Epidural Steroid Injection Versus Epidural Steroid Injection and Manual Physical Therapy and Exercise in the Management of Lumbar Spinal Stenosis
This study is currently recruiting participants.
Verified November 2012 by Franklin Pierce University
Sponsor:
Franklin Pierce University
Collaborator:
University of Colorado, Denver
Information provided by (Responsible Party):
Joshua Cleland, DPT, OCS, Franklin Pierce University
ClinicalTrials.gov Identifier:
NCT00786981
First received: November 5, 2008
Last updated: November 29, 2012
Last verified: November 2012
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Purpose
Lumbar spinal stenosis (LSS) is a prevalent and disabling condition in the rapidly growing aging population. People with LSS often have a substantial physical and psychosocial burden as well as significant healthcare costs affecting both the individual and society. It has been reported that patients with LSS over the age of 65 are more likely to undergo spinal surgery than any other condition with an estimated total annual inpatient expense of one billion. Individuals undergoing surgical treatment for LSS tend to be older, therefore operative morbidity and mortality are a particular concern. Functional benefit derived from conservative treatment may increase the health and quality of life for individuals suffering from LSS and avoid or delay the need for surgery in some subjects. As the population continues to age, identifying effective non-surgical treatment options for older patients with LSS is an important research priority. Ultimately, the information gained from this study will help fill a significant void in medical literature regarding non-surgical options for this patient population.
| Condition | Intervention |
|---|---|
|
Lumbar Spinal Stenosis |
Other: Epidural steroid injection plus physical therapy Other: Epidural steroid injection |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Epidural Steroid Injection Versus Epidural Steroid Injection and Manual Physical Therapy and Exercise in the Management of Lumbar Spinal Stenosis; a Randomized Clinical Trial |
Resource links provided by NLM:
Further study details as provided by Franklin Pierce University:
Primary Outcome Measures:
- The primary outcome of interest will be change in disability as measured by the Modified Oswestry Disability Index (OSW). [ Time Frame: 10 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in patient-reported pain [ Time Frame: 10 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
- Change in Functional Limitations [ Time Frame: 10 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
- Change in psychosocial evaluation [ Time Frame: 10 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
- Change in patient satisfaction [ Time Frame: 10 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Epidural steroid injection and physical therapy |
Other: Epidural steroid injection plus physical therapy
Patients in the ESI+PT Group will be treated additionally with a physical therapy program emphasizing lumbar flexion exercises, aerobic and strength/ conditioning exercises, and manual physical therapy as well as receiving up to 3 epidural steroid injection(s) and educational support using The Back Book.
|
| Epidural steroid injection |
Other: Epidural steroid injection
Patients in the ESI Group will be treated with up to 3 epidural steroid injections, educational support, and general care by the treating physician.
|
Eligibility| Ages Eligible for Study: | 50 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Lumbar spinal stenosis unidentified by MRI or CT scan and interpreted by a radiologist independent of the study. The criteria of Boden et al will be used to define LSS on MRI: non-discogenic loss of signal in the epidural fat with compression of neural tissues.
- Chief complaint of pain in the low back, buttock, and/or lower extremity. The patient must have LE symptoms consistent with neurogenic claudiation.
- Patient-reported inability to walk greater than ¼ mile due to lower extremity pain and/or cramping.
- Rates sitting as a better position with respect to symptom severity compared to standing or walking.
- Consent of the patient to undergo education, epidural steroid injection(s), and attend specified physical therapy sessions.
- Individuals with no language barrier, that are cooperative, have transportation to the Spine Center, and who sign an informed consent form.
- Age greater than or equal to 50 years.
Exclusion Criteria:
- Patients with organic brain syndrome or dementia.
- Severe vascular, pulmonary or coronary artery disease which limits ambulation.
- Recent myocardial infarction (within last 6 months).
- Spondylolisthesis requiring surgical fusion (i.e., greater than 5mm of slippage).
- Previous spinal surgery that included fusion of two or more vertebrae.
- Severe osteoporosis as defined by multiple compression fractures or a fracture at the same level as the stenosis.
- Metastatic cancer.
- Excessive alcohol consumption or evidence of non-prescribed or illegal drug use.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786981
Contacts
| Contact: Joshua Cleland, PT, PhD | 603.785.5576 | joshcleland@comcast.net |
| Contact: Amy Hammerich, PT, DPT | 303-964-5796 | ahammeri@regis.edu |
Locations
| United States, Colorado | |
| Colorado University | Recruiting |
| Denver, Colorado, United States | |
| Contact: Paul Mintken 303-881-1569 Paul.Mintken@UCHSC.edu | |
Sponsors and Collaborators
Franklin Pierce University
University of Colorado, Denver
More Information
No publications provided
| Responsible Party: | Joshua Cleland, DPT, OCS, Professor, Franklin Pierce University |
| ClinicalTrials.gov Identifier: | NCT00786981 History of Changes |
| Other Study ID Numbers: | FP-36472 |
| Study First Received: | November 5, 2008 |
| Last Updated: | November 29, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Constriction, Pathologic Spinal Stenosis Pathological Conditions, Anatomical |
Spinal Diseases Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013