Epidural Steroid Injection Versus Epidural Steroid Injection and Manual Physical Therapy and Exercise in the Management of Lumbar Spinal Stenosis

Not Applicable

Completed

• Conditions: Lumbar Spinal Stenosis
• Interventions: Other: Epidural steroid injection plus physical therapy; Other: Epidural steroid injection

• Registration Number: NCT00786981
• Lead Sponsor: Franklin Pierce University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-05
• Study First Submitted QC: 2008-11-05
• Study First Posted: 2008-11-06
• Study Start: 2009-04
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural steroid injection and physical therapy	Epidural steroid injection plus physical therapy	-
Epidural steroid injection	Epidural steroid injection	-

Primary Outcome Measures

Name	Time	Method
The primary outcome of interest will be change in disability as measured by the Modified Oswestry Disability Index (OSW).	10 weeks, 6 months, 12 months

Secondary Outcome Measures

Name	Time	Method
Change in patient satisfaction	10 weeks, 6 months, 12 months
Change in Functional Limitations	10 weeks, 6 months, 12 months
Change in psychosocial evaluation	10 weeks, 6 months, 12 months
Change in patient-reported pain	10 weeks, 6 months, 12 months

Trial Locations

Locations (4)

Illinois Neurological Institute at OSF; 🇺🇸 Peoria, Illinois, United States

Keesler Air Force Base; 🇺🇸 Keesler Air Force Base, Mississippi, United States

Colorado University; 🇺🇸 Denver, Colorado, United States

Hawkins Foundation; 🇺🇸 Greenville, South Carolina, United States