal therapy (IDET) is a treatment for discogenic low back pain the efficacy of which has not been rigorously tested. To compare the efficacy of IDET with that of a placebo treatment. Randomized, placebo-controlled, prospective trial. Patients were recruited by referral and the media. No inducements were provided to any patient in order to have them participate. Of 1,360 individuals who were prepared to submit to randomization, 260 were found potentially eligible after clinical examination and 64 became eligible after discography. All had discogenic low back pain lasting longer than 6 months, with no comorbidity. Thirty-seven were allocated to IDET and 27 to sham treatment. Both groups were satisfactorily matched for demographic and clinical features. IDET was performed using a standard protocol, in which the posterior annulus of the painful disc was heated to 90 C. Sham therapy consisted of introducing a needle onto the disc and exposing the patient to the same visual and auditory environment as for a real procedure. Thirty-two (85%) of the patients randomized to the IDET group and 24 (89%) of those assigned to the sham group complied fully with the protocol of the study, and complete follow-up data are available for all of these patients. The principal outcome measures were pain and disability, assessed using a visual analog scale for pain, the Short Form (SF)-36, and the Oswestry disability scale. Patients in both groups exhibited improvements, but mean improvements in pain, disability and depression were significantly greater in the group treated with IDET. More patients deteriorated when subjected to sham treatment, whereas a greater proportion showed improvements in pain when treated with IDET. The number needed to treat, to achieve 75% relief of pain, was five. Whereas approximately 40% of the patients achieved greater than 50% relief of their pain, approximately 50% of the patients experienced no appreciable benefit. Nonspecific factors associated with the procedure account for a proportion of the apparent efficacy of IDET, but its efficacy cannot be attributed wholly to a placebo effect. The results of this trial cannot be generalized to patients who do not fit the strict inclusion criteria of this study, but IDET appears to provide worthwhile relief in a small proportion of strictly defined patients undergoing this treatment for intractable low back pain.
Article
Retrospective study with independent evaluation of patient outcomes approximately 1 year post-intradiscal electrothermal therapy (IDET). OBJECTIVE.: To assess functional status, symptoms, and subsequent treatments of patients treated with IDET. IDET was introduced as a procedure for discogenic pain. Several studies reported improvement in >70% of patients. Seventeen physicians referred 60 patients. Each patient had a positive discogram and had been treated with IDET. Patients were contacted approximately 1 year post-IDET, answered a telephone interview, and completed a self-administered questionnaire. Overall patient satisfaction, pain, functional and work status, analgesic usage, and subsequent treatments were noted. Kaplan-Meier survival curve was generated to predict the percentage that would undergo lumbar surgery after IDET. Average age was 40 years (range 25-64 years) with 66% males and 34% females. Of the 44 patients who responded, 6 patients had a lumbar surgery within 1 year. Their outcomes were excluded from descriptive analysis; 97% continued to have back pain, 11 (29%) reported more pain post versus pre-IDET, 15 (39%) had less pain, and 11 (29%) reported no change; 11 (29%) reported using more pain medication post-IDET, 10 (26%) used the same, 12 (32%) used less, and 5 (13%) used none; 19 (50%) were dissatisfied with IDET, 14 (37%) were satisfied, and 5 (13%) were undecided; 20 (53%) would have the procedure again, 12 (31%) would not, and 6 (16%) were unsure. Most patients wore a brace >6 hours/day after surgery (duration 1-15 months). Sixteen (42%) were employed full-time pre-IDET and 11 (29%) were employed full-time post-IDET. At 1-year post-IDET, half of patients were dissatisfied with their outcome. The percentage of patients on disability remained constant. The estimated proportion of patients undergoing fusion was predicted to be 15% at 1 year and 30% at 2 years.
