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
Sponsor:
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
  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:


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:

  1. 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?
  2. Is cervical traction a critical component of the treatment necessary to maximize outcomes for patients in this subgroup?
  3. 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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Intermountain Health Care, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Radiculopathy
Neck Pain
Musculoskeletal Diseases
Neuromuscular Diseases
Intervertebral Disc Displacement
Peripheral Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Bone Diseases
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 01, 2014