Musculoskeletal Diseases Clinical Trial
Official title:
The Value of Traction in Treatment of Lumbar Radiculopathy.
The purpose of this study is to determine the effectiveness of adding mechanical traction to standard physical therapy treatments for patients with low back pain.
Status | Completed |
Enrollment | 120 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Chief complaint of pain and/or paresthesia in the lumbar spine with a distribution of symptoms that has extended distal to the gluteal fold on at least one lower extremity within the past 24 hours based on the patient's self-report. - Oswestry disability score of at least 20% - Age at least 18 years and less than 60 years - At least one of the following signs of nerve root compression: 1. Positive ipsilateral or contralateral straight leg raise test (reproduction of leg symptoms with straight leg raise < 70 degrees) 2. Sensory deficit to pinprick on the ipsilateral lower extremity 3. Diminished strength of a myotome (hip flexion, knee extension, ankle dorsiflexion, great toe extension, or ankle eversion) of the ipsilateral lower extremity 4. Diminished lower extremity reflex (Quadriceps or Achilles) of the symptomatic lower extremity Exclusion Criteria: - Red flags noted in the patient's general medical screening questionnaire (i.e., tumor, metabolic diseases, RA, osteoporosis, spinal compression fracture, prolonged history of steroid use, etc.) - Evidence of central nervous system involvement, to include symptoms of cauda equina syndrome (i.e., loss of bowel/bladder control or saddle region paresthesia) or the presence of pathological reflexes (i.e., positive Babinski) - Patient reports the complete absence of low back and leg symptoms when seated - Recent surgery (< 6 months) to the lumbar spine or buttocks, or any fusion surgery of the lumbar spine or pelvis - Recent (< 2 weeks) epidural steroid injection for low back and/or leg pain - Current pregnancy - Inability to comply with the treatment schedule |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
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,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oswestry Disability Index | Baseline, 6 weeks, 6 months, 1year | No | |
Secondary | Global Rating of Change | Baseline, 6 weeks, 6 months, 1 year | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
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