Contact information
Type
Scientific
Primary contact
Dr Julie M Whitman
ORCID ID
Contact details
3485 W 115th Ave
Westminster
80031
United States of America
whitmanjm@bigfoot.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
FWH20010030H
Study information
Scientific title
Acronym
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Lumbar Spinal Stenosis
Intervention
Individualized Rehabilitation Group: Manual physical therapy, exercise, body weight supported treadmill ambulation
Traditional Rehabilitation Group: Flexion exercises, level treadmill ambulation, and placebo ultrasound
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Global Rating of Change
Secondary outcome measures
Modified Oswestry, Treadmill Test, Swiss Spinal Stenosis Scale, NPRS, Patient Specific Functional Scale
Overall trial start date
01/06/2001
Overall trial end date
30/01/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant 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).
Recruitment start date
01/06/2001
Recruitment end date
30/01/2005
Locations
Countries of recruitment
United States of America
Trial participating centre
3485 W 115th Ave
Westminster
80031
United States of America
Sponsor information
Organisation
Wilford Hall Medical Center (USA)
Sponsor details
59 CRES
2200 Bergquist Drive
Bld 4430
Lackland AFB
San Antonio
TX 78236
United States of America
+1 210 292 7924
joseph.schmelz@lackland.af.mil
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Orthopaedic Section of the American Physical Therapy Association ($10,000); US Air Force Surgeons General ($10,000)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17047542
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22749295
Publication citations
-
Results
Whitman JM, Flynn TW, Childs JD, Wainner RS, Gill HE, Ryder MG, Garber MB, Bennett AC, Fritz JM, A comparison between two physical therapy treatment programs for patients with lumbar spinal stenosis: a randomized clinical trial., Spine, 2006, 31, 22, 2541-2549, doi: 10.1097/01.brs.0000241136.98159.8c.
-
Results
Cleland JA, Whitman JM, Houser JL, Wainner RS, Childs JD, Psychometric properties of selected tests in patients with lumbar spinal stenosis., Spine J, 2012, 12, 10, 921-931, doi: 10.1016/j.spinee.2012.05.004.