Clinical trial NCT00979108: The Value of Traction in the Treatment of Cervical Radiculopathy
Official title: The Value of Mechanical Traction in the Treatment of Cervical Radiculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Radiculopathy
Neck Pain
Spinal Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Intervertebral Disk Displacement
Keywords: Radiculopathy
Neck pain
Physical therapy modalities
Rehabilitation
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: University of Utah
name: 59th Medical Wing
name: Empi, A DJO Company
First posted: 2009-09-17
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.)

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

Primary outcomes:
measure: Neck Disability Questionnaire
timeFrame: Baseline, 4 weeks, 6 months, 1year
Secondary outcomes:
measure: Global Rating of Change
timeFrame: Baseline, 4 weeks, 6 months, 1 year
Other outcomes:
Locations:
city: Lackland AFB
country: United States
facility: Wilford Hall Medical Center
state: Texas
city: Salt Lake City
country: United States
facility: Intermountain Healthcare, Rehab Agency
state: Utah
Study officials:
affiliation: IHC Health Services, Inc., Dba: TOSH
name: Julie Fritz
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.