Clinical Trial: Balance Chiropractic Therapy for Cervical Spondylotic Radiculopathy

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Balance Chiropractic Therapy for Cervical Spondylotic Radiculopathy: a Randomized Parallel-controlled Trial

Brief Summary: The purpose of this study is to evaluate the therapeutic effect and safety of the Balance Chiropractic Therapy(BCT) on Cervical Spondylotic Radiculopathy and to investigate the mechanism of which this efficacy is achieved.

Detailed Summary: The investigators propose a multi center randomized, parallel-controlled trial to evaluate the efficacy and safety of the balance chiropractic therapy for CSR. Participants aged 18 to 65, who are in conformity with the diagnostic criteria of CSR and the pain score regarding visual analog scales is more than 4 points and less than 8 points, will be included and randomly allocated into two groups: test group and control group. Participants in the test group will be treated with the balance chiropractic therapy, while the control group will receive the traction therapy. The primary outcome is pain severity (measured with a visual analogue scale (VAS)). Secondary outcomes will include cervical curvature (measured by Borden index), a composite of functional status(measured by Neck Disability Index ,NDI), individual patients health status(evaluated by SF-36 health survey ), and adverse events as reported in the trial.
Sponsor: Feng Yang

Current Primary Outcome: Pain Scores as measured by the Visual Analog Scale [ Time Frame: Three months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • cervical curvature as measured by Borden method [ Time Frame: three months ]
  • composite of functional status as measured by Neck Disability Index [ Time Frame: three months ]
  • Health Related Quality of Life as measured by SF-36 [ Time Frame: three months ]


Original Secondary Outcome: Same as current

Information By: Shaanxi University of Chinese Medicine

Dates:
Date Received: February 28, 2016
Date Started: April 2016
Date Completion: July 2017
Last Updated: March 9, 2016
Last Verified: March 2016