Project

Spine corrective care RCT’s

Goal: To investigate the conservative care effects of true spine correction of abnormal Sagittal plane profiles. By comparing standard spine rehabilitation care (SMT, Massage, Functional Based Exercise, etc.) to standard care plus care known to truly correct the structure of the spine (structural rehabilitation care), we can test whether or not interventional care specifically derived from abnormal radiographic findings makes a difference to patient relevant outcomes. We plan to investigate corrective care vs. standard care outcomes for a variety of common patient chronic conditions: back pain, leg pain, neck pain, headaches, arm pain, dizziness, etc...

Date: 30 December 2004 - 30 December 2024

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Deed Eric Harrison
added 2 research items
Abstract: The aim of this study was to investigate the feasibility and effect of a multimodal pro-gram for the management of chronic nonspecific neck pain CNSNP with the addition of a 3D adjustable posture corrective orthotic (PCO), with a focus on patient recruitment and retention. This report describes a prospective, randomized controlled pilot study with twenty-four participants with CNSNP and definite 3D postural deviations who were randomly assigned to control and study groups. Both groups received the same multimodal program; additionally, the study group received a 3D PCO to perform mirror image® therapy for 20–30 min while the patient was walking on a treadmill 2–3 times per week for 10 weeks. Primary outcomes included feasibility, recruitment, adherence, safety, and sample size calculation. Secondary outcomes included neck pain intensity by numeric pain rating scale (NPRS), neck disability index (NDI), active cervical ROM, and 3D posture parameters of the head in relation to the thoracic region. Measures were assessed at baseline and after 10 weeks of intervention. Overall, 54 participants were screened for eligibility, and 24 (100%) were enrolled for study participation. Three participants (12.5%) were lost to reassessment before finishing 10 weeks of treatment. The between-group mean differences in change scores indicated greater improvements in the study group receiving the new PCO intervention. Using an effect size of 0.797, α > 0.05, β = 80% between-group improvements for NDI identified that 42 participants were required for a full-scale RCT. This pilot study demonstrated the feasibility of recruitment, compliance, and safety for the treatment of CNSNP using a 3D PCO to a multimodal program to positively affect CNSNP management. Keywords: neck pain; orthotic; mirror image® therapy; reverse posture training
Forward head posture (FHP) is a common postural displacement that is significantly associated with neck pain, with higher risks of having neck pain in female and older populations. This study investigated the effect of two different forward head posture (FHP) interventions in elderly participants with poor posture and non-specific neck pain. Sixty-six elderly participants with a craniovertebral angle (CVA) < 50° were randomized into either a Chiropractic Biophyics® (CBP®) or a standardized exercise based FHP correction group (Standard Group). Both groups were treated for 18 sessions over a 6-week period. A 3-month post-treatment follow-up was also assessed with no further interventions. The CBP group received a mirror image® exercise and a Denneroll™ cervical traction orthotic (DCTO); the standard group performed a protocol of commonly used stretching and strengthening exercises for the neck. Both groups received 30 min of their respective interventions per session. The primary outcome was the CVA, with secondary outcomes including pain intensity, Berg balance score (BBS), head repositioning accuracy (HRA), and cervical range of motion (CROM). After 18 sessions (6 weeks later), the CBP group had statistically significant improvement in the CVA (p < 0.001), whereas the standard group did not. In contrast, both groups showed improved functional measurements on the BBS and HRA as well as improved pain intensity. However, at the 3-month follow-up (with no further treatment), there were statistically significant differences favoring the CBP group for all outcomes (p < 0.001). The differences in the between group outcomes at the 3-month follow-up indicated that the improved outcomes were maintained in the CBP group, while the standard group experienced regression of the initially improved outcomes at 6 weeks. It is suggested that the improvement in the postural CVA (in the CBP group but not in the standard group) is the driver of superior and maintained pain and functional outcomes.
Deed Eric Harrison
added 5 research items
[Purpose] To systematically review controlled trial evidence for the use of lumbar extension traction by Chiropractic BioPhysics® methods for the purpose of increasing lumbar lordosis in those with hypolordosis and low back disorders. [Methods] Literature searches were performed in Pubmed, PEDro, CINAHL, Cochrane, and ICL databases. Search terms included iterations related to the lumbar spine, low back pain and extension traction rehabilitation. [Results] Four articles detailing 2 randomized and 1 non-randomized trial were located. Trials demonstrated increases in radiographic measured lordosis of 7–11°, over 10–12 weeks, after 30–36 treatment sessions. Randomized trials demonstrated traction treated groups mostly maintained lordosis correction, pain relief, and disability after 6-months follow-up. The non-randomized trial showed lordosis and pain intensity were maintained with periodic maintenance care for 1.5 years. Importantly, control/comparison groups had no increase in lumbar lordosis. Randomized trials showed comparison groups receiving physiotherapy-less the traction, had temporary pain reduction during treatment that regressed towards baseline levels as early as 3-months after treatment. [Conclusion] Limited but good quality evidence substantiates that the use of extension traction methods in rehabilitation programs definitively increases lumbar hypolordosis. Preliminarily, these studies indicate these methods provide longer-term relief to patients with low back disorders versus conventional rehabilitation approaches tested.
