A Comparison Between Two Physical Therapy Treatment Programs for Subjects with Lumbar Spinal Stenosis (LSS): A Randomized Clinical Trial
| ISRCTN | ISRCTN74263096 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74263096 |
| Secondary identifying numbers | FWH20010030H |
- Submission date
- 11/10/2005
- Registration date
- 25/10/2005
- Last edited
- 16/05/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Julie M Whitman
Scientific
Scientific
3485 W 115th Ave
Westminster
80031
United States of America
| whitmanjm@bigfoot.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Global Rating of Change |
| Secondary outcome measures | Modified Oswestry, Treadmill Test, Swiss Spinal Stenosis Scale, NPRS, Patient Specific Functional Scale |
| Overall study start date | 01/06/2001 |
| Completion date | 30/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Key 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 |
| Key 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). |
| Date of first enrolment | 01/06/2001 |
| Date of final enrolment | 30/01/2005 |
Locations
Countries of recruitment
- United States of America
Study participating centre
3485 W 115th Ave
Westminster
80031
United States of America
80031
United States of America
Sponsor information
Wilford Hall Medical Center (USA)
Hospital/treatment centre
Hospital/treatment centre
59 CRES
2200 Bergquist Drive, Bld 4430
Lackland AFB
San Antonio
TX 78236
United States of America
| Phone | +1 210 292 7924 |
|---|---|
| joseph.schmelz@lackland.af.mil | |
"ROR" |
https://ror.org/025m0q735 |
Funders
Funder type
Charity
Orthopaedic Section of the American Physical Therapy Association ($10,000); US Air Force Surgeons General ($10,000)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/10/2006 | Yes | No | |
| Results article | results | 01/10/2012 | Yes | No |