Article
Case series. To describe the outcomes of workers' compensation (WC) claimants who have had a lumbar intradiscal electrothermal therapy (IDET) procedure. IDET was developed as a less invasive treatment alternative to fusion after failure of conservative treatment for discogenic low back pain (LBP). Initial IDET case series from single practices have reported improved pain, function, and return to work outcomes. Little is known about results when performed by a variety of providers or in WC populations. LBP cases that underwent IDET between December 1, 1998 and February 29, 2000 were identified from WC records. Data sources included hardcopy claim files, administrative medical billing data, and computerized claim file narrative reports. Outcomes included narcotic use 6 months or more after IDET, additional invasive treatment after IDET (low back injections or surgery), and improved work status 24 months after IDET. One hundred forty-two cases from 23 states were identified, with 97 different providers performing the procedure. Mean duration of symptoms before IDET was 26 months. Mean follow-up duration after IDET was 22 months. Ninety-six (68%) of the cases did not meet one or more of the published inclusion criteria. Seventy-eight cases (55%) received at least two narcotic prescriptions 6 months or more after IDET. Fifty-three (37%) had at least one lumbar injection and 32 (23%) had lumbar surgery after IDET. A total of 55 (39%) were working at 24 months after IDET; of these, 28 (20%) were not working and 27 (19%) were working before IDET. Narcotic use after IDET was associated with narcotic use before IDET, the same provider performing discography and IDET (provider self-referral), and positive signs of radiculopathy (C = 0.80). Need for invasive lumbar procedures after IDET were associated with provider self-referral, narcotic use before IDET, and older age (C = 0.73). Continued work absence after IDET was associated with provider self-referral, male gender, litigation, narcotic use before IDET, and older age (C = 0.83). Conformance with published selection criteria for IDET was not associated with provider self-referral or outcomes, nor was duration before IDET associated with outcomes. The procedure may be less effective when performed by a variety of providers than suggested by initial case series performed by single providers or practices in work-related LBP cases. Provider self-referral and narcotic use before IDET are significant risk factors for poor outcomes. Randomized controlled trials are needed to determine whether there is a subset of patients with discogenic back pain who derive substantial and sustained benefit from this procedure.
Article
Temperatures were measured in human cadaveric lumbar discs during intradiscal electrothermal therapy. To determine if sufficient temperatures for collagen denaturation and nociceptive ablation can be achieved at clinically significant distances from the intradiscal electrothermal therapy heating catheter. Previous cadaveric studies have contested the ability of the intradiscal electrothermal therapy catheter to produce sufficient temperatures to denature collagen and cause neural ablation within the posterior anulus of the disc. However, these experiments used clinically unrepresentative device placements along the anterolateral anulus. Intradiscal electrothermal therapy was performed in 14 human cadaveric discs. Devices were inserted using a standard posterolateral approach to orient the heating catheter along the posterior anulus. Temperature recordings were collected using multiple sensors placed along the posterior anulus, anterior anulus, and endplates. Temperatures greater than 60 C and 65 C were achieved in 14 and 5 specimens, respectively, at distances up to 2 mm from the catheter. Between 2 and 4 mm, more than 60 C was achieved in all specimens. More than 45 C was achieved in all specimens at distances of 9 to 14 mm from the device. Temperatures sufficient for collagen denaturation and nociceptive ablation were detected at distances greater than previously documented. These data suggest that intradiscal electrothermal therapy's proposed heat-dependent mechanisms of action are achievable in most discs. Among other factors, interspecimen variability of maximum temperatures may help explain the somewhat inconsistent clinical results following intradiscal electrothermal therapy.
Article
To demonstrate the validity of placing electrodes parallel to the target nerve in lumbar radiofrequency neurotomy. Previous data on the anatomy of the lumbar dorsal rami were reviewed and a demonstration cadaver was prepared. Under direct vision, electrodes were placed on, and parallel to, the L4 medial branch and the L5 dorsal ramus. Photographs were taken to record the placement, and radiographs were taken to illustrate the orientation and location of the electrode in relation to bony landmarks. In order to lie in contact with, and parallel to, the target nerve, electrodes need to be inserted obliquely from below, so that their active tip crosses the neck of the superior articular process. At typical lumbar levels, the tip should lie opposite the middle two quarters of the superior articular process. At the L5 level, it should lie opposite the middle and posterior thirds of the S1 superior articular process. If electrodes are placed parallel to the target nerve, the lesions made can be expected to encompass the target nerves. If electrodes are placed perpendicular to the nerve, the nerve may escape coagulation, or be only partially coagulated. Placing the electrode parallel to the nerve has a demonstrated anatomical basis, and has been vindicated clinically. Other techniques lack such a basis, and have not been vindicated clinically. Suboptimal techniques may underlie suboptimal outcomes from lumbar medial branch neurotomy.