Low back and neck pain disorders are among the leading causes for work loss, suffering, and health care expenditures throughout the industrialized world. It has been extensively demonstrated that sagittal plane alignment of the cervical and lumbar spines impacts human health and well-being. Today there are reliable and predictable means through the application of extension spinal traction as part of comprehensive rehabilitation programs to restore the natural curvatures of the spine. High-quality evidence points to Chiropractic BioPhysics® (CBP®) methods offering superior long-term outcomes for treating patients with various craniocer-vical and lumbosacral disorders. CBP technique is a full spine and posture rehabilitation approach that incorporates mirror image® exercises, spinal and postural adjustments, and unique traction applications in the restoration of normal/ideal spinal alignment. Recent randomized controlled trials using CBP's unique extension traction methods in conjunction with various conventional physiotherapeutic methods have demonstrated those who restore normal lordosis (cervical or lumbar) get symptomatic relief that lasts up to 2 years after treatment. Comparative groups receiving various 'cookie-cutter' conventional treatments experience only temporary symptomatic relief that regresses as early as 3 months after treatment. The economic impact/benefit of CBPs newer sagittal spine rehabilitation treatments demand continued attention from clinicians and researchers alike.
Deed Eric Harrison
added 2 research items
A randomized controlled study with a six-month follow-up was conducted to investigate the effects of sagittal head posture correction on 3D spinal posture parameters, back and leg pain, disability, and S1 nerve root function in patients with chronic discogenic lumbosacral radiculopathy (CDLR). Participants included 80 (35 female) patients between 40 and 55 years experiencing CDLR with a definite hypolordotic cervical spine and forward head posture (FHP) and were randomly assigned a comparative treatment control group and a study group. Both groups received TENS therapy and hot packs, additionally, the study group received the Denneroll cervical traction orthotic. Interventions were applied at a frequency of 3 x per week for 10 weeks and groups were followed for an additional 6-months. Radiographic measures included cervical lordosis (CL) from C2–C7 and FHP; postural measurements included: lumbar lordosis, thoracic kyphosis, trunk inclination, lateral deviation, trunk imbalance, surface rotation, and pelvic inclination. Leg and back pain scores, Oswestry Disability Index (ODI), and H-reflex latency and amplitude were measured. Statistically significant differences between the groups at 10 weeks were found: for all postural measures, CL (p = 0.001), AHT (p = 0.002), H-reflex amplitude (p = 0.007) and latency (p = 0.001). No significant difference for back pain (p = 0.2), leg pain (p = 0.1) and ODI (p = 0.6) at 10 weeks were identified. Only the study group’s improvements were maintained at the 6-month follow up while the control groups values regressed back to baseline. At the 6-month follow-up, it was identified in the study group that improved cervical lordosis and reduction of FHP were found to have a positive impact on 3D posture parameters, leg and back pain scores, ODI, and H-reflex latency and amplitude.
This study investigates thoracic hyper kyphosis (THK) rehabilitation using the Denneroll™ thoracic traction orthosis (DTTO). Eighty participants, with chronic non-specific neck pain (CNSNP) and THK were randomly assigned to the control or intervention group (IG). Both groups received the multimodal program; IG received the DTTO. Outcomes included formetric thoracic kyphotic angle ICT—ITL, neck pain and disability (NDI), head repositioning accuracy (HRA), smooth pursuit neck torsion test (SPNT) and overall stability index (OSI). Measures were assessed at baseline, after 30 treatment sessions over the course of 10 weeks, and 1-year after cessation of treatment. After 10 weeks, the IG improved more in neck pain intensity (p < 0.0001) and NDI (p < 0.001). No differences were found for SPNT (p = 0.48) and left-sided HRA (p = 0.3). IG improved greater for OSI (p = 0.047) and right sided HRA (p = 0.02). Only the IG improved in THK (p < 0.001). At 1-year follow-up, a regression back to baseline values for the control group was found for pain and disability such that all outcomes favored improvement in the IG receiving the DTTO; all outcomes (p < 0.001). The addition of the DTTO to a multimodal program positively affected CNSNP outcomes at both the short and 1-year follow-up.
