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. (see Contacts and Locations)
Verified July 2013 by Franklin Pierce University
Sponsor:
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: July 8, 2013
Last verified: July 2013
  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:

  1. 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.
  2. Chief complaint of pain in the low back, buttock, and/or lower extremity. The patient must have LE symptoms consistent with neurogenic claudiation.
  3. Patient-reported inability to walk greater than ¼ mile due to lower extremity pain and/or cramping.
  4. Rates sitting as a better position with respect to symptom severity compared to standing or walking.
  5. Consent of the patient to undergo education, epidural steroid injection(s), and attend specified physical therapy sessions.
  6. Individuals with no language barrier, that are cooperative, have transportation to the Spine Center, and who sign an informed consent form.
  7. Age greater than or equal to 50 years.

Exclusion Criteria:

  1. Patients with organic brain syndrome or dementia.
  2. Severe vascular, pulmonary or coronary artery disease which limits ambulation.
  3. Recent myocardial infarction (within last 6 months).
  4. Spondylolisthesis requiring surgical fusion (i.e., greater than 5mm of slippage).
  5. Previous spinal surgery that included fusion of two or more vertebrae.
  6. Severe osteoporosis as defined by multiple compression fractures or a fracture at the same level as the stenosis.
  7. Metastatic cancer.
  8. Excessive alcohol consumption or evidence of non-prescribed or illegal drug use.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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   
United States, Illinois
Illinois Neurological Institute at OSF Recruiting
Peoria, Illinois, United States, 61637
Contact: Cheryl Sparks    309-677-4533    csparks@bradley.edu   
United States, Mississippi
Keesler Air Force Base Recruiting
Keesler AFB, Mississippi, United States, 39564
Contact: John Childs    210-364-7410    childsjd@gmail.com   
United States, South Carolina
Hawkins Foundation Recruiting
Greenville, South Carolina, United States, 29615
Contact: 1. Carlisle Shealy    864-454-7458      
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: July 8, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Stenosis
Bone Diseases
Musculoskeletal Diseases
Pathological Conditions, Anatomical
Spinal Diseases

ClinicalTrials.gov processed this record on October 21, 2014