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

Lumbar Spinal Stenosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00786981
• Other study ID #: FP-36472
• Status: Completed
• Phase: N/A
• Start date: April 2009
• Est. completion date: December 2018

Study information

• Verified date: July 2019
• Source: Franklin Pierce University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

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
Patients in the ESI Group will be treated with up to 3 epidural steroid injections, educational support, and general care by the treating physician.

Locations

Country	Name	City	State
United States	Colorado University	Denver	Colorado
United States	Hawkins Foundation	Greenville	South Carolina
United States	Keesler Air Force Base	Keesler Air Force Base	Mississippi
United States	Illinois Neurological Institute at OSF	Peoria	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Franklin Pierce University	University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in patient-reported pain		10 weeks, 6 months, 12 months
Secondary	Change in Functional Limitations		10 weeks, 6 months, 12 months
Secondary	Change in psychosocial evaluation		10 weeks, 6 months, 12 months
Secondary	Change in patient satisfaction		10 weeks, 6 months, 12 months