Dataset Information

Shi-style cervical manipulations for cervical radiculopathy: A multicenter randomized-controlled clinical trial.

ABSTRACT:

Background

There is a lack of high-quality evidence supporting the use of manipulation therapy for patients with cervical radiculopathy (CR). This study aimed to evaluate the effectiveness of Shi-style cervical manipulations (SCMs) versus mechanical cervical traction (MCT) for CR.

Methods

This was a randomized, open-label, controlled trial carried out at 5 hospitals in patients with CR for at least 2 weeks and neck pain. The patients received 6 treatments of SCM (n = 179) or MCT (n = 180) over 2 weeks. The primary outcome was participant-rated disability (neck disability index), measured 2 weeks after randomization. The secondary outcomes were participant-rated pain (visual analog scale) and health-related quality of life (36-Item Short Form Health Survey [SF-36]). Assessments were performed before, during, and after (2, 4, 12, and 24 weeks) intervention.

Results

After 2 weeks of treatment, the SCM group showed a greater improvement in participant-rated disability compared with the control group (P = .018). The SCM group reported less disability compared with the control group (P < .001) during the 26-week follow-up. The difference was particularly important at 6 months (mean -28.91 ± 16.43, P < .001). Significant improvements in SF-36 were noted in both groups after 2 weeks of treatment, but there were no differences between the 2 groups.

Conclusion

SCM could be a better option than MCT for the treatment of CR-related pain and disability.

SUBMITTER: Cui XJ

PROVIDER: S-EPMC5626120 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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Publications

Shi-style cervical manipulations for cervical radiculopathy: A multicenter randomized-controlled clinical trial.

Cui Xue-Jun XJ Yao Min M Ye Xiu-Lan XL Wang Ping P Zhong Wei-Hong WH Zhang Rui-Chun RC Li Hui-Ying HY Hu Zhi-Jun ZJ Tang Zhan-Ying ZY Wang Wei-Min WM Qiao Wei-Ping WP Sun Yue-Li YL Li Jun J Gao Yang Y Shi Qi Q Wang Yongjun Y

Medicine 20170801 31

<h4>Background</h4>There is a lack of high-quality evidence supporting the use of manipulation therapy for patients with cervical radiculopathy (CR). This study aimed to evaluate the effectiveness of Shi-style cervical manipulations (SCMs) versus mechanical cervical traction (MCT) for CR.<h4>Methods</h4>This was a randomized, open-label, controlled trial carried out at 5 hospitals in patients with CR for at least 2 weeks and neck pain. The patients received 6 treatments of SCM (n = 179) or MCT ( ...[more]

PMID: 28767566

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Project description:BackgroundCervical 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.Methods/designWe 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.DiscussionIf 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.Trial registrationClinical Trials.gov Identifier: NCT02705131 . Registered on 9 March 2016.

Project description:ImportanceSurgical treatment for cervical radiculopathy is increasing. Treatment with motion preserving anterior cervical disc arthroplasty was introduced to prevent symptomatic adjacent segment disease, and there is need to evaluate results of this treatment compared with standard anterior cervical discectomy and fusion.ObjectiveTo investigate clinical outcomes at 5 years for arthroplasty vs fusion in patients who underwent surgical treatment for cervical radiculopathy.Design, setting, and participantsThis multicenter, single-blinded, randomized clinical trial included patients aged 25 to 60 years with C6 or C7 radiculopathy referred to study sites' outpatient clinics from 2008 to 2013. Data were analyzed from December 2019 to December 2020.InterventionsPatients were randomly assigned to arthroplasty or fusion. Patients were blinded to which treatment they received. The surgical team was blinded until nerve root decompression was completed.Main outcomes and measuresThe primary end point was change in Neck Disability Index (NDI) score. Secondary outcomes were arm and neck pain, measured with numeric rating scales (NRS); quality of life, measured with the EuroQol-5D (EQ-5D); reoperation rates; and adjacent segment disease.ResultsAmong 147 eligible patients, 4 (2.7%) declined to participate and 7 (4.8%) were excluded. A total of 136 patients were randomized (mean [SD] age, 44.1 [7.0] years; 73 (53.7%) women), with 68 patients randomized to arthroplasty and 68 patients randomized to fusion. A total of 114 patients (83.8%) completed the 5-year follow-up. In the arthroplasty group, the mean NDI score was 45.9 (95% CI, 43.3 to 48.4) points at baseline and 22.2 (95% CI, 18.0 to 26.3) points at 5 years follow-up, and in the fusion group, mean NDI score was 51.3 (95% CI, 48.1 to 54.4) points at baseline, and 21.3 (95% CI, 17.0 to 25.6) points at 5 years follow-up. The changes in mean NDI scores between baseline and 5 years were statistically significant for arthroplasty (mean change, 24.8 [95% CI, 19.8 to 29.9] points; P < .001) and fusion (mean change, 29.9 [95% CI, 24.0 to 35.9] points; P < .001), but the change in mean NDI scores was not significantly different between groups (difference, 5.1 [95% CI, -2.6 to 12.7] points; P = .19). There were no significant differences in changes in arm pain (mean [SE] change, 3.5 [0.5] vs 3.1 [0.4]; P = .47), neck pain (mean [SE] change, 3.0 [0.5] vs 3.4 [0.5]; P = .50), EQ-5D (mean [SE] change, 0.39 [0.4] vs 0.45 [0.6]; P = .46), patients requiring reoperation (10 patients [14.7%] vs 8 patients [11.8%]; P = .61), and adjacent segment disease (0 patients vs 1 patient [1.5%]; P = .32) between the arthroplasty and fusion groups.Conclusions and relevanceIn this randomized clinical trial, patients treated with arthroplasty and fusion reported similar and substantial clinical improvement at 5 years.Trial registrationClinicalTrials.gov Identifier: NCT00735176.

Dataset Information

Shi-style cervical manipulations for cervical radiculopathy: A multicenter randomized-controlled clinical trial.

Background

Methods

Results

Conclusion

Publications

Shi-style cervical manipulations for cervical radiculopathy: A multicenter randomized-controlled clinical trial.

Similar Datasets

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