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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Rocky Mountain University of Health Professions.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Rocky Mountain University of Health Professions
ClinicalTrials.gov Identifier:
NCT00695006
First received: June 9, 2008
Last updated: June 24, 2008
Last verified: June 2008
  Purpose

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 Intervention
Cervical Radiculopathy
Other: Sham Traction
Other: Traction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Manual Therapy, Exercise and Traction for Patients With Cervical Radiculopathy: A RCT

Resource links provided by NLM:


Further study details as provided by Rocky Mountain University of Health Professions:

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 ]

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 ]

Enrollment: 81
Study Start Date: September 2006
Estimated Study Completion Date: July 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: II
Sham Traction
Other: Sham Traction
Traction <5lbs
Active Comparator: I
Traction
Other: Traction
Standard supine intermittent traction

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00695006

Locations
United States, Virginia
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
  More Information

No publications provided

Responsible Party: Ian Young, Advance Rehab
ClinicalTrials.gov Identifier: NCT00695006     History of Changes
Other Study ID Numbers: 5388642
Study First Received: June 9, 2008
Last Updated: June 24, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Rocky Mountain University of Health Professions:
manual therapy, cervical traction, cervical radiculopathy

Additional relevant MeSH terms:
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014