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A Comparison Between Two Physical Therapy Treatment Programs for Subjects with Lumbar Spinal Stenosis (LSS): A Randomized Clinical Trial
ISRCTN ISRCTN74263096
DOI 10.1186/ISRCTN74263096
ClinicalTrials.gov identifier
EudraCT number
Public title A Comparison Between Two Physical Therapy Treatment Programs for Subjects with Lumbar Spinal Stenosis (LSS): A Randomized Clinical Trial
Scientific title
Acronym N/A
Serial number at source FWH20010030H
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United States of America
Disease/condition/study domain Lumbar Spinal Stenosis
Participants - inclusion criteria 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
Participants - exclusion criteria 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).
Anticipated start date 01/06/2001
Anticipated end date 30/01/2005
Status of trial Completed
Patient information material
Target number of participants 60
Interventions Individualized Rehabilitation Group: Manual physical therapy, exercise, body weight supported treadmill ambulation

Traditional Rehabilitation Group: Flexion exercises, level treadmill ambulation, and placebo ultrasound
Primary outcome measure(s) Global Rating of Change
Secondary outcome measure(s) Modified Oswestry, Treadmill Test, Swiss Spinal Stenosis Scale, NPRS, Patient Specific Functional Scale
Sources of funding Orthopaedic Section of the American Physical Therapy Association ($10,000); US Air Force Surgeons General ($10,000)
Trial website
Publications 1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17047542
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22749295
Contact name Dr  Julie M  Whitman
  Address 3485 W 115th Ave
  City/town Westminster
  Zip/Postcode 80031
  Country United States of America
  Email whitmanjm@bigfoot.com
Sponsor Wilford Hall Medical Center (USA)
  Address 59 CRES
2200 Bergquist Drive, Bld 4430
Lackland AFB
  City/town San Antonio
  Zip/Postcode TX 78236
  Country United States of America
  Tel +1 210 292 7924
  Fax +1 210 292 7121
  Email joseph.schmelz@lackland.af.mil
Date applied 11/10/2005
Last edited 16/05/2013
Date ISRCTN assigned 25/10/2005
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