The Value of Traction in the Treatment of Cervical Radiculopathy

NCT ID: NCT00979108

Last Updated: 2014-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2013-01-31

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.)

Conditions

Radiculopathy; Neck Pain; Spinal Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Intervertebral Disk Displacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard exercise

Subjects will be instructed in neck and postural exercises.

Group Type: ACTIVE_COMPARATOR

Physical therapy rehabilitation

Intervention Type: OTHER

Subjects will be instructed in neck and postural exercises.

Over-door traction and exercise.

Subjects will receive traction utilizing an over-the-door traction unit in addition to neck and postural exercises.

Group Type: EXPERIMENTAL

Physical therapy rehabilitation

Intervention Type: OTHER

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.

Mechanical traction and exercise

Mechanical cervical traction will be utilized in addition to neck and postural exercises.

Group Type: EXPERIMENTAL

Physical therapy rehabilitation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Physical therapy rehabilitation

Subjects will be instructed in neck and postural exercises.

Intervention Type: OTHER

Other Intervention Names

Saunders 3D Active Trac

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: collaborator

59th Medical Wing

FED

Sponsor Role: collaborator

Empi, A DJO Company

INDUSTRY

Sponsor Role: collaborator

Intermountain Health Care, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Shauna Bruun

Research Operations Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julie Fritz

Role: PRINCIPAL_INVESTIGATOR

IHC Health Services, Inc., Dba: TOSH

Locations

Wilford Hall Medical Center

Lackland Air Force Base, Texas, United States

Intermountain Healthcare, Rehab Agency

Salt Lake City, Utah, United States

Countries

United States

References

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 rule: a randomized clinical trial. J Orthop Sports Phys Ther. 2014 Feb;44(2):45-57. doi: 10.2519/jospt.2014.5065. Epub 2014 Jan 9.

Reference Type: RESULT

PMID: 24405257 (View on PubMed)

Other Identifiers

1009133

Identifier Type: -

Identifier Source: org_study_id