Deed Eric Harrison
added 7 research items
Abstract Objective To investigate the immediate and 1-year effects of a multimodal program, with cervical lordosis and anterior head translation (AHT) rehabilitation, on the severity of pain, disability, peripheral and central nervous system function in patients with discogenic cervical radiculopathy (DCR). Design A randomized controlled study with a 1-year and 10-week follow-up. Setting University research laboratory. Participants 40 (27 males) patients with chronic DCR, a defined hypolordotic cervical spine and AHT posture were randomly assigned to the control (43.9 ± 6.2 years of age) or an intervention group (41.5 ± 3.7 years of age). Interventions Both groups received the multimodal program; additionally, the intervention group received the denneroll cervical traction device. Main Outcome Measures AHT, cervical lordosis, arm pain, neck pain and disability (NDI), dermatomal somatosensory evoked potentials (DSSEP’s) and central somatosensory conduction time (N13-N20). Measures were assessed at three time intervals: baseline, 10 weeks, and 1 year follow up. Results After 10 weeks of treatment, between group analysis, showed equal improvements for both the intervention and control groups in arm pain intensity (p=0.4), neck pain intensity (p=0.6), and latency of DSSEP’s (p=0.6). However, also at 10 weeks, there were significant differences between groups favoring the intervention group for cervical lordosis (p˂0.0005), AHT (p˂0.0005), amplitude of DSSEP’s (p˂0.0005), N13-N20 (p˂0.0005), and NDI (p˂0.0005). Whereas, at the 1 year follow-up, between group analysis identified a regression back to baseline values for the control group. Thus, all variables were significantly different favoring the intervention group at 1-year follow up period: cervical lordosis (P˂0.0005), AHT (P˂0.0005), latency and amplitude of DSSEP’s (P˂0.0005), N13-N20 (P˂0.0005), severity of neck and arm pain, and NDI (P˂0.0005) in favor of the denneroll group. Conclusion The addition of the denneroll cervical orthotic to a multimodal program positively affected DCR outcomes at long term follow up. We speculate the improved cervical lordosis and reduced AHT contributed to our findings. Key Words: Randomized controlled trial, cervical lordosis, disc herniation, radiculopathy, traction
Increasingly, there is more attention being directed to the role that full spine sagittal alignment plays in causing or exacerbating a variety of musculoskeletal disorders. Similarly, spinal displacements, termed subluxation, are thought to cause dysfunctions in the entire neuromusculoskeletal system that may lead to altered neurophysiological function, abnormal sensorimotor control, and altered autonomic nervous system function. Abnormalities in neutral upright spine alignment (sagittal translation or flexion deformities) are known to increase mechanical loads (stresses and strains) on the central nervous system. These increased mechanical loads may subtly or overtly impair neurophysiological function as measured with evoked potentials in terms of latency and amplitudes of potentials. Proprioceptive afferentation from spine ligaments, muscles and discs are considered a major component of sensorimotor control. The voluminous mechanoreceptors in spinal muscles, ligaments, and discs plays an intimate role, providing the necessary neurophysiological input in a feed forward and feedback system for sensorimotor control via connections to the vestibular, visual and central nervous systems. Of particular interest, a network of neurophysiological connections between spine mechanoreceptors and the sympathetic nervous system has been documented. This chapter explores the hypothesis and evidence that restoring normal posture and spine alignment has important influences on neurophysiology, sensorimotor control and autonomic nervous system functionality. There is limited but high-quality research identifying that sagittal spine alignment restoration plays an important role in improving neurophysiology, sensorimotor control, and autonomic nervous system function. Accordingly, in the current chapter, we review this work in hopes of stimulating further investigations into structural rehabilitation of the spine and posture.
