Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

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

Authors: Feng Yang, Wen-xiong Li, Zhu Liu, Li Liu

Published in: Trials | Issue 1/2016

Login to get access

Abstract

Background

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.

Methods/design

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.

Discussion

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.

Trial registration

Clinical Trials.gov Identifier: NCT02705131. Registered on 9 March 2016.
Literature
1.
Zhu L-g, Yu J. Research progress of non-operative treatment for cervical spondylotic radiculopathy. Chin J Trad Med Traum Orthop. 2011;19(4):66–9.
2.
Tanaka Y, Kokubun S, Sato T, et al. Cervical roots as origin of pain in the neck or scapular regions. Spine. 2006;31(17):568–73.CrossRef
3.
Wang Y-g, Guo X-q, Zhang Q, et al. A systematic review on the treatment of nerve root cervical disease by manipulation. Chin J Trad Chin Med Phar. 2013;28(2):499–503.
4.
Yan H-x, Su Y, Zhou G-h, et al. Research progress of non-operative treatment for cervical spondylosis of nerve root type. Chin Community Doct. 2015;31(36):5–6.
5.
Zhao C, Bai Y. Clinical observation on the treatment of cervical spondylotic radiculopathy with optimized scheme of comprehensive non-operative therapy. Rheum Arthritis. 2014;3(11):27–9. 44.
6.
J-w Z, Z-y J, R-b Y, et al. Controlled study on treatment of cervical spondylopathy of the nerve root type with acupuncture, moxibustion and massage as main. Chin Acupunct Moxibustion. 2006;26(8):537–43.
7.
Y-c W, Dong T, Wu X-m, et al. The review of massage treatment of cervical spondylosis of nerve root type. J Trad Chin Orthop Trauma. 2015;27(10):65–7.
8.
Wang Z-q, J-m D. Advances in massage therapy for nerve root cervical spondylopathy. Acad J Chin PLA Med Sch. 2014;35(8):873–5.
9.
J-p L, Y-k L, Wang Z-h. The study on reliability of four methods of measurement for cervical lordosis. J Cervicodvnia Lumbodvnia. 2002;23(4):278–80.
10.
Wan C, Shen H, Liu Z. Uniformity of the Borden’ s and Harrison’ s methods for measuring cervical spine alignment. Chinese. J Spine Spinal Cord. 2012;22(1):34–6.
11.
Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991;14(7):409–15.PubMed
12.
Campa-Moran I, Rey-Gudin E, Fernandez-Carnero J, et al. Comparison of dry needling versus orthopedic manual therapy in patients with myofascial chronic neck pain: a single-blind, randomized pilot study. Pain Res Treat. 2015;(534):1–15.
13.
MacDermid JC, Walton DM, Avery S, et al. Measurement properties of the Neck Disability Index: a systematic review. J Orthop Sports Phys Ther. 2009;39(5):400–17.CrossRefPubMed
14.
Busija L, Pausenberger E, Haines TP, et al. Adult measures of general health and health-related quality of life. Defining general health measures and HRQOL. 2011;63(S11):S383–412.
15.
Carlin JB, Doyle LW. Statistics for clinicians.7: sample size. J Paediatr Child Health. 2002;38:300–4.CrossRefPubMed
16.
Zhu L-g. Clinical research of rotational technique for the pain VAS scores of cervical spondylosis radiculopathy. Beijing Chin Med. 2005;24(5):297–8.
17.
18.
Anderson JS, Hsu AW, Vasavada N. Morphology, architecture, and biomechanics of human cervical multifidus. Spine (Phila Pa 1976). 2005;30(4):E86–91.CrossRef
19.
Ohnhaus EE, Adler R. Methodological problems in the measurement of pain: a comparison between the verbal rating scale and the visual analogue scale. Pain. 1975;1(4):379–84.CrossRefPubMed
20.
Jie WJ, Li J. Exploration of the effect of tuina techniques for lumbar intervertebral disc herniation. Gansu Zhongyi. 2008;21(2):41–2.
21.
Lu JZ, Li YP. Clinical observation on electroacupuncture plus sitting-position pulling and stretching reduction manipulation for the treatment of cervical vertigo. Shanghai Zhenjiu Zazhi. 2013;32(6):495–6.
22.
Hua Y. Clinical observation on treatment of cervical spondylotic radiculopathy with combined electro-acupuncture tuina and traction. J Acupunct Tuina Sci. 2009;7(3):156–8.CrossRef
23.
Wang S-n, Sheng F, Pan Y-h, et al. Clinical study on Tuina combined with auricular point sticking for cervical radiculopathy. J Acupunct Tuina Sci. 2014;12(4):230–5.CrossRef
24.
Guan Z-x. Chinese earpins school. Shanghai: Shanghai Science and Technology Publishing House; 1994. p. 440–3.
Metadata
Title
Balance chiropractic therapy for cervical spondylotic radiculopathy: study protocol for a randomized controlled trial
Authors
Feng Yang
Wen-xiong Li
Zhu Liu
Li Liu
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1644-2

Other articles of this Issue 1/2016

Trials 1/2016 Go to the issue

Study protocol

The importance of albumin infusion rate for plasma volume expansion following major abdominal surgery – AIR: study protocol for a randomised controlled trial

Study protocol

Metamizole versus ibuprofen at home after day surgery: study protocol for a randomised controlled trial

Study protocol

Translating knowledge for action against stroke – using 5-minute videos for stroke survivors and caregivers to improve post-stroke outcomes: study protocol for a randomized controlled trial (Movies4Stroke)

Study protocol

Reduction of self-perceived discomforts in critically ill patients in French intensive care units: study protocol for a cluster-randomized controlled trial

Study protocol

START NOW - a comprehensive skills training programme for female adolescents with oppositional defiant and conduct disorders: study protocol for a cluster-randomised controlled trial

Study protocol

Evaluating optimal patient-turning procedures for reducing hospital-acquired pressure ulcers (LS-HAPU): study protocol for a randomized controlled trial