The Value of Traction in the Treatment of Cervical Radiculopathy

The Value of Mechanical 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.

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Diseases; Neuromuscular Diseases; Spinal Diseases; Neck Pain; Radiculopathy; Intervertebral Disk Displacement
• Intervention / Treatment: Other: Physical therapy rehabilitation; Other: Physical therapy rehabilitation; Other: Physical therapy rehabilitation

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 Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Lackland AFB, Texas, United States, 78235
      • Wilford Hall Medical Center
  • Utah
    • Salt Lake City, Utah, United States, 84119
      • Intermountain Healthcare, Rehab Agency

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard exercise; Subjects will be instructed in 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; 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.; 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; 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; 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.; Other: Physical therapy rehabilitation; Subjects will be instructed 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; 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.; Other: Physical therapy rehabilitation; Subjects will be instructed in neck and postural exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Neck Disability Questionnaire	Baseline, 4 weeks, 6 months, 1year

Secondary Outcome Measures

Outcome Measure	Time Frame
Global Rating of Change	Baseline, 4 weeks, 6 months, 1 year

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Collaborators: 59th Medical Wing; University of Utah; Empi, A DJO Company
• Investigators: Principal Investigator: Julie Fritz, IHC Health Services, Inc., Dba: TOSH

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: September 16, 2009
• First Submitted That Met QC Criteria: September 16, 2009
• First Posted (Estimate): September 17, 2009

Study Record Updates

• Last Update Posted (Estimate): November 17, 2014
• Last Update Submitted That Met QC Criteria: November 14, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Rehabilitation; Physical therapy modalities; Neck pain; Radiculopathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Bone Diseases; Hernia; Intervertebral Disc Displacement; Neck Pain; Radiculopathy; Musculoskeletal Diseases; Spinal Diseases; Neuromuscular Diseases
• Other Study ID Numbers: 1009133