Status:
COMPLETED
The Value of Traction in Treatment of Lumbar Radiculopathy
Lead Sponsor:
Intermountain Health Care, Inc.
Collaborating Sponsors:
University of Utah
59th Medical Wing
Conditions:
Sciatica
Radiculopathy
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
Despite the opinions of clinical experts that patients who might benefit from traction may represent distinct sub-groups of patients, most studies have not attempted to narrow their inclusion criteria...
Eligibility Criteria
Inclusion
- 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:
- Positive ipsilateral or contralateral straight leg raise test (reproduction of leg symptoms with straight leg raise \< 70 degrees)
- Sensory deficit to pinprick on the ipsilateral lower extremity
- Diminished strength of a myotome (hip flexion, knee extension, ankle dorsiflexion, great toe extension, or ankle eversion) of the ipsilateral lower extremity
- Diminished lower extremity reflex (Quadriceps or Achilles) of the symptomatic lower extremity
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00942227
Start Date
July 1 2009
End Date
December 1 2012
Last Update
January 14 2013
Active Locations (1)
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1
Intermountain Healthcare, Rehab Agency
Salt Lake City, Utah, United States, 84119