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The Value of Traction in the Treatment of Cervical Radiculopathy

Primary Purpose

Radiculopathy, Neck Pain, Spinal Diseases

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Physical therapy rehabilitation
Physical therapy rehabilitation
Physical therapy rehabilitation
Sponsored by
Intermountain Health Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiculopathy focused on measuring Radiculopathy, Neck pain, Physical therapy modalities, Rehabilitation

Eligibility Criteria

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

Inclusion Criteria:

  1. Primary complaint of neck pain with symptoms (pain and/or numbness) extending distal to the acromioclavicular joint or caudal to the superior border of the scapula (may be unilateral or bilateral).
  2. Age between 18-70 years old
  3. Neck Disability Score score >10 points

Exclusion Criteria:

  1. Red flags indicative of a serious or non-musculoskeletal condition (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
  2. Diagnosis of cervical spinal stenosis based on CT or MRI imaging
  3. Evidence of cervical myelopathy or central nervous system involvement, (e.g., hyperreflexia, intrinsic muscle wasting of the hands, unsteadiness during gait, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, presence of pathologic reflexes (i.e. positive Hoffman's or Babinski reflex).
  4. Prior surgery to the neck or thoracic spine
  5. Inability to comply with treatment and follow-up schedule

Sites / Locations

  • Wilford Hall Medical Center
  • Intermountain Healthcare, Rehab Agency

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Standard exercise

Over-door traction and exercise.

Mechanical traction and exercise

Arm Description

Subjects will be instructed in neck and postural exercises.

Subjects will receive traction utilizing an over-the-door traction unit in addition to neck and postural exercises.

Mechanical cervical traction will be utilized in addition to neck and postural exercises.

Outcomes

Primary Outcome Measures

Neck Disability Questionnaire

Secondary Outcome Measures

Global Rating of Change

Full Information

First Posted
September 16, 2009
Last Updated
November 14, 2014
Sponsor
Intermountain Health Care, Inc.
Collaborators
University of Utah, 59th Medical Wing, Empi, A DJO Company
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1. Study Identification

Unique Protocol Identification Number
NCT00979108
Brief Title
The Value of Traction in the Treatment of Cervical Radiculopathy
Official Title
The Value of Mechanical Traction in the Treatment of Cervical Radiculopathy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Intermountain Health Care, Inc.
Collaborators
University of Utah, 59th Medical Wing, Empi, A DJO Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the effectiveness of adding mechanical traction to standard physical therapy treatments for patients with neck and arm pain.
Detailed Description
Cervical traction is an intervention frequently recommended for the treatment of patients with neck pain. Systematic reviews have not endorsed the use of mechanical traction for patients with neck pain, however these reviews note the poor methodological quality of available research. Trials that have been performed have examined heterogeneous samples of patients with neck pain. It may be that cervical traction has not shown to be effective because only a specific subgroup may benefit from it. Most experts believe that traction is most beneficial for individuals with neck pain extending into the upper extremity who have signs of nerve root compression. Randomized clinical trials examining the effectiveness of traction for patients with these specific characteristics have not been performed. Preliminary studies support the hypothesis that there exists a specific subgroup of patients with neck pain likely to benefit from traction The current study will address 3 important questions: Will the existence of a more specific subgroup of patients who benefit from traction along with a standard exercise program be validated in a second sample of patients? Is cervical traction a critical component of the treatment necessary to maximize outcomes for patients in this subgroup? Do two commonly used traction protocols differ in their effectiveness for patients in this subgroup? (Specifically, we study will compare supine mechanical traction to over-the-door traction.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiculopathy, Neck Pain, Spinal Diseases, Musculoskeletal Diseases, Neuromuscular Diseases, Intervertebral Disk Displacement
Keywords
Radiculopathy, Neck pain, Physical therapy modalities, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard exercise
Arm Type
Active Comparator
Arm Description
Subjects will be instructed in neck and postural exercises.
Arm Title
Over-door traction and exercise.
Arm Type
Experimental
Arm Description
Subjects will receive traction utilizing an over-the-door traction unit in addition to neck and postural exercises.
Arm Title
Mechanical traction and exercise
Arm Type
Experimental
Arm Description
Mechanical cervical traction will be utilized in addition to neck and postural exercises.
Intervention Type
Other
Intervention Name(s)
Physical therapy rehabilitation
Other Intervention Name(s)
Saunders 3D Active Trac
Intervention Description
Mechanical cervical traction will be applied at a moderate force and adjusted based on symptom relief. In addition, subjects will be trained in cervical and postural exercises.
Intervention Type
Other
Intervention Name(s)
Physical therapy rehabilitation
Intervention Description
Subjects will be instructed in use of an over-the-door traction unit utilizing weights up to 20 pounds in sitting. In addition, subjects will be trained in neck and postural exercises.
Intervention Type
Other
Intervention Name(s)
Physical therapy rehabilitation
Intervention Description
Subjects will be instructed in neck and postural exercises.
Primary Outcome Measure Information:
Title
Neck Disability Questionnaire
Time Frame
Baseline, 4 weeks, 6 months, 1year
Secondary Outcome Measure Information:
Title
Global Rating of Change
Time Frame
Baseline, 4 weeks, 6 months, 1 year

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: Primary complaint of neck pain with symptoms (pain and/or numbness) extending distal to the acromioclavicular joint or caudal to the superior border of the scapula (may be unilateral or bilateral). Age between 18-70 years old Neck Disability Score score >10 points Exclusion Criteria: Red flags indicative of a serious or non-musculoskeletal condition (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.) Diagnosis of cervical spinal stenosis based on CT or MRI imaging Evidence of cervical myelopathy or central nervous system involvement, (e.g., hyperreflexia, intrinsic muscle wasting of the hands, unsteadiness during gait, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, presence of pathologic reflexes (i.e. positive Hoffman's or Babinski reflex). Prior surgery to the neck or thoracic spine Inability to comply with treatment and follow-up schedule
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Fritz
Organizational Affiliation
IHC Health Services, Inc., Dba: TOSH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wilford Hall Medical Center
City
Lackland AFB
State/Province
Texas
ZIP/Postal Code
78235
Country
United States
Facility Name
Intermountain Healthcare, Rehab Agency
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84119
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24405257
Citation
Fritz JM, Thackeray A, Brennan GP, Childs JD. Exercise only, exercise with mechanical traction, or exercise with over-door traction for patients with cervical radiculopathy, with or without consideration of status on a previously described subgrouping rule: a randomized clinical trial. J Orthop Sports Phys Ther. 2014 Feb;44(2):45-57. doi: 10.2519/jospt.2014.5065. Epub 2014 Jan 9.
Results Reference
result

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The Value of Traction in the Treatment of Cervical Radiculopathy

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