Article
Background context: The use of minimally invasive lumbar intradiscal heating techniques, including intradiscal electro-thermal therapy (IDET), endoscopic radio-frequency annuloplasty, nucleoplasty and laser discectomy, for chronic lumbar discogenic pain and contained disc herniation has recently gained popularity. The purported therapeutic mechanisms of these interventions include subtotal nuclectomy, annular nociceptor ablation, and stabilization of the annular fibers. Basic science data elucidating the biomechanical and histomorphologic alterations of heat treatments on disc remain sparse. Purpose: The purpose of this study is to examine the effects of uniform heating on biomechanical properties and histomorphology of intervertebral disc tissues using a porcine model. Study design/setting: In a laboratory setting, porcine functional spinal units consisting of vertebra-nucleus pulposus-vertebra core and porcine hamstring tendons were harvested. Studies were performed on these tissue samples by uniformly heating the specimens in a constant temperature water bath. Ten porcine lumbar disc core and twenty-five porcine hamstring tendons were utilized as the subjects for this study. The effects of uniform heat treatments on disc core and hamstring tendon were measured for shrinkage, stiffness, and load to failure strength. Histomorphological study was also carried on the same specimen. Methods: The porcine vertebra-nucleus pulposus-vertebra segments were cored to a uniform 1-cm diameter. The hamstring tendons were cut to uniform 1.2-inch lengths. The tendon specimens were divided into groups of five each and heated in constant temperature water baths of 60 degrees C, 65 degrees C, 70 degrees C, or 75 degrees C for 10 min. Unheated specimens served as controls. The disc core specimens were divided in two group of five each, and tested at room temperature or after immersion in a 70 degrees C bath. The shrinkage was monitored during immersion in the water bath. Biomechanical testing to failure was carried out using mechanical loading on an MTS servohydraulic testing machine operating under stroke control. Strength and stiffness of the tissue was determined. Histomorphology was studied by staining the specimen with hematoxylin and eosin (H&E), and examined under 200 times magnification. Non-heated controls were used for comparisons. Results: The porcine hamstring tendons had no measurable shrinkage in specimens heated up to 65 degrees C. At temperatures above 65 degrees C, the shrinkage was concluded within 2 min of immersion and 70 degrees C appeared to be the optimal temperature, as temperatures higher than this did not demonstrate incremental effects. The disc core samples were heated to 70 degrees C (optimum temperature), and there appeared to be gross contraction of the disc core circumference to visual inspection, but no measurable lengthwise shrinkage could be appreciated. Histologically, the specimens demonstrated progressive loss of individual collagen fiber outline as the temperature increased. In the tendons, at 75 degrees C all of the fibers appear to be fused together, and the voids between individual collagen fibers were no longer present. Biomechanical testing revealed that the tendons undergo a substantial reduction in stiffness after heating. The mean tendon stiffness for the unheated specimens was 19,356 psi, while the corresponding value for the heated tendons was 1023 psi. These were significantly different using the paired t-test at p=0.0043. For the disc core samples, there was no significant difference in either stiffness (p=0.182) or failure strength (p=0.998) after heating. All failures occurred in mid-substance of the specimen. Conclusions: The application of uniform heating to nucleus pulposus disc core caused visible contraction of its circumference but not lengthwise shrinkage. The same heating shrinks the hamstring tendon and reduces its stiffness. Ultimate failure strength of the disc core specimen remains unchanged. The failure data was not obtainable for the tendon due to premature slippage from the fixation apparatus before failure. The results of this study fail to support a biomechanical justification for the application of uniform heat treatment to the whole intervertebral disc. Heating annulus fibrosus and nucleus pulposus separately to specific temperatures may have potential clinical benefits.
Article
Although several studies have reported on outcomes following heating of annular tears with a thermoresistive catheter (SpineCATH), no data are available on the efficacy of thermal treatment with a flexible radiofrequency electrode (discTRODE). A prospective case-control study was conducted to determine the efficacy of radiofrequency heating of painful annular tears in the lumbar spine. After at least 6 months of conservative treatment, 46 patients were studied for the presence of single-level painful annular tears with magnetic resonance imaging and provocative discography. Thirty-one patients underwent heating of their annular tears with a flexible radiofrequency electrode placed across the posterior annulus. The remaining 15 patients, who mostly could not obtain funding for the procedure, continued with conservative management and acted as a control group. The Visual Analogue Scale (VAS), Oswestry Disability Index (ODI), and Medication Quantification Score (MQS) were obtained before and at 3-monthly intervals after treatment. The VAS decreased significantly after the radiofrequency treatment, and this decrease persisted at 12 months of follow-up. The VAS did not change over 12 months in untreated control subjects. The decrease in VAS was significantly greater in the treated patients than the control subjects. The ODI also decreased in treated patients but not in control subjects. The MQS did not change in either group over the 12-month follow-up period. Radiofrequency heating of annular tears can lead to an improvement in the pain of internal disc disruption. The improvement gained by this treatment method is significantly better than that obtained from conservative management.
Article
Two minimally invasive techniques have been used more recently as a possible treatment for painful internal disk disruption (IDD). Intradiscal thermal annuloplasty (IDTA), known as IDET, has already shown promising results in pain reduction and functional restoration. The second technique, radiofrequency posterior annuloplasty (RFA), is used in many interventional pain practices, although studies on the technique's efficacy are lacking. This study compares the effectiveness of those two methods. We matched 42 patients (21 had IDTA and 21 radiofrequency annuloplasty) for age, sex, weight, smoking history, manual labor, and number of intervertebral disks treated. Enrolled patients completed pain disability index (PDI) questionnaires before receiving either IDTA or RFA; at 2 weeks; and 2, 3, 6, 9, and 12 months following either treatment. From the third to the twelfth month after the procedure, the IDTA group had significantly lower mean pain scores than the RFA group. Visual analog scale (VAS) pain scores decreased from 6.6 +/- 2.0 before to 4.4 +/- 2.4 at 1 year after radiofrequency annuloplasty (P = 0.001), while in the IDTA group the average VAS pain score decreased from 7.4 +/- 1.9 before IDTA to 1.4 +/- 1.9 at 1 year follow-up. Similarly, PDI scores in the IDTA group had a significantly larger improvement than those for patients who received radiofrequency annuloplasty. This study shows significant improvement in pain scores and patients' PDI following IDTA but not after RFA of the intervertebral disks. IDTA appears to be more efficacious than RFA based on PDI and VAS scores measured at 1 year following procedure.
Article
Thermal energy was delivered in vivo to ovine cervical discs and the postheating response was monitored over time. To determine the effects of two distinctly different thermal exposures on biologic remodeling: a "high-dose" regimen intended to produce both cellular necrosis and collagen denaturation and a "low-dose" regimen intended only to kill cells. Thermal therapy is a minimally invasive technique that may ameliorate discogenic back pain. Potential therapeutic mechanisms include shrinkage of collagenous tissues, stimulation of biologic remodeling, and ablation of cytokine-producing cells and nociceptive fibers. Intradiscal heating was performed using directional interstitial ultrasound applicators. Temperature and thermal dose distributions were characterized. The effects of high (>70 C, 10 minutes) and low (52 C-54 C, 10 minutes) temperature treatments on chronic biomechanical and architectural changes were compared with sham-treated and control discs at 7, 45, and 180 days. The high-dose treatment caused both an acute and chronic loss of proteoglycan staining and a degradation of biomechanical properties compared with low-dose and sham groups. Similar amounts of degradation were observed in the low-dose and sham-treated discs relative to the control discs at 180 days after treatment. While a high temperature thermal protocol had a detrimental effect on the disc, the effects of low temperature treatment were relatively minor. Thermal therapy did not stimulate significant biologic remodeling. Future studies should focus on the effects of low-dose therapy on tissue innervation and pro-inflammatory factor production.
Article
Percutaneous disc decompression with the radiofrequency coblation technique has been described to treat contained, symptomatic lumbar disc herniations. In symptomatic cervical disc herniations it has been used very selectively. We report a 42-year-old female with cervical disc pathology, predominantly at C6/C7, treated with percutaneous disc decompression using coblation technology. Her complaint of cervicogenic cephalgia completely resolved, along with an 85% reduction of neck pain and upper extremity pain 6-months post-operatively. This is the first case report of chronic cervical discogenic pain being treated with this technique.
Article
This prospective, non-randomized clinical trial was designed to determine the clinical outcome of patients who underwent Intradiscal Electrotherapy (IDET) for the treatment of chronic discogenic low back pain. Twenty-seven consecutive patients undergoing IDET were prospectively evaluated. All patients, as determined by provocative discography and/or MRI, had discogenic disease with chronic low back pain and were non-responsive to conservative treatment for at least 6 months. The mean pre-operative duration of symptoms was 38 months. The American Association of Neurological Surgeons/Congress of Neurological Surgeons Joint Section Lumbar Disc Herniation Study Questionnaire, which includes the Oswestry Low Back Pain Disability Questionnaire and the Short Form (SF) -36 Health Status Questionnaire, was used. The follow-up endpoint for all patients was one year. Seventy-five percent of patients improved based upon the Oswestry Low Back Pain Disability Questionnaire while only 48% of patients were found to improve on the SF-36 Survey. The SF-36 Bodily Pain Subscale did improve relative to other subscales in 52% of patients. There was no relationship found between outcome and duration of symptoms (p= .32), number of levels treated (p= .20), or worker's compensation (p= .38). There were no complications that resulted from the IDET treatment. IDET was found to be effective in 75% of patients in improving their chronic low back pain. This did not translate into a significant improvement in the SF-36 survey scores. The risks are negligible, and recovery time is minimal. The procedure may be useful in selected patients who would otherwise undergo an interbody fusion procedure.