Balance Chiropractic Therapy for Cervical Spondylotic Radiculopathy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Radiculopathy

Intervention / Treatment
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* Device: Balance Chiropractic Therapy
* Device: Traction Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Balance Chiropractic Therapy(BCT)<br>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. | Device: Balance Chiropractic Therapy<br>* patients are in the sitting position and receive the following treatments.1)Balancing tendon-regulation;2) Balancing osteopathy;3) Balance collaterals-dredging.<br>|
| Active Comparator: Traction Therapy(TT)<br>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. | Device: Traction Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores as measured by the Visual Analog Scale |  | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical radiculopathy, Balance chiropractic therapy