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

Primary Purpose

Cervical Radiculopathy

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sham Traction
Traction
Sponsored by
Rocky Mountain University of Health Professions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Radiculopathy focused on measuring manual therapy, cervical traction, cervical radiculopathy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Advance Rehab at Fredericksburg Orthopaedics

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

II

I

Arm Description

Sham Traction

Traction

Outcomes

Primary Outcome Measures

Neck Disability Index
Patient Specific Functional Scale
Numeric Pain Rating Scale

Secondary Outcome Measures

Global Rating Of Change
Body Diagram
Fear Avoidance Belief Questionnaire
Satisfaction
Grip Strength

Full Information

First Posted
June 9, 2008
Last Updated
June 24, 2008
Sponsor
Rocky Mountain University of Health Professions
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1. Study Identification

Unique Protocol Identification Number
NCT00695006
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
July 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Rocky Mountain University of Health Professions

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radiculopathy
Keywords
manual therapy, cervical traction, cervical radiculopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
II
Arm Type
Sham Comparator
Arm Description
Sham Traction
Arm Title
I
Arm Type
Active Comparator
Arm Description
Traction
Intervention Type
Other
Intervention Name(s)
Sham Traction
Intervention Description
Traction <5lbs
Intervention Type
Other
Intervention Name(s)
Traction
Intervention Description
Standard supine intermittent traction
Primary Outcome Measure Information:
Title
Neck Disability Index
Time Frame
2wk, 4wk, 3mo, 6mo
Title
Patient Specific Functional Scale
Time Frame
2wk, 4wk, 3mo, 6mo
Title
Numeric Pain Rating Scale
Time Frame
2wk, 4wk, 3mo, 6mo
Secondary Outcome Measure Information:
Title
Global Rating Of Change
Time Frame
2wk, 4wk, 3mo, 6mo
Title
Body Diagram
Time Frame
2wk, 4wk, 3mo, 6mo
Title
Fear Avoidance Belief Questionnaire
Time Frame
2wk, 4wk, 3mo, 6mo
Title
Satisfaction
Time Frame
2wk, 4wk, 3mo, 6mo
Title
Grip Strength
Time Frame
2wk, 4wk

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian A Young, PT
Organizational Affiliation
Advance Rehab at Fredericksburg Orthopaedics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advance Rehab at Fredericksburg Orthopaedics
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22401
Country
United States

12. IPD Sharing Statement

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

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