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Shi-style Cervical Manipulations for Cervical Radiculopathy

Primary Purpose

Cervical Radiculopathy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Shi-style cervical manipulations
Cervical Traction control
Sponsored by
Shanghai University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Radiculopathy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 °.

Sites / Locations

  • Longhua HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traction

Manipulations

Arm Description

6kg to 10kg, 3 times a week, once the other day(except the weekends),20 minutes, 2 weeks.

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.

Outcomes

Primary Outcome Measures

Neck Disability Index

Secondary Outcome Measures

SF 36
Visual Analogue Scale
Neck Disability Index
SF 36
Visual Analogue Scale
Neck Disability Index
SF 36
Visual Analogue Scale
Neck Disability Index
SF 36
Visual Analogue Scale

Full Information

First Posted
August 30, 2011
Last Updated
January 24, 2012
Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Tianjin University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01500967
Brief Title
Shi-style Cervical Manipulations for Cervical Radiculopathy
Official Title
Shi-style Cervical Manipulations for Cervical Radiculopathy-A Randomized Single Blinded Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Tianjin University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Neck pain and related problems occur frequently in modern societies and have a considerable impact on individuals and the society. Cervical radiculopathy (CR) generally presents with pain, numbness, or weakness in a dermatomal distribution. CR results from impingement on a nerve root by either spondylotic narrowing of the neural foramen or a lateral intervertebral disc herniation. Various studies have shown that nonoperative management for CR is effective, such as medications, physical therapy, Spinal manipulation, traction, acupuncture, collar immobilization and epidural steroid injections. Spinal manipulation is one of the manual techniques for treating mechanical neck pain. No high-quality evidence has proved the effectiveness of manipulative therapy in the treatment of cervical radiculopathy. However, limited evidence suggests that manipulation may provide short-term benefit in the treatment of neck pain, cervicogenic headaches and radicular symptoms. Few complications, such as worsening radiculopathy, myelopathy, and spinal cord injury, may occur. Spinal massage manipulation is used for centuries in China. Many patients with cervical disc disease are increasingly turning to manipulations to alleviate their symptoms and reduce the side effects of medications. The goal of this study is to determine the efficacy of a spinal manipulation, three steps and nine manipulations, on treating with the cervical radiculopathy.
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radiculopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
648 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traction
Arm Type
Active Comparator
Arm Description
6kg to 10kg, 3 times a week, once the other day(except the weekends),20 minutes, 2 weeks.
Arm Title
Manipulations
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Shi-style cervical manipulations
Other Intervention Name(s)
manipulations for cervical radiculopathy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cervical Traction control
Other Intervention Name(s)
Cervical traction
Intervention Description
6kg to 10kg, 3 times a week, once the other day(except the weekends),20 minutes, 2 weeks.
Primary Outcome Measure Information:
Title
Neck Disability Index
Time Frame
changes from baseline at 2 weeks
Secondary Outcome Measure Information:
Title
SF 36
Time Frame
changes from baseline at 2 weeks
Title
Visual Analogue Scale
Time Frame
changes from baseline at 2 weeks
Title
Neck Disability Index
Time Frame
changes from baseline at 4 weeks
Title
SF 36
Time Frame
4 weeks
Title
Visual Analogue Scale
Time Frame
4 weeks
Title
Neck Disability Index
Time Frame
changes from baseline at 3 months
Title
SF 36
Time Frame
changes from baseline at 3 months
Title
Visual Analogue Scale
Time Frame
changes from baseline at 3 months
Title
Neck Disability Index
Time Frame
changes from baseline at 6 months
Title
SF 36
Time Frame
changes from baseline at 6 months
Title
Visual Analogue Scale
Time Frame
changes from baseline at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 °.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuejun Cui, Dr
Email
13917715524@139.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongjun Wang, MD
Organizational Affiliation
Shanghai University of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Longhua Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuejun cui, Dr
Email
13917715524@139.com

12. IPD Sharing Statement

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Shi-style Cervical Manipulations for Cervical Radiculopathy

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