The Value of Traction in the Treatment of Cervical Radiculopathy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Intermountain Health Care, Inc..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Intermountain Health Care, Inc.
Collaborators:
University of Utah
Wilford Hall Medical Center
Empi, A DJO Company
Information provided by (Responsible Party):
Shauna Bruun, Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT00979108
First received: September 16, 2009
Last updated: September 11, 2012
Last verified: September 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Radiculopathy Neck Pain Spinal Diseases Musculoskeletal Diseases Neuromuscular Diseases Intervertebral Disk Displacement |
Other: Physical therapy rehabilitation |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | The Value of Mechanical Traction in the Treatment of Cervical Radiculopathy |
Resource links provided by NLM:
MedlinePlus related topics:
Exercise and Physical Fitness
Herniated Disk
Neck Injuries and Disorders
Neuromuscular Disorders
Rehabilitation
Spine Injuries and Disorders
U.S. FDA Resources
Further study details as provided by Intermountain Health Care, Inc.:
Primary Outcome Measures:
- Neck Disability Questionnaire [ Time Frame: Baseline, 4 weeks, 6 months, 1year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Global Rating of Change [ Time Frame: Baseline, 4 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 192 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Standard exercise
Subjects will be instructed in neck and postural exercises.
|
Other: Physical therapy rehabilitation
Subjects will be instructed in neck and postural exercises.
|
|
Experimental: Over-door traction and exercise.
Subjects will receive traction utilizing an over-the-door traction unit in addition to neck and postural exercises.
|
Other: Physical therapy rehabilitation
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.
|
|
Experimental: Mechanical traction and exercise
Mechanical cervical traction will be utilized in addition to neck and postural exercises.
|
Other: Physical therapy rehabilitation
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.
Other Name: Saunders 3D Active Trac
|
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.)
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00979108
Contacts
| Contact: Julie M Fritz, PhD | 801.581.8681 | julie.fritz@hsc.utah.edu |
| Contact: Anne Thackeray, MPH | 801.573.8364 | a.thackeray@utah.edu |
Locations
| United States, Texas | |
| Wilford Hall Medical Center | Recruiting |
| Lackland AFB, Texas, United States, 78235 | |
| Contact: Benjamin Hando, PT, DSc 210-292-2257 benjaminhando@gmail.com | |
| Contact: John D Childs, PhD 210-221-8410 childsjd@sbcglobal.net | |
| United States, Utah | |
| Intermountain Healthcare, Rehab Agency | Recruiting |
| Salt Lake City, Utah, United States, 84119 | |
| Contact: Anne Thackeray, MPH 801-573-8364 a.thackeray@utah.edu | |
| Contact: Gerard P Brennan, PhD 801.314.2529 gerard.brennan@imail.org | |
Sponsors and Collaborators
Intermountain Health Care, Inc.
University of Utah
Wilford Hall Medical Center
Empi, A DJO Company
Investigators
| Principal Investigator: | Julie Fritz | IHC Health Services, Inc., Dba: TOSH |
More Information
No publications provided
| Responsible Party: | Shauna Bruun, Research Operations Coordinator, Intermountain Health Care, Inc. |
| ClinicalTrials.gov Identifier: | NCT00979108 History of Changes |
| Other Study ID Numbers: | 1009133 |
| Study First Received: | September 16, 2009 |
| Last Updated: | September 11, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Intermountain Health Care, Inc.:
|
Radiculopathy Neck pain Physical therapy modalities Rehabilitation |
Additional relevant MeSH terms:
|
Spinal Diseases Neck Pain Intervertebral Disk Displacement Musculoskeletal Diseases Neuromuscular Diseases Radiculopathy Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms Bone Diseases Hernia Pathological Conditions, Anatomical Peripheral Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013