The Value of Traction in the Treatment of Cervical Radiculopathy

Sponsor

Intermountain Health Care, Inc. (Other)

Overall Status

Completed

CT.gov ID

NCT00979108

Collaborator

University of Utah (Other), 59th Medical Wing (U.S. Fed), Empi, A DJO Company (Industry)

Enrollment

Locations

Arms

42.1

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Radiculopathy Neck Pain Spinal Diseases Musculoskeletal Diseases Neuromuscular Diseases Intervertebral Disk Displacement	Other: Physical therapy rehabilitation Other: Physical therapy rehabilitation Other: Physical therapy rehabilitation	Phase 3

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.)

Study Design

Study Type:

Interventional

Actual Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

The Value of Mechanical Traction in the Treatment of Cervical Radiculopathy

Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Saunders 3D Active Trac

Arm

Intervention/Treatment

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 Names:

Saunders 3D Active Trac

Outcome Measures

Primary Outcome Measures

Neck Disability Questionnaire [Baseline, 4 weeks, 6 months, 1year]

Secondary Outcome Measures

Global Rating of Change [Baseline, 4 weeks, 6 months, 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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