Balance Chiropractic Therapy for Cervical Spondylotic Radiculopathy

Not Applicable

• Conditions: Cervical Radiculopathy
• Interventions: Device: Balance Chiropractic Therapy; Device: Traction Therapy

• Registration Number: NCT02705131
• Lead Sponsor: Feng Yang

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 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.

Study Timeline

• Study First Submitted: 2016-02-28
• Status Verified: 2016-03
• Study First Submitted QC: 2016-03-09
• Last Update Submitted: 2016-03-09
• Study First Posted: 2016-03-10
• Last Update Posted: 2016-03-10
• Study Start: 2016-04
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Subjects who are in conformity with the diagnostic criteria of CSR;
• Aged between18 and 65 years old;
• The pain score regarding visual analog scales is more than 4 points and less than 8 points;
• sign the informed consent.

Exclusion Criteria

• Subjects will be excluded if they have disorders such as vague diagnosis of acute spinal cord injury or acute spinal cord inflammation,or cervical vertigo symptom and checking for abnormal changes on transcranial doppler(TCD).
• Subjects will also be excluded if they have combined liver, kidney, hematopoietic system, endocrine system, cardiovascular system, nervous system and other severe primary disease,or fractures,osteoarticular tuberculosis, osteomyelitis, bone tumor, severe osteoporosis,or mental disabilities,
• A weak body can not withstand the stimulation of the balance chiropractic therapy .
• Individuals who have acute infectious disease, stomach or duodenal ulcer with acute perforation,or treated areas with severe skin damage or skin diseases.
• Subjects that have received surgical treatment or neck injury, or radiofrequency of cervical intervertebral disc, or minimally invasive, or ozone, or acupuncture and moxibustion, or other manipulations or block therapy within two weeks
• Lactating or pregnant patients.
• Subjects who are participating in other clinical trials related to cervical spondylosis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Balance Chiropractic Therapy(BCT)	Balance Chiropractic Therapy	patients are in the sitting position and receive the Balance Chiropractic Therapy(BCT) .1)Balancing tendon-regulation;2) Balancing osteopathy;3) Balance collaterals-dredging.The patients will received BCT 1 time every other day, 20min each time. a total of 10 times in 20 days.
Traction Therapy(TT)	Traction Therapy	patients will receive the Traction Therapy(TT):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.

Primary Outcome Measures

Name	Time	Method
Pain Scores as measured by the Visual Analog Scale	Three months

Secondary Outcome Measures

Name	Time	Method
cervical curvature as measured by Borden method	three months
composite of functional status as measured by Neck Disability Index	three months
Health Related Quality of Life as measured by SF-36	three months