PMID- 27770801
OWN - NLM
STAT- MEDLINE
DCOM- 20180126
LR  - 20181113
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 17
IP  - 1
DP  - 2016 Oct 22
TI  - Balance chiropractic therapy for cervical spondylotic radiculopathy: study 
      protocol for a randomized controlled trial.
PG  - 513
LID - 513
AB  - 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.
FAU - Yang, Feng
AU  - Yang F
AD  - Shaanxi University of Chinese Medicine, Xi'an, 712000, China. 
      yangfengdudu@163.com.
AD  - Affiliated Hospital of Shaanxi University of Chinese Medicine, Xi'an, 712083, 
      China. yangfengdudu@163.com.
FAU - Li, Wen-Xiong
AU  - Li WX
AD  - Shaanxi University of Chinese Medicine, Xi'an, 712000, China.
AD  - Affiliated Hospital of Shaanxi University of Chinese Medicine, Xi'an, 712083, 
      China.
FAU - Liu, Zhu
AU  - Liu Z
AD  - Shaanxi University of Chinese Medicine, Xi'an, 712000, China.
AD  - Affiliated Hospital of Shaanxi University of Chinese Medicine, Xi'an, 712083, 
      China.
FAU - Liu, Li
AU  - Liu L
AD  - Shaanxi University of Chinese Medicine, Xi'an, 712000, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT02705131
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20161022
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
SB  - IM
MH  - Cervical Vertebrae
MH  - *Clinical Protocols
MH  - Humans
MH  - Manipulation, Chiropractic/*methods
MH  - Radiculopathy/*therapy
MH  - Sample Size
MH  - Spondylosis/*therapy
PMC - PMC5075147
OTO - NOTNLM
OT  - Balance chiropractic therapy
OT  - Cervical spondylotic radiculopathy
OT  - Efficacy
OT  - Safety
EDAT- 2016/10/25 06:00
MHDA- 2018/01/27 06:00
PMCR- 2016/10/22
CRDT- 2016/10/25 06:00
PHST- 2016/03/24 00:00 [received]
PHST- 2016/09/25 00:00 [accepted]
PHST- 2016/10/25 06:00 [pubmed]
PHST- 2018/01/27 06:00 [medline]
PHST- 2016/10/25 06:00 [entrez]
PHST- 2016/10/22 00:00 [pmc-release]
AID - 10.1186/s13063-016-1644-2 [pii]
AID - 1644 [pii]
AID - 10.1186/s13063-016-1644-2 [doi]
PST - epublish
SO  - Trials. 2016 Oct 22;17(1):513. doi: 10.1186/s13063-016-1644-2.