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Balance chiropractic therapy for cervical spondylotic radiculopathy: study protocol for a randomized controlled trial.

ABSTRACT: Cervical spondylosis is a very common disorder and cervical spondylotic radiculopathy (CSR) is the most common form of spinal degenerative disease. Its clinical manifestations focus on pain and numbness of the neck and arm as well as restricted movement of the neck, which greatly affect the patient's life and work. The orthopedic of traditional Chinese medicine (TCM) theory holds that the basic pathologic change in spinal degenerative diseases is the imbalance between the dynamic system and the static system of the cervical spine. Based on this theory, some Chinese physicians have developed a balance chiropractic therapy (BCT) to treat CSR, which has been clinically examined for more than 50 years to effectively cure CSR. The purpose of this study is to evaluate the therapeutic effect and safety of BCT on CSR and to investigate the mechanism by which the efficacy is achieved.We propose a multicenter, parallel-group, randomized controlled trial to evaluate the efficacy and safety of BCT for CSR. Participants aged 18 to 65 years, who are in conformity with the diagnostic criteria of CSR and whose pain score on a Visual Analog Scale (VAS) is more than 4 points and less than 8 points, will be included and randomly allocated into two groups: a treatment group and a control group. Participants in the treatment group will be treated with BCT, while the control group will receive traction therapy (TT). The primary outcome is pain severity (measured with a VAS). Secondary outcomes will include cervical curvature (measured by the Borden Index), a composite of functional status (measured by the Neck Disability Index, NDI), patient health status (evaluated by the SF-36 health survey) and adverse events (AEs) as reported in the trial.If BCT can relieve neck pain without adverse effects, it may be a novel strategy for the treatment of CSR. Furthermore, the mechanism of BCT for CSR will be partially elucidated.Clinical Trials.gov Identifier: NCT02705131 . Registered on 9 March 2016.

SUBMITTER: Yang F

PROVIDER: S-EPMC5075147 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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Balance chiropractic therapy for cervical spondylotic radiculopathy: study protocol for a randomized controlled trial.

Yang Feng F Li Wen-Xiong WX Liu Zhu Z Liu Li L

Trials 20161022 1

<h4>Background</h4>Cervical spondylosis is a very common disorder and cervical spondylotic radiculopathy (CSR) is the most common form of spinal degenerative disease. Its clinical manifestations focus on pain and numbness of the neck and arm as well as restricted movement of the neck, which greatly affect the patient's life and work. The orthopedic of traditional Chinese medicine (TCM) theory holds that the basic pathologic change in spinal degenerative diseases is the imbalance between the dyna ...[more]

PMID: 27770801

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Project description:IntroductionCervical spondylotic radiculopathy (CSR) is the most common pattern of cervical spondylosis, which is a serious and common degenerative disease. Both acupotomy and acupuncture have been widely used clinically to treat CSR in China with satisfied efficacy. However, there is no systematic review comparing the effectiveness of these two therapies. The aim of this study is to compare the therapeutic efficacy and safety between acupotomy and acupuncture for patients with CSR to provide evidence for clinical practice.Methods and analysisThe following electronic databases will be searched: Web of Science, PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure , China Biology Medicine disc, Wanfang Database and Chinese Scientific Journal Database (VIP). The randomised controlled trials of acupotomy versus acupuncture with/without additional treatment for CSR will be searched in the databases from their inception to December 2018 by two researchers independently. Visual analogue scale, symptom score and neck disability index will be assessed as the primary outcomes. The total effective rate, curative rate, adverse events and amount of rescue medication used will be assessed as the secondary outcomes. The Review Manager 5.3 will be used for meta-analysis and the evidence level will be assessed by using the method for Grading of Recommendations Assessment, Development and Evaluation. Continuous outcomes will be presented as the weighted mean difference or standardised mean difference with 95% CI, whereas dichotomous data will be expressed as relative risk with 95%?CI. If the included studies have existing heterogeneity (p<0.05), then a random-effects model will be used. Otherwise, we will calculate using a fixed-effects model.Ethics and disseminationEthical approval is not required because no primary data are collected. This review will be published in a peer-reviewed journal and will be presented at an international academic conference for dissemination.Prospero registration numberCRD42019117348.

