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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00695006
Recruitment Status : Unknown
Verified June 2008 by Rocky Mountain University of Health Professions.
Recruitment status was:  Active, not recruiting
First Posted : June 11, 2008
Last Update Posted : June 25, 2008
Sponsor:
Information provided by:

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
Cervical Radiculopathy Other: Sham Traction Other: Traction

Study Design

Study Type : Interventional  (Clinical Trial)
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 : September 2006
Primary Completion Date : December 2007
Estimated Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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


Outcome Measures

Primary Outcome Measures :
  1. Neck Disability Index [ Time Frame: 2wk, 4wk, 3mo, 6mo ]
  2. Patient Specific Functional Scale [ Time Frame: 2wk, 4wk, 3mo, 6mo ]
  3. Numeric Pain Rating Scale [ Time Frame: 2wk, 4wk, 3mo, 6mo ]

Secondary Outcome Measures :
  1. Global Rating Of Change [ Time Frame: 2wk, 4wk, 3mo, 6mo ]
  2. Body Diagram [ Time Frame: 2wk, 4wk, 3mo, 6mo ]
  3. Fear Avoidance Belief Questionnaire [ Time Frame: 2wk, 4wk, 3mo, 6mo ]
  4. Satisfaction [ Time Frame: 2wk, 4wk, 3mo, 6mo ]
  5. Grip Strength [ Time Frame: 2wk, 4wk ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ian Young, Advance Rehab
ClinicalTrials.gov Identifier: NCT00695006     History of Changes
Other Study ID Numbers: 5388642
First Posted: June 11, 2008    Key Record Dates
Last Update Posted: June 25, 2008
Last Verified: June 2008

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