Background: Cervicogenic dizziness is a disabling condition commonly associated with cervical dysfunction. Although the growing interest with the importance of normal sagittal configuration of cervical spine, the missing component in the management of cervicogenic dizziness might be altered structural alignment of the cervical spinal region itself. Aim: To investigate the immediate and long-term effects of a 1-year multimodal program, with the addition of cervical lordosis restoration and anterior head translation (AHT) correction, on the severity of dizziness, disability, cervicocephalic kinesthetic sensibility, and cervical pain in patients with cervicogenic dizziness. Design: A randomized controlled study with a 1-year and 10-week follow-up. Setting: University research laboratory. Population: 72 (25 female) patients between 40 and 55 years with cervicogenic dizziness, a definite hypolordotic cervical spine and AHT posture were randomly assigned to the control or an experimental group. Methods: Both groups received the multimodal program; additionally, the experimental group received the dennerollTM cervical traction. Outcome measures included AHT distance, cervical lordosis, dizziness handicap inventory (DHI), severity of dizziness, dizziness frequency, head repositioning accuracy (HRA) and cervical pain. Measures were assessed at three time intervals: baseline, 10 weeks, and 1 year after the 10 week follow up. Results: Significant group × time effects at both the 10 week post treatment and the 1-year follow up were identified favoring the experimental group for measures of cervical lordosis (P<0.0005) and anterior head translation (P<0.0005). At 10 weeks, the between group analysis showed equal improvements in dizziness outcome measures, pain intensity, and HRA; DHI scale (P=0.5), severity of dizziness (P=0.2), dizziness frequency (P= .09), HRA (P= ,1) and neck pain (P=0.3),. At the 1 year follow-up, the between group analysis identified statistically significant differences for all of the measured variables including anterior head translation (2.4 cm [-2.3, - 1.8], P<.0005), cervical lordosis (-14.4° [-11.6, -8.3], P<.0005), dizziness handicap inventory (29.9 [-34.4, -29.9], P<.0005), severity of dizziness (5.4 [-5.9, -4.9], P<.0005), dizziness frequency (2.6 [-3.1, -2.5], P<.0005) ,HRA for RT rotation ( 2.8[-3.9 -3.3], P<.005) ,HRA for LT rotation( 3.1 [-3.5 -3.4, P<.0005] , neck pain (4.97 [-5.3, -4.3], P<.0005); indicating greater improvements in the experimental group. Conclusion: The addition of dennerollTM cervical extension traction to a multimodal program positively affected pain, cervicocephalic kinesthetic sensibility, dizziness management outcomes at long term follow up. Clinical rehabilitation impact: Appropriate physical therapy rehabilitation for cervicogenic dizziness should include structural rehabilitation of the cervical spine (lordosis and head posture correction), as it might to lead greater and longer lasting improved function.
Deed Eric Harrison
added a project goal
To investigate the conservative care effects of true spine correction of abnormal Sagittal plane profiles. By comparing standard spine rehabilitation care (SMT, Massage, Functional Based Exercise, etc.) to standard care plus care known to truly correct the structure of the spine (structural rehabilitation care), we can test whether or not interventional care specifically derived from abnormal radiographic findings makes a difference to patient relevant outcomes. We plan to investigate corrective care vs. standard care outcomes for a variety of common patient chronic conditions: back pain, leg pain, neck pain, headaches, arm pain, dizziness, etc...
 
Deed Eric Harrison
added a research item
Background To investigate the feasibility and effect of a multimodal program for improving chronic cervicogenic headache (CGH) via the addition of sagittal cervical spine alignment correction. Design Pilot, parallel-group, randomized controlled trial. Participants 60 patients with CGH, straightening of the cervical lordosis, and forward head posture (FHP) were randomly assigned using permuted-block randomization either to a control (n = 30) or an experimental group (n = 30). Interventions Subjects in both groups received a multimodal program where the denneroll cervical spine extension traction orthotic was added to the experimental group only. Feasibility was assessed through recruitment rate, compliance rate, adherence rate, safety, and global satisfaction in addition to clinical outcome measures: FHP distance, cervical lordosis, headache frequency, headache disability inventory (HDI), headache impact test-6 (HIT-6), and daily defined dose (DDD). Evaluations were performed at: baseline, 10 weeks, 1 year follow up, and 2-year follow up. The assessor was blind to group allocation for all measured outcomes. Results The recruitment rate was 60%, 78 % out of them completed the entire study. The recruited participants complied with 98% of the required visits. No adverse events were recorded and greater overall satisfaction with the interventions was reported. Greater improvements were found for the experimental group's cervical lordosis (f = 259.9, P< < .001) and FHP (f = 142.5, P< < .001). At 10 weeks, both groups showed equal improvements in CGH outcomes: headache frequency (P = 0.07), HDI (P = 0.07), HIT-6 (P = .2), and DDD (P = .3). In contrast, at the 1-year and 2-year follow up, between group differences were found for all CGH outcomes, P < .00, indicating greater improvement in the experimental group. Conclusion The results indicated feasibility for recruitment rate, compliance rate, exercise session adherence, safety, and global satisfaction. At 1-year and 2-year follow-up, the addition of the denneroll orthotic device revealed positive influence on CGH management outcomes. Trial registration The trial was retrospectively registered with the Pan African Clinical Trial Registry (PACTR201605001650300).