Condition category
Musculoskeletal Diseases
Date applied
11/10/2005
Date assigned
25/10/2005
Last edited
16/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

  2. 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.

Additional files

Editorial Notes