Project description:Sagittal cervical alignment is a clinically related feature in patients suffering from chronic cervical spondylotic radiculopathy (CSR). We designed this randomized trial to explore the effects of cervical lordosis (CL) correction in thirty chronic lower CSR patients with CL < 20°. Patients were assigned randomly into two equal groups, study (SG) and control (CG). Both groups received neck stretching and exercises and infrared radiation; additionally, the SG received cervical extension traction. Treatments were applied 3× per week for 10 weeks after which groups were followed for 3 months and 2 years. The amplitude of dermatomal somatosensory evoked potentials (DSSEPS), CL C2−C7, and pain scales (NRS) were measured. The SG had an increase in CL post-treatment (p < 0.0001), this was maintained at 3 months and 2 years. No statistical improvement in CL was found for the CG. A significant reduction in NRS for SG after 10 weeks of treatment with non-significant loss of change at 3 months and continued improvement at 2 years was found. CG had less significant improvement in post-treatment NRS; the 3-month and 2-year measures revealed significant worsening in NRS. An inverse linear correlation between increased CL and NRS was found (r = −0.49; p = 0.005) for both groups initially and maintained in SG at the final 2-year follow-up (r = −0.6; p = 0.01). At 10 weeks, we found significant improvements in DSSEPS for both groups (p < 0.0001). We identified a linear correlation between initial DSSEPs and CL for both groups (p < 0.0001), maintained only in the SG at the final follow-up for all levels (p < 0.0001). Improved CL in the SG correlated with significant improvements in nerve root function and pain rating in patients with CSR at short and long-term follow-up. These observed effects indicate that clinicians involved in the treatment of patients with symptoms of cervical degenerative disorders should add sagittal curve correction to their armamentarium of rehabilitation procedures for relevant patient populations.

Project description:Neck pain is a common symptom in most patients suffering from cervical radiculopathy. However, some conservative treatments are limited by their modest effectiveness. On the other hand, surgical intervention for cervical disc disorders is indicated when symptoms are refractory to conservative treatments and neurological symptoms are progressive. Many patients use complementary and alternative medicine, including traditional Chinese medicine, to address their symptoms. The purpose of the present study is to examine the efficacy and safety of Qishe Pill, a compound traditional Chinese herbal medicine, for neck pain in patients with cervical radiculopathy.A multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of the Qishe Pill is proposed. The study will include 240 patients from five sites across China and diagnosed with cervical radiculopathy, according to the following inclusion criteria: age 18 to 65 with pain or stiffness in the neck for at least 2 weeks (neck disability index score 25 or more) and accompanying arm pain that radiates distally from the elbow. Qualified participants will be randomly allocated into two groups: Qishe Pill group and placebo group. The prescription of the trial medications (Qishe Pill/placebo) are 3.75 g each twice a day for 28 consecutive days. The primary outcome is pain severity. Secondary outcomes are functional status, patient satisfaction, and adverse events as reported in the trial.Qishe Pill is composed of processed Radix Astragali, Muscone, Szechuan Lovage Rhizome, Radix Stephaniae Tetrandrae, Ovientvine, and Calculus Bovis Artifactus. According to modern research and preparation standards, Qishe Pill is developed to improve on the various symptoms of cervical radiculopathy, especially for neck pain. As it has a potential benefit in treating patients with neck pain, we designed a double-blind, prospective, randomized-controlled trial and would like to publish the results and conclusions later. If Qishe Pill can alleviate neck pain without adverse effects, it may be a unique strategy for the treatment of cervical radiculopathy.This study is registered at ClinicalTrials.gov, NCT01274936.

Project description:BackgroundA research gap exists for optimal management of cervical radiculopathy in the first 12 weeks and short term natural history of the condition is somewhat unclear, although thought to be favourable. The primary aim of this assessor blinded, superiority, 2 parallel group randomised controlled trial is to investigate the effects of a 4 week physiotherapy programme (6-8 sessions) of manual therapy, exercise and upper limb neural unloading tape, compared to a control of weekly phone advice; on disability, pain and selected biopsychosocial measures, in acute and sub-acute cervical radiculopathy patients. A secondary aim is to identify whether any baseline variables, symptom duration or group allocation can predict outcome.MethodsParticipants are recruited from GP referrals in an urban setting, from a neurosurgery non-urgent waiting list and from self-referral through Facebook advertising. Eligible participants (n = 64) are diagnosed with radiculopathy based on a clinical prediction rule and must have symptoms of unilateral, single level, radiculopathy for between 2 and 12 weeks, without having yet received physiotherapy. Random 1:1 group allocation (using variable block sizes), allocation concealment, blinded assessment and intention to treat analysis are being employed. Treatment is provided by clinical specialist physiotherapists in primary and secondary care settings. Outcomes are measured at baseline, 4 (primary endpoint) and 12 weeks. Participants' report of pain, disability and their rating of recovery is also recorded by telephone interview at 6 months. Statistical analysis of between group differences will be performed with ANOVAs and MANOVAs, and multivariable regression analysis will be undertaken to explore predictor variables. Ethical approval for this study has been received from the Beaumont Hospital and Irish College of General Practitioners Research Ethics Committees. The trial is registered at ClinicalTrials.gov (NCT02449200).DiscussionAn internal pilot study to test retention and recruitment strategies led to trial expansion and this is now a multi centre trial involving 5 clinical sites.Trial registrationNCT02449200 . Registered 20/05/15.

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Balance chiropractic therapy for cervical spondylotic radiculopathy: study protocol for a randomized controlled trial.

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Balance chiropractic therapy for cervical spondylotic radiculopathy: study protocol for a randomized controlled trial.

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