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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 9, 2008

Last Updated Date

June 24, 2008

Start Date ^†

September 2006

Current Primary Outcome Measures ^†

Neck Disability Index [ Time Frame: 2wk, 4wk, 3mo, 6mo ] [ Designated as safety issue: No ]
Patient Specific Functional Scale [ Time Frame: 2wk, 4wk, 3mo, 6mo ] [ Designated as safety issue: No ]
Numeric Pain Rating Scale [ Time Frame: 2wk, 4wk, 3mo, 6mo ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00695006 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Global Rating Of Change [ Time Frame: 2wk, 4wk, 3mo, 6mo ] [ Designated as safety issue: No ]
Body Diagram [ Time Frame: 2wk, 4wk, 3mo, 6mo ] [ Designated as safety issue: No ]
Fear Avoidance Belief Questionnaire [ Time Frame: 2wk, 4wk, 3mo, 6mo ] [ Designated as safety issue: No ]
Satisfaction [ Time Frame: 2wk, 4wk, 3mo, 6mo ] [ Designated as safety issue: No ]
Grip Strength [ Time Frame: 2wk, 4wk ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

GROC [ Time Frame: 2wk, 4wk, 3mo, 6mo ] [ Designated as safety issue: No ]
Body Diagram [ Time Frame: 2wk, 4wk, 3mo, 6mo ] [ Designated as safety issue: No ]
FABQ [ Time Frame: 2wk, 4wk, 3mo, 6mo ] [ Designated as safety issue: No ]
Satisfaction [ Time Frame: 2wk, 4wk, 3mo, 6mo ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

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.

Detailed Description

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^†

Cervical Radiculopathy

Intervention ^†

Other: Sham Traction
Other: Traction

Study Arms / Comparison Groups

Sham Comparator: Sham Traction
Active Comparator: Traction

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Estimated Completion Date

July 2008

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00695006

Responsible Party

Ian Young, Advance Rehab

Secondary IDs ^††

Study Sponsor ^†

Rocky Mountain University of Health Professions

Collaborators ^††

Investigators ^†

Principal Investigator:

Ian A Young, PT

Advance Rehab at Fredericksburg Orthopaedics

Information Provided By

Rocky Mountain University of Health Professions

Verification Date

June 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.