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ISRCTN
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ISRCTN74263096
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ClinicalTrials.gov identifier
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Public title
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A Comparison Between Two Physical Therapy Treatment Programs for Subjects with Lumbar Spinal Stenosis (LSS): A Randomized Clinical Trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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FWH20010030H
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Study hypothesis
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Subjects receiving a program that includes manual physical therapy, exercise, and a body weight supported ambulation program will achieve superior outcomes compared to the subjects receiving flexion based exercise, sub-therapeutic ultrasound, and a treadmill walking program without body weight support.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United States of America
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Disease/condition/study domain
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Lumbar Spinal Stenosis
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Participants - inclusion criteria
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1. Age greater than or equal to 50 years and eligible for military health care
2. Magnetic resonance imaging (MRI) findings consistent with LSS (evidence of compression of lumbar spinal nerve root(s) by degenerative lesions of the facet joint, disc, and/or ligamentum flavum)
3. Chief complaint of pain in the low back, buttock and/or lower extremity(s)
4. Rates sitting as a better position with respect to symptom severity than standing or walking
5. Lives within one hour of either Brooke Army Medical Center or Wilford Hall Medical Center
6. Can attend regular physical therapy appointments for six weeks (2 appointments per week) and three examination appointments (baseline, end of treatment, and 1 year after completion of treatment)
7. Sufficient English reading and language skills and mental capability to complete pain and functional assessment questionnaires
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Participants - exclusion criteria
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1. Severe vascular, pulmonary or coronary artery disease which limits ambulation (as determined by the referring physician, the specialist, or the therapist)
2. Other orthopedic conditions or physical impairments of unrelated nature which would limit ambulation or prevent the subject from fully participating in any other aspect of the rehabilitation exercises (as determined by the referring physician, the specialist, or the therapist)
3. Previous spinal surgery
4. History of spinal tumors, spinal infection, or lumbar vertebral fractures other than spondylolisis or spondylolisthesis
5. Inability to have an MRI scan of the lumbar spine. As with any standard MRI scan, the MRI clinic staff will determine if a subject may or may not complete the test. The following conditions may exclude a patient from being able to have the MRI scan: pacemaker, biomedical implants, a history of metal work or hobbies including metal work, cochlear implants, metal in the eye, claustrophobia, obesity (over 440 lbs).
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Anticipated start date
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01/06/2001
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Anticipated end date
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30/01/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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60
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Interventions
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Individualized Rehabilitation Group: Manual physical therapy, exercise, body weight supported treadmill ambulation
Traditional Rehabilitation Group: Flexion exercises, level treadmill ambulation, and placebo ultrasound
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Primary outcome measure(s)
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Global Rating of Change
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Secondary outcome measure(s)
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Modified Oswestry, Treadmill Test, Swiss Spinal Stenosis Scale, NPRS, Patient Specific Functional Scale
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Sources of funding
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Orthopaedic Section of the American Physical Therapy Association ($10,000); US Air Force Surgeons General ($10,000)
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Trial website
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Publications
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2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17047542
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Contact name
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Dr
Julie M
Whitman
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Address
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3485 W 115th Ave
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City/town
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Westminster
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Zip/Postcode
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80031
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Country
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United States of America
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Email
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whitmanjm@bigfoot.com
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Sponsor
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Wilford Hall Medical Center (USA)
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Address
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59 CRES
2200 Bergquist Drive, Bld 4430
Lackland AFB
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City/town
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San Antonio
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Zip/Postcode
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TX 78236
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Country
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United States of America
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Tel
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+1 210 292 7924
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Fax
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+1 210 292 7121
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Email
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joseph.schmelz@lackland.af.mil
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Date applied
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11/10/2005
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Last edited
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16/08/2011
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Date ISRCTN assigned
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25/10/2005
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