The Value of Traction in the Treatment of Cervical Radiculopathy

Phase 3

Completed

• Conditions: Intervertebral Disk Displacement; Neck Pain; Spinal Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Radiculopathy
• Interventions: Other: Physical therapy rehabilitation

• Registration Number: NCT00979108
• Lead Sponsor: Intermountain Health Care, Inc.

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:

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.)

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-09-16
• Study First Submitted QC: 2009-09-16
• Study First Posted: 2009-09-17
• Primary Completion: 2012-03
• Study Completion: 2013-01
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-14
• Last Update Posted: 2014-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard exercise	Physical therapy rehabilitation	Subjects will be instructed in neck and postural exercises.
Over-door traction and exercise.	Physical therapy rehabilitation	Subjects will receive traction utilizing an over-the-door traction unit in addition to neck and postural exercises.
Mechanical traction and exercise	Physical therapy rehabilitation	Mechanical cervical traction will be utilized in addition to neck and postural exercises.

Primary Outcome Measures

Name	Time	Method
Neck Disability Questionnaire	Baseline, 4 weeks, 6 months, 1year

Secondary Outcome Measures

Name	Time	Method
Global Rating of Change	Baseline, 4 weeks, 6 months, 1 year

Trial Locations

Locations (2)

Wilford Hall Medical Center; 🇺🇸 Lackland AFB, Texas, United States

Intermountain Healthcare, Rehab Agency; 🇺🇸 Salt Lake City, Utah, United States