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Completed

NCT Number: NCT00979108

The Value of Traction in the Treatment of Cervical Radiculopathy

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Wilford Hall Medical Center, Lackland Air Force Base, Texas, United States

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About this study

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.)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical therapy rehabilitation

Other

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 names: Saunders 3D Active Trac

Primary outcomes

  1. Neck Disability Questionnaire

    Time frame: Baseline, 4 weeks, 6 months, 1year

Secondary outcomes

  1. Global Rating of Change

    Time frame: Baseline, 4 weeks, 6 months, 1 year

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Collaborators

  • 59th Medical Wing
  • Empi, A DJO Company
  • University of Utah

Registry information

Official study title

The Value of Mechanical Traction in the Treatment of Cervical Radiculopathy

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Sep 17, 2009
Registry last updated
Nov 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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