NCT02705131

Balance Chiropractic Therapy for Cervical Spondylotic Radiculopathy

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Feng Yang · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Cervical Radiculopathy

Interventions

Type	Name	Description
DEVICE	Balance Chiropractic Therapy	patients are in the sitting position and receive the following treatments.1)Balancing tendon-regulation;2) Balancing osteopathy;3) Balance collaterals-dredging.
DEVICE	Traction Therapy	patients will received the traction therapy.The patient is sitting and wearing a cloth bag occipital jaw traction comfortable,with head bending forward about 10-15 degrees in comfort.The weight for traction of cervical spondylosis is started at 3 kg, and gradually increased to the maximum weight not more than 6kg according to the standard of 0.5kg each time. The treatment is performed 30 minutes a time per day, 10 times as a course,a total of 2 courses.

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2016-03-10
• Last updated: 2016-03-10