- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01500967
Shi-style Cervical Manipulations for Cervical Radiculopathy
Shi-style Cervical Manipulations for Cervical Radiculopathy-A Randomized Single Blinded Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Radiculopathy generally presents with pain, numbness, or weakness in a dermatomal distribution. Causative factors include an acute nucleus pulposus herniation, spondylitic changes around the foramen causing nerve compression, or a combination of these.
Cervical radiculopathy results from impingement on a nerve root by either spondylotic narrowing of the neural foramen or a lateral intervertebral disc herniation. Frequent complaints include painful neck movements, radicular pain, paraspinal muscle spasm, muscle weakness, and diminished deep tendon reflexes (Radhakrishnan K, 1994). Radiculopathy tends to produce substantial limitation of movement of the head and neck.
The goals of any treatment plan should be well defined. Specifically, it should be the goal of the treating physician to relieve pain, improve function, and prevent recurrence. Although some symptomatic patients meet surgical criteria, most patients are clearly candidates for nonoperative treatment. Treatment modalities for radiculopathy include rest, medications, physical therapy, manipulation, injections, and patient education.
Various studies have shown that nonoperative management of cervical radiculopathy leaves a substantial minority of patients with persistently troublesome symptoms (Lees F, 1963,41, 42). Lees and Turner found that in two thirds of patients, symptoms tend to persist in the absence of surgical treatment (Lees F, 1963). DePalma and Subin found that of 255 patients treated nonoperatively, only 29% experienced complete symptom relief (Radhakrishnan K, 1994,41). Better outcomes with nonoperative management, however, have been observed in studies that were based in physiotherapy centers than those from surgical series (Radhakrishnan K, 1994).
Spinal balance is the way Professor Shi Qi " Arthralgia theory" and " The theory of muscle imbalance " theory under the guidance of mix martial arts, Wang Shi expertise and Traumatology, combined with clinical experience and experimental research. Rub, take, roll, put, loose, pull, friction, shaking, pinching, so called "nine manipulations." It can adjust qi and blood, phlegm stasis, Dredge meridians, spasm pain, support organs, alleviate, correct cervical dynamic and static imbalance. Three steps and nine manipulations is the common method of treatment of Professor Shi Qi for cervical disease .
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200032
- Recruiting
- Longhua Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Informed consent and signed an informed consent;
- aged 18 to 65 year-old male or female ;
- appear cervical nerve root symptoms typical of 3 months to 5 years;
- VAS pain greater than 30 mm.
- positive for one of the following :Brachial plexus traction test, Foraminal compression test, Neck rotation test is less than 60 degrees, Foraminal separation test, Decreased muscle strength.
Exclusion Criteria:
- nerve root in the past received surgical treatment of cervical or neck trauma;
- with obvious symptoms of vertigo, TCD examination there was abnormal;
- signs and symptoms of spinal cord compression, MRI found that spinal cord oppressors[e];
- pregnant women, lactating women;
- can not attend follow-up (such as six months or less distance of immigrant relocation plan, no mobile phones and other communication tools, etc.), and no ability to participate in six months follow-up of patients;
- currently participating in cervical spondylosis associated with other clinical trials;
- hepatic, renal, hematopoietic system, endocrine system, cardiovascular, nervous system, primary and other serious diseases, tuberculosis, vertebral deformities, cancer and mental illness;
- There are opioid analgesics, sedative hypnotics and alcohol abuse history;
- those who can not read and write Chinese.
- the past two weeks received RF, minimally invasive , ozone , a small knife , or other manual therapy and Closed injection treatment.
- vertebral displacement, forward, backward or lateral horizontal displacement > 3 mm, the angulation between adjacent intervertebral > 11 °.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Traction
6kg to 10kg, 3 times a week, once the other day(except the weekends),20 minutes, 2 weeks.
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6kg to 10kg, 3 times a week, once the other day(except the weekends),20 minutes, 2 weeks.
Other Names:
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EXPERIMENTAL: Manipulations
Shi-style manipulations is a cervical manipulation for cervical radiculopathy.This manipulation is a kind of traditional Chinese massage and it can dredge the meridians.
Patients are treated every day for 30 minutes.
Seven times as one course and totally there are two courses.
3 times a week, once the other day(except the weekends),30 minutes, 2 weeks.
|
Shi-style cervical manipulation is a spinal manipulation for cervical radiculopathy.It is a kind of traditional chinese massage and can dredge the meridian.Patients are treated every day for 30 minutes.Seven times at one course and totally there are two courses.3
times a week, once the other day(except the weekends),30 minutes, 2 weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Neck Disability Index
Time Frame: changes from baseline at 2 weeks
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changes from baseline at 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
SF 36
Time Frame: changes from baseline at 2 weeks
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changes from baseline at 2 weeks
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Visual Analogue Scale
Time Frame: changes from baseline at 2 weeks
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changes from baseline at 2 weeks
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Neck Disability Index
Time Frame: changes from baseline at 4 weeks
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changes from baseline at 4 weeks
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SF 36
Time Frame: 4 weeks
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4 weeks
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Visual Analogue Scale
Time Frame: 4 weeks
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4 weeks
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Neck Disability Index
Time Frame: changes from baseline at 3 months
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changes from baseline at 3 months
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SF 36
Time Frame: changes from baseline at 3 months
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changes from baseline at 3 months
|
Visual Analogue Scale
Time Frame: changes from baseline at 3 months
|
changes from baseline at 3 months
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Neck Disability Index
Time Frame: changes from baseline at 6 months
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changes from baseline at 6 months
|
SF 36
Time Frame: changes from baseline at 6 months
|
changes from baseline at 6 months
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Visual Analogue Scale
Time Frame: changes from baseline at 6 months
|
changes from baseline at 6 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yongjun Wang, MD, Shanghai University of Traditional Chinese Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Manual Therapy for Cervicalgia
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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