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

June 24, 2008 updated by: Rocky Mountain University of Health Professions
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Fredericksburg, Virginia, United States, 22401
        • Advance Rehab at Fredericksburg Orthopaedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neck Disability Index
Time Frame: 2wk, 4wk, 3mo, 6mo
2wk, 4wk, 3mo, 6mo
Patient Specific Functional Scale
Time Frame: 2wk, 4wk, 3mo, 6mo
2wk, 4wk, 3mo, 6mo
Numeric Pain Rating Scale
Time Frame: 2wk, 4wk, 3mo, 6mo
2wk, 4wk, 3mo, 6mo

Secondary Outcome Measures

Outcome Measure
Time Frame
Global Rating Of Change
Time Frame: 2wk, 4wk, 3mo, 6mo
2wk, 4wk, 3mo, 6mo
Body Diagram
Time Frame: 2wk, 4wk, 3mo, 6mo
2wk, 4wk, 3mo, 6mo
Fear Avoidance Belief Questionnaire
Time Frame: 2wk, 4wk, 3mo, 6mo
2wk, 4wk, 3mo, 6mo
Satisfaction
Time Frame: 2wk, 4wk, 3mo, 6mo
2wk, 4wk, 3mo, 6mo
Grip Strength
Time Frame: 2wk, 4wk
2wk, 4wk

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rocky Mountain University of Health Professions

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Anticipated)

July 1, 2008

Study Registration Dates

First Submitted

June 9, 2008

First Submitted That Met QC Criteria

June 10, 2008

First Posted (Estimate)

June 11, 2008

Study Record Updates

Last Update Posted (Estimate)

June 25, 2008

Last Update Submitted That Met QC Criteria

June 24, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5388642

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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