Epidural Steroid Injection Versus Epidural Steroid Injection and Manual Physical Therapy and Exercise in the Management of Lumbar Spinal Stenosis; a Randomized Clinical Trial - Full Text View

Sponsors and Collaborators:	Franklin Pierce University University of Colorado at Denver and Health Sciences Center
Information provided by:	Franklin Pierce University
ClinicalTrials.gov Identifier:	NCT00786981

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

MedlinePlus related topics: Exercise and Physical Fitness Spinal Stenosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment
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

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:

Secondary outcome measures will include patient-reported pain, functional limitations, psychosocial evaluation, and patient satisfaction measures. [ 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 2011
Estimated Primary Completion Date:	September 2010 (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 indentified 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
Denver, Colorado, United States

Sponsors and Collaborators

Franklin Pierce University

University of Colorado at Denver and Health Sciences Center

More Information

No publications provided

Responsible Party:	Franklin Pierce University ( Josh Cleland, PT, PhD )
Study ID Numbers:	FP-36472
Study First Received:	November 5, 2008
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00786981 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Spinal Diseases
Pathological Conditions, Anatomical
Musculoskeletal Diseases

Constriction, Pathologic
Bone Diseases
Spinal Stenosis

Additional relevant MeSH terms:

Spinal Diseases
Pathological Conditions, Anatomical
Musculoskeletal Diseases

Constriction, Pathologic
Bone Diseases
Spinal Stenosis

ClinicalTrials.gov processed this record on May 07, 2009