Neck Pain Clinical Trial
Official title:
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.
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Wilford Hall Medical Center | Lackland AFB | Texas |
United States | Intermountain Healthcare, Rehab Agency | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Intermountain Health Care, Inc. | Empi, A DJO Company, University of Utah, Wilford Hall Medical Center |
United States,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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