The Value of Traction in the Treatment of Cervical Radiculopathy

Neck Pain Clinical Trial

Official title:

The Value of Mechanical Traction in the Treatment of Cervical Radiculopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00979108
• Other study ID #: 1009133
• Status: Completed
• Phase: Phase 3
• First received: September 16, 2009
• Last updated: November 14, 2014
• Start date: July 2009
• Est. completion date: January 2013

Study information

• Verified date: November 2014
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Intervertebral Disk Displacement
• Musculoskeletal Diseases
• Neck Pain
• Neuromuscular Diseases
• Radiculopathy
• Spinal Diseases

Intervention

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.
• 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.
• Physical therapy rehabilitation
Subjects will be instructed in neck and postural exercises.

Locations

Country	Name	City	State
United States	Wilford Hall Medical Center	Lackland AFB	Texas
United States	Intermountain Healthcare, Rehab Agency	Salt Lake City	Utah

Sponsors (4)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.	Empi, A DJO Company, University of Utah, Wilford Hall Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 rul — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck Disability Questionnaire		Baseline, 4 weeks, 6 months, 1year	No
Secondary	Global Rating of Change		Baseline, 4 weeks, 6 months, 1 year	No