Shi-style Cervical Manipulations for Cervical Radiculopathy

NCT01500967 | Unknown DMC

• 1 other identifier: Manual Therapy for Cervicalgia
• Study Type: interventional
• Target: 648
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Radiculopathy

Outcome Measures

Primary Outcomes (1)

• Neck Disability Index

  changes from baseline at 2 weeks

Secondary Outcomes (11)

• SF 36

  changes from baseline at 2 weeks

• Visual Analogue Scale

  changes from baseline at 2 weeks

• Neck Disability Index

  changes from baseline at 4 weeks

• SF 36

  4 weeks

• Visual Analogue Scale

  4 weeks

Study Arms (2)

Traction

ACTIVE COMPARATOR

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

Other: Cervical Traction control

Manipulations

EXPERIMENTAL

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.

Other: Shi-style cervical manipulations

Interventions

Shi-style cervical manipulations OTHER

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.

Also known as: manipulations for cervical radiculopathy

Manipulations

Cervical Traction control OTHER

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

Also known as: Cervical traction

Traction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 °.

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead
• Tianjin University of Traditional Chinese Medicine: collaborator

Study Sites (1)

Longhua Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Yongjun Wang, MD

  Shanghai University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuejun Cui, Dr

CONTACT

13917715524@139.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Longhua Hospital

Study Record Dates

• First Submitted: August 30, 2011
• First Posted: December 29, 2011
• Study Start: December 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2014
• Last Updated: January 25, 2012

Record last verified: 2012-01

Locations

CN (1)