Manual Therapy, Exercise and Traction for Patients With Cervical Radiculopathy: A RCT

Sponsor

Rocky Mountain University of Health Professions (Other)

Overall Status

Unknown status

CT.gov ID

NCT00695006

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To date, optimal strategies for the management of patients with Cervical Radiculopathy (CR) remain elusive. The purpose of this study was to compare the effects of manual therapy, exercise, and cervical traction to manual therapy, exercise, and sham traction on pain, function and disability in patients with CR.

Condition or Disease	Intervention/Treatment	Phase
Cervical Radiculopathy	Other: Sham Traction Other: Traction	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

81 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Manual Therapy, Exercise and Traction for Patients With Cervical Radiculopathy: A RCT

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Dec 1, 2007

Anticipated Study Completion Date :

Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: II Sham Traction	Other: Sham Traction Traction <5lbs
Active Comparator: I Traction	Other: Traction Standard supine intermittent traction

Arm

Intervention/Treatment

Sham Comparator: II

Sham Traction

Other: Sham Traction

Traction <5lbs

Active Comparator: I

Traction

Other: Traction

Standard supine intermittent traction

Outcome Measures

Primary Outcome Measures

Neck Disability Index [2wk, 4wk, 3mo, 6mo]
Patient Specific Functional Scale [2wk, 4wk, 3mo, 6mo]
Numeric Pain Rating Scale [2wk, 4wk, 3mo, 6mo]

Secondary Outcome Measures

Global Rating Of Change [2wk, 4wk, 3mo, 6mo]
Body Diagram [2wk, 4wk, 3mo, 6mo]
Fear Avoidance Belief Questionnaire [2wk, 4wk, 3mo, 6mo]
Satisfaction [2wk, 4wk, 3mo, 6mo]
Grip Strength [2wk, 4wk]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

3 of 4 positive on CPR, 18-70yrs

Exclusion Criteria:

history of previous cervical or thoracic spine surgery
bilateral upper extremity symptoms
signs or symptoms of UMN disease
medical "red flags"(tumor, fracture, rheumatoid arthritis, osteoporosis, prolonged steroid use)
cervical spine injections (steroidal) in the past two weeks
current use of steroidal medication prescribed for their radiculopathy symptoms

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Advance Rehab at Fredericksburg Orthopaedics	Fredericksburg	Virginia	United States	22401

Sponsors and Collaborators

Rocky Mountain University of Health Professions

Investigators

Principal Investigator: Ian A Young, PT, Advance Rehab at Fredericksburg Orthopaedics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00695006

Other Study ID Numbers:

5388642

First Posted:

Jun 11, 2008

Last Update Posted:

Jun 25, 2008

Last Verified:

Jun 1, 2008

Keywords provided by , ,

manual therapy, cervical traction, cervical radiculopathy

Additional relevant MeSH terms:

Radiculopathy

Study Results

No Results Posted as of Jun 25, 2008