Clinical trial NCT00786981: Epidural Steroid Injection Versus Epidural Steroid Injection and Manual Physical Therapy and Exercise in the Management of Lumbar Spinal Stenosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spinal Stenosis
Lead sponsor: Franklin Pierce University
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
First posted: 2008-11-06
Enrollment: 54
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The primary outcome of interest will be change in disability as measured by the Modified Oswestry Disability Index (OSW).
timeFrame: 10 weeks, 6 months, 12 months
Secondary outcomes:
measure: Change in patient-reported pain
timeFrame: 10 weeks, 6 months, 12 months
measure: Change in Functional Limitations
timeFrame: 10 weeks, 6 months, 12 months
measure: Change in psychosocial evaluation
timeFrame: 10 weeks, 6 months, 12 months
measure: Change in patient satisfaction
timeFrame: 10 weeks, 6 months, 12 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Colorado University
state: Colorado
city: Peoria
country: United States
facility: Illinois Neurological Institute at OSF
state: Illinois
city: Keesler Air Force Base
country: United States
facility: Keesler Air Force Base
state: Mississippi
city: Greenville
country: United States
facility: Hawkins Foundation
state: South Carolina
Study officials:
References:
citation: Hammerich A, Whitman J, Mintken P, Denninger T, Akuthota V, Sawyer EE, Hofmann M, Childs JD, Cleland J. Effectiveness of Physical Therapy Combined With Epidural Steroid Injection for Individuals With Lumbar Spinal Stenosis: A Randomized Parallel-Group Trial. