Richard Rauck

North Carolina Clinical Research, Raleigh, North Carolina, United States

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Publications (104)344.59 Total impact

  • Richard L Rauck, James North, James C Eisenach
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    ABSTRACT: Chronic pain may be accompanied by hyperalgesia and allodynia, and analgesic interventions may reduce these hypersensitivity phenomena. Preclinical data suggest that intrathecal clonidine and adenosine reduce hypersensitivity, but only clonidine reduces pain; therefore, we tested the effects of these interventions in patients with chronic pain. Twenty-two subjects with pain and hyperalgesia in a lower extremity from complex regional pain syndrome were recruited in a double-blind crossover study to receive intrathecal clonidine, 100 μg, or adenosine, 2 mg. Primary outcome measure was proportion with ≥30% reduction in pain 2 hours after injection, and secondary measures were pain report, areas of hypersensitivity, and temporal summation to heat stimuli. Treatments did not differ in the primary outcome measure (10 met success criterion after clonidine administration and 5 after adenosine administration), although they did differ in pain scores over time, with clonidine having a 3-fold greater effect (P = 0.014). Both drugs similarly reduced areas of hyperalgesia and allodynia by approximately 30% and also inhibited temporal summation. The percentage change in pain report did not correlate with the percentage change in areas of hyperalgesia (P = 0.09, r = 0.08) or allodynia (P = 0.24, r = 0.24) after drug treatment. Both intrathecal clonidine and adenosine acutely inhibit experimentally induced and clinical hypersensitivity in patients with chronic regional pain syndrome. Although these drugs do not differ in analgesia by the primary outcome measure, their difference in effect on pain scores over time and lack of correlation between effect on pain and hypersensitivity suggest that analgesia does not parallel antihyperalgesia with these treatments.
    Pain 01/2015; 156(1):88-95. · 5.64 Impact Factor
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    ABSTRACT: IntroductionDiscogenic low back pain (LBP) affects a considerable number of patients suffering from chronic LBP. Recently, a growing interest has emerged in minimally invasive treatment options for discogenic LBP. Intradiscal biacuplasty (IDB), which uses cooled radiofrequency technology to ablate nociceptors in the posterior aspect of the intervertebral disc, is one such option. We previously presented 6-month results of a randomized, double-blinded, sham-controlled study. Now, we present the unblinded, 12-month follow-up data for treatment patients and 6-month data for cross-over subjects from the original sham group.Methods Physical function, pain relief, and disability were assessed using the Short Form-36, numerical rating scale, and Oswestry Disability Index, respectively. Subjects were unblinded at 6 months, and those initially randomized to sham procedure were given the option to cross over to IDB.ResultsTwenty-two out of 27 subjects in the original active treatment group were followed until 12 months and had clinically significant improvements in physical function (Δ = 22) and pain (Δ = −2.9). Out of 30 subjects originally in the sham group, 24 chose to cross over, and 20 cross-over patients completed follow-up at 6 months. In cross-over patients, improvements in physical function and pain did not differ statistically from those of patients originally randomized to IDB treatment. No complications or adverse events related to the procedure were reported.Conclusions Clinically significant improvements after IDB initially reported at 6 months were maintained at 9 and 12 months. The cross-over subjects had similar improvement in all outcome measures at all observed time points.
    Pain Medicine 11/2014; · 2.24 Impact Factor
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    ABSTRACT: The Neuromodulation Appropriateness Consensus Committee (NACC) of the International Neuromodulation Society (INS) evaluated evidence regarding the safety and efficacy of neurostimulation to treat chronic pain, chronic critical limb ischemia, and refractory angina and recommended appropriate clinical applications.
    Neuromodulation 08/2014; 17(6):515-550. · 1.79 Impact Factor
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    ABSTRACT: Objectives Breakthrough cancer pain (BTCP) is associated with decreased satisfaction with around-the-clock opioid therapy. This analysis examined patient satisfaction with fentanyl sublingual spray for BTCP during the open-label titration period of a randomized, placebo-controlled study.Methods Opioid-tolerant patients with 1 to 4 daily BTCP episodes were included. During a 26-day, open-label titration phase, a successful dose (100 to 1600 mcg) of fentanyl sublingual spray was established that provided effective analgesia for 2 consecutive BTCP episodes with tolerable side effects. The Treatment Satisfaction Questionnaire for Medication (TSQM) was administered at baseline to assess satisfaction with previous BTCP medication and at the end of the titration to assess satisfaction with fentanyl sublingual spray.ResultsOf 130 enrolled patients, 115 (88.5%) had a TSQM measure at baseline and at the end of their titration period. Scores on all 4 TSQM domains increased from baseline to end of the titration, with mean (standard error [SE]) improvements of 22.3 (2.3) for effectiveness, 7.7 (3.2) for side effects, 6.8 (2.2) for convenience, and 12.9 (2.8) for global satisfaction (P < 0.05 for all). Satisfaction with symptom relief (26.1% to 77.4%) and onset of action (21.7% to 82.6%) also improved from baseline to end of titration. At least one adverse event (AE) was reported by 78 patients (60.0%). The most common AEs considered possibly or probably related to study medication were dizziness, somnolence, and nausea (n = 10 [7.7%] each).DiscussionThese data indicate markedly improved satisfaction among patients receiving fentanyl sublingual spray relative to previous BTCP medications.
    Pain Practice 07/2014; · 2.18 Impact Factor
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    ABSTRACT: To examine the relationship between the dose of fentanyl sublingual spray needed to control breakthrough cancer pain (BTCP) and the dose of around-the-clock (ATC) opioid used to control background pain.
    Journal of opioid management 07/2014; 10(4):241-248.
  • Journal of Pain 04/2014; 15(4):S67. · 4.22 Impact Factor
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    ABSTRACT: A single-agent, extended-release formulation of hydrocodone (HC) has been developed for treatment of chronic moderate-to-severe pain. This study was designed to examine the safety and efficacy of HC extended release in opioid-experienced adults with moderate-to-severe chronic low back pain (CLBP). This multicenter, enriched enrollment, randomized withdrawal study comprised an open-label conversion/titration phase (≤6 weeks) followed by placebo-controlled, double-blind treatment (12 weeks). During the conversion/titration phase, subjects (N = 510) converted from their current opioid and were titrated to a stabilized dose of HC extended release (20-100 mg every 12 hours). During treatment, subjects (N = 151 per group) received HC extended release or placebo; rescue medication was permitted. The primary efficacy end point was mean change in average pain intensity from baseline to day 85. Response rates (30% pain improvement) and satisfaction (Subject Global Assessment of Medication) were assessed. Demographic and baseline characteristics were similar between groups. Mean ± SD change in average pain intensity score from baseline to day 85 was significantly lower in the HC extended-release treatment group vs placebo (0.48 ± 1.56 vs 0.96 ± 1.55; P = 0.008). Significantly more responders were in the treatment group (68% vs 31%; P < 0.001). Mean Subject Global Assessment of Medication scores increased significantly (0.8 ± 1.3 vs 0.0 ± 1.4; P < 0.0001), indicating greater satisfaction with HC extended release. The adverse event profile was consistent with other opioids. Extended-release HC is well tolerated and effective, without acetaminophen-associated risks of liver toxicity, for treatment of CLBP.
    Pain Medicine 02/2014; · 2.24 Impact Factor
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    ABSTRACT: The objective of this study was to identify best practices and provide guidance to clinicians to ensure safety and optimize intrathecal drug delivery for chronic intractable pain. Twelve experienced pain medicine practitioners-eight anesthesiologists, one neurosurgeon, one physiatrist, one clinical psychologist, and one advanced practice registered nurse-from the United States, Australia, and Europe gathered to identify and publish consensus on best practices in three areas related to safe intrathecal therapy for pain: safety and monitoring, patient and device management, and patient selection and trialing. Intrathecal drug delivery is a valuable alternative drug delivery system for many patients with severe chronic or end-of-life pain. While device-related complications (mostly with catheters) and surgical-site infections can occur, the main therapy-related safety issues associated with intrathecal drug delivery arise primarily with inadequate patient monitoring (e.g., respiratory depression), inflammatory mass (e.g., high doses and concentrations of opioids), wound healing, dosing errors (e.g., medication concentration and pump programming), pump fills or refills (e.g., pocket fills), and interaction with concomitant systemic medications (e.g., opioids and benzodiazepines). Many of the reported adverse events and complications of intrathecal drug delivery can be prevented by adequate clinician training, implementation of best practices, and experience. In adopting the therapy, patients must be apprised of its risks and benefits. Physicians and patients must partner to achieve both safety and effectiveness.
    Neuromodulation 01/2014; · 1.79 Impact Factor
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    ABSTRACT: To evaluate the long-term safety, tolerability, and effectiveness of single-entity extended-release hydrocodone in opioid-experienced subjects with moderate to severe chronic pain not receiving adequate pain relief or experiencing intolerable side effects from their current opioid. This multicenter, open-label study started with a conversion/titration phase (≤6 weeks) where subjects (n=638) were converted to individualized doses (range 20-300 mg) of extended-release hydrocodone dosed every 12 hours, followed by a 48-week maintenance phase (n=424). The primary objective (safety and tolerability) and the secondary objective (long-term efficacy as measured by change in average pain score; 0= no pain, 10= worst imaginable pain) were monitored throughout the study. Subjects were treated for a range of chronic pain etiologies, including osteoarthritis, low back pain, and neuropathic and musculoskeletal conditions. The mean hydrocodone equivalent dose at screening was 68.9±62.2 mg/day and increased to 139.5±81.7 mg/day at the start of the maintenance phase. Unlimited dose adjustments were permitted at the investigator's discretion during the maintenance phase, reflecting typical clinical practice. No unexpected safety issues were reported. Common adverse events during the conversion/titration and maintenance phases, respectively, were constipation (11.3% and 12.5%), nausea (10.7% and 9.9%), vomiting (4.1% and 9.7%), and somnolence (7.7% and 4.2%). Four deaths occurred during the study; all were considered unrelated to treatment. One subject died 13 months after the study ended. From the start to end of the conversion/titration phase, 84% of subjects had a clinically meaningful improvement in average pain score (≥30% improvement), and the mean average pain scores remained stable through the maintenance phase. This single-entity, extended-release formulation of hydrocodone was generally safe, well tolerated, and effective in reducing chronic pain for 48 weeks. This formulation provides a new option for patients experiencing chronic pain, especially those who are taking immediate-release hydrocodone and have concerns about liver toxicity due to acetaminophen.
    Journal of Pain Research 01/2014; 7:669-678.
  • Leonardo Kapural, Richard L Rauck
    The Clinical journal of pain 01/2014; 30(1):92. · 2.70 Impact Factor
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    Richard L Rauck
    Pain Practice 11/2013; · 2.18 Impact Factor
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    ABSTRACT: Oral gabapentin is approved as an anticonvulsant medication and to treat postherpetic neuralgia. Its nonopioid properties and presumed spinal site of analgesic action made the study on intrathecal gabapentin attractive to establish the minimum effective dose for a later, pivotal trial. The authors examined the safety and efficacy of intrathecal gabapentin in a randomized, blinded, placebo-controlled, multicenter trial in a heterogeneous cohort of candidates with chronic pain for intrathecal drug therapy. Patients (N = 170) were randomized to receive continuous intrathecal gabapentin (0 [placebo], 1, 6, or 30 mg/day) during 22 days of blinded treatment after implantation of a permanent drug delivery system. The highest dose, 30 mg/day, was selected to maintain a safety margin below the 100-mg/day dose that was explored in a phase 1 study. The authors found no statistically significant difference in the primary outcome measure, which was the numerical pain rating scale and response rate after 3 weeks, for any dose versus placebo. Physical functioning, quality of life, and emotional functioning also revealed no differences. Small, nonsignificant changes occurred in opioid medication use. The most frequent device-related adverse events were transient postimplant (lumbar puncture) headache, pain, and nausea. The most frequent gabapentin-related adverse events were nausea, somnolence, headache, dizziness, fatigue, and peripheral edema. Twenty-two days of intrathecal gabapentin did not demonstrate statistically significant or clinically meaningful analgesic effects. The study sponsor has no current plans for further studies. Drug-related adverse events were similar to those for oral gabapentin. Most device-related adverse events resulted from the implant surgery or anesthesia.
    Anesthesiology 09/2013; 119(3):675-86. · 6.17 Impact Factor
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    ABSTRACT: Present treatment methods are often unsatisfactory in reducing post-amputation pain. Peripheral nerve stimulation (PNS) could reduce the pain, but it is rarely used because present methods require invasive surgical access and precise placement of the leads in close proximity (≤2 mm) with the nerve. The present study investigated the feasibility of delivering PNS to patients with moderate-to-severe post-amputation pain in the lower extremity using a fine-wire lead placed percutaneously under ultrasound guidance a remote distance (0.5-3.0 cm) away from the sciatic and/or femoral nerves. Fourteen of the 16 subjects who completed in-clinic testing responded to stimulation, reported ≥75% paresthesia coverage, obtained clinically significant pain relief, and proceeded to a two-week home trial with a percutaneous PNS system. Two of the 14 responders had their leads removed early because of accidental dislodgement (N = 2), two had temporary discomfort near the lead (N = 2), and one had return of post-amputation pain despite stimulation (N = 1) and did not complete the home trial. The nine responders who completed the home trial reported reductions in their mean daily worst post-amputation pain (56 ± 26%, 56 ± 26%, N = 9), average residual limb pain (72 ± 28%, 42 ± 27%, N = 7), average phantom limb pain (81 ± 28%, 47 ± 48%, N = 7), residual limb pain interference (81 ± 27%, 53 ± 17%, N = 6), phantom limb pain interference (83 ± 31%, 56 ± 46%, N = 7), and Pain Disability Index (70 ± 38%, 55 ± 32%, N = 9) during the second week of stimulation and four weeks after the end of stimulation, respectively. All nine responders rated their change in quality of life as improved at the end of stimulation and at the end of the four-week follow-up period. Subjects reported minor decreases in the Beck Depression Inventory scores (43 ± 51%, 32 ± 57%, N = 9). Most subjects had no substantial changes other than minor decreases (N = 3) in pain medication. Achievement of significant pain relief and improvements in quality of life with a minimally invasive method of PNS holds promise for providing relief of post-amputation pain.
    Neuromodulation 08/2013; · 1.79 Impact Factor
  • Richard L Rauck
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    ABSTRACT: Most prescribed opioids exert their analgesic effects via activation of central μ-opioid receptors. However, μ-opioid receptors are also located in the gastrointestinal (GI) tract, and activation of these receptors by opioids can lead to GI-related adverse effects, in particular opioid-induced constipation (OIC). OIC has been associated with increased use of healthcare resources, increased healthcare costs, and decreased quality of life for patients. Nonpharmacologic (e.g., increased fiber uptake) and pharmacologic agents (e.g., laxatives) may be considered for the treatment and prevention of OIC. However, many interventions, such as laxatives alone, are generally insufficient to reverse OIC because they do not target the underlying cause of OIC, opioid activation of μ-opioid receptors in the GI tract. Therefore, there has been keen interest in antagonism of the μ-opioid receptor in the periphery to inhibit the effects of opioids in the GI tract. In this review, currently available pharmacologic therapies for the treatment and prevention of OIC are summarized briefly, with a primary focus on the administration of the peripheral μ-opioid receptor antagonist methylnaltrexone bromide in patients with OIC and advanced illness who are receiving palliative care. Also, clinical trial data of methylnaltrexone treatment in patients with OIC and other pain conditions (i.e., chronic noncancer pain and pain after orthopedic surgery) are reviewed. Data support that methylnaltrexone is efficacious for the treatment of OIC and has a favorable tolerability profile.
    Drugs 07/2013; · 4.13 Impact Factor
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    ABSTRACT: OBJECTIVE:: This study evaluated the long-term safety and tolerability of a gastroretentive formulation of gabapentin (G-GR) and its effect on weight gain in postherpetic neuralgia (PHN) patients participating in a 14-week, open-label extension to a 10-week double-blind study. METHODS:: Patients with PHN≥3 months, who had completed participation in a phase 3 randomized, double-blind, placebo-controlled study of the safety and efficacy of G-GR in PHN, who wished to continue treatment with G-GR, and who the investigator thought would benefit from study participation received G-GR 1800 mg as an asymmetrically divided dose (600 mg AM/1200 mg PM) for an additional 14 weeks. Analyses were performed on safety data from patients who received G-GR for 10 weeks in the randomized controlled study and who then received an additional 14 weeks of G-GR, asymmetrically dosed in the current study. Safety assessments included the incidence and severity of adverse events (AEs), the occurrence of serious AEs, changes in physical and neurological examination findings, clinical laboratory assessments, and changes in weight. RESULTS:: Eighty patients treated with G-GR in the randomized, controlled study participated in this 14-week extension study. The incidence of AEs commonly observed with gabapentin (dizziness, somnolence) was low and the frequency, intensity, and severity of AEs did not change with long-term treatment. The mean weight change from baseline in the randomized controlled study to the end of the extension study was +0.76 kg. Weight increase was reported as an AE for 2 (2.5%) patients. CONCLUSIONS:: Long-term treatment (up to 24 wk) with G-GR of 1800 mg was well tolerated and associated with little weight gain (<1 kg) in patients with PHN. No new safety issues emerged with G-GR long-term treatment.
    The Clinical journal of pain 01/2013; · 2.70 Impact Factor
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    ABSTRACT: OBJECTIVE.: The aim was to compare the efficacy of intradiscal biacuplasty (IDB) with that of placebo treatment for discogenic low back pain. DESIGN.: This is a randomized, placebo-controlled trial. Subjects were randomized on a 1:1 basis to IDB and sham groups. Follow-ups were conducted at 1, 3, and 6 months. Subjects and coordinators were blinded to randomization until 6 months. Of the 1,894 subjects screened, 64 subjects were enrolled, and 59 were treated: 29 randomized to IDB and 30 to sham. All subjects had a history of chronic low back pain for longer than 6 months. INTERVENTIONS.: Two cooled radiofrequency (RF) electrodes placed in a bipolar manner in affected discs to lesion the nociceptive fibers of the annulus fibrosus. The sham procedure was identical to the active treatment except that probes were not directly inserted into the disc space, and RF energy was not actively delivered. RESULTS.: The principal outcome measures were physical function, pain, disability, and opioid usage. Patients in the IDB group exhibited statistically significant improvements in physical function (P = 0.029), pain (P = 0.006), and disability (P = 0.037) at 6-month follow-up as compared to patients who received sham treatment. Treatment patients reported a reduction of 16 mg daily intake of opioids at 6 months; however, the results were not statistically different from sham patients. CONCLUSIONS.: The results suggest that the clinical benefits observed in this study are the result of non-placebo treatment effects afforded by IDB. IDB should be recommended to select the patients with chronic discogenic low back pain. (Clinicaltrials.gov number, NCT00750191.).
    Pain Medicine 12/2012; · 2.24 Impact Factor
  • Richard Rauck, Michael Busch, Thomas Marriott
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    ABSTRACT: OBJECTIVE: Evaluate potential usefulness of a heated lidocaine/tetracaine topical patch for treatment for pain associated with myofascial trigger points (MTPs). BACKGROUND: Depth and duration of analgesia when patch is used as indicated, on intact skin to provide local dermal analgesia for superficial venous access and dermatologic procedures, suggest utility in relief of MTP-associated pain. METHODS: In this open-label, single-center outpatient pilot study, patients with ≥ 1-month history of pain associated with up to 3 MTPs and average pain intensity ≥ 4 on 11-point scale applied 1 patch to each MTP for 4 hours twice daily for 2 weeks, followed by 2 weeks with no treatment. Patients continued prescribed analgesic dosing regimens. RESULTS: Twenty patients enrolled; 17 completed the study. At baseline, mean ± SD average pain intensity was 6.3 ± 1.56. This decreased by 33% to 4.5 ± 2.31 (N = 20) at the end of treatment; 40% of patients had clinically significant (≥ 30%) decrease, and 25% had substantial (≥ 50%) decrease. Pain interference with general activity, mood, normal work, and enjoyment of life decreased by ≥ 50% in 35% of patients; and with walking, sleep, and relationship by ≥ 50% in 50% of patients (N = 20). Worst trigger point sensitivity improved in 45% of patients; 75% were satisfied or very satisfied with treatment; none required rescue medication. Two weeks after stopping treatment, average pain intensity was 5.0 ± 2.04; treatment benefit was maintained in 8 (40%) patients. The most common adverse event was erythema. CONCLUSION: The heated lidocaine/tetracaine patch has potential utility as a noninvasive pharmacologic approach for managing MTP pain. Further studies are warranted.
    Pain Practice 12/2012; · 2.18 Impact Factor
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    ABSTRACT: BACKGROUND: Gabapentin enacarbil (GEn), a transported prodrug of gabapentin, provides sustained, dose-proportional gabapentin exposure. The purpose of this study was to investigate the dose response of GEn to select the optimal dose(s) for clinical use in subsequent diabetic peripheral neuropathy (DPN) trials. METHODS: This was a multicenter, randomized, double-blind, double-dummy, parallel group, placebo-controlled trial with a study duration of approximately 20 weeks (Clinicaltrials.gov database, Identifier ! NCT00643760). Pregabalin (PGB) (Lyrica(®) ; Pfizer Inc.) was used as an active control to provide assay sensitivity of the trial. A total of 421 adult subjects with DPN were randomized in a ratio of 2:1:1:1:2 to receive oral GEn 3,600 mg/day, GEn 2,400 mg/day, GEn 1,200 mg/day, PGB 300 mg/day, or matching placebo, respectively. The primary efficacy endpoint was change from baseline to end of maintenance treatment with respect to the mean 24-hour average pain intensity score based on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS). Safety and tolerability assessments included treatment-emergent adverse events (TEAEs), laboratory evaluations, vital signs, electrocardiograms (ECG), neurological examination, and pedal edema. RESULTS: The adjusted mean difference vs. placebo at the end of maintenance treatment with respect to the mean 24-hour average PI-NRS pain intensity score for GEn 1,200 mg (-0.35; [95% CI: -1.02, 0.31]; P = 0.295), GEn 2,400 mg (-0.02; [95% CI: -0.71, 0.66]; P = 0.946), and GEn 3,600 mg (-0.55; [95% CI: -1.10, 0.01]; P = 0.105) was not statistically significant. The active control, PGB (300 mg/day), did not differentiate from placebo. CONCLUSION: Overall, none of the GEn treatment groups differentiated from placebo. Analyses of the secondary endpoints showed comparable results across treatment groups. However, the majority of the endpoints, including all of the pain endpoints, showed the largest numerical treatment difference was between GEn 3,600 mg and placebo. The active control, PGB (300 mg/day), did not differentiate from placebo.
    Pain Practice 11/2012; · 2.18 Impact Factor
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    ABSTRACT: CONTEXT: Treatment options for postherpetic neuralgia (PHN), a complication of herpes zoster, are commonly unsatisfactory and associated with adverse events. OBJECTIVES: To evaluate the efficacy, onset of pain relief, and safety of gastroretentive gabapentin (G-GR) in patients with PHN. METHODS: In two placebo-controlled studies, 357 patients with PHN were randomized to 1800mg G-GR and 364 patients were randomized to placebo taken with the evening meal. Patients underwent a two week titration, eight weeks of stable dosing, and one week of tapering. Efficacy assessments included change in average daily pain (ADP) score from baseline to Week 10, time to onset of pain relief, the proportion of patients feeling improved using the Patient Global Impression of Change, and the proportion of responders (≥30% pain reduction). RESULTS: At Week 10, patients randomized to G-GR reported greater reductions in ADP score compared with placebo (-37.0% vs. -29.1; P=0.0025). More G-GR patients felt improved compared with placebo (44% vs. 33%; P=0.003) and responded to treatment (54% vs. 41%; P=0.001). As early as Day 2, greater pain reductions were observed for the G-GR group compared with the placebo group (-6.6% vs. -1.6%; P=0.0017). The median time to a one point or greater reduction in ADP score was four days for G-GR and six days for placebo (P<0.0001). The most frequently reported adverse events were dizziness (G-GR, 11%; placebo, 2%) and somnolence (G-GR, 5%; placebo, 3%). CONCLUSION: PHN pain reduction after G-GR treatment can be observed as early as the second day of dosing and continues for at least 10 weeks.
    Journal of pain and symptom management 11/2012; · 2.42 Impact Factor
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    ABSTRACT: OBJECTIVES: The Prometra® Programmable Pump System (Flowonix Medical, Inc., Mt. Olive, NJ, USA) is designed for continuous intrathecal administration of morphine sulfate to treat chronic intractable pain. As a follow-up to a previous report on acute six-month data, this study evaluated the efficacy of treatment at one year and the accuracy of drug delivery throughout the study (average of 2.5 years, range 0-3.6 years). METHODS: Accuracy of drug delivery was determined as the ratio of delivered-to-programmed drug volume at scheduled refill visits (monthly for the first six months and every three months thereafter). Efficacy was assessed at 12 months using the visual analog and numeric rating scales and the Oswestry Disability Index. Safety was assessed by documenting adverse events and device complications throughout the study. RESULTS: The mean accuracy of the Prometra pump was 97.9% and was comparable to the reported accuracy at one to six months (97.1%). After 12 months, 68% of the remaining subjects reported improvement in disability scores from baseline and more than 75% of the remaining subjects reported decreases in pain from baseline. The incidence rates of adverse events and device complications were similar to previous reports for this therapy. CONCLUSIONS: The Prometra pump demonstrated accurate drug delivery throughout the study and provides an effective and safe means for intrathecal administration of morphine sulfate for treatment of chronic intractable pain.
    Neuromodulation 10/2012; · 1.79 Impact Factor

Publication Stats

2k Citations
344.59 Total Impact Points

Institutions

  • 2008–2014
    • North Carolina Clinical Research
      Raleigh, North Carolina, United States
    • Winston-Salem State University
      Winston-Salem, North Carolina, United States
  • 2006–2014
    • Carolinas Pain Institute
      • Center for Clinical Research
      Winston-Salem, North Carolina, United States
  • 1996–2011
    • Wake Forest University
      • Department of Anesthesiology
      Winston-Salem, North Carolina, United States
  • 1998
    • Wake Forest School of Medicine
      • Department of Anesthesiology
      Winston-Salem, NC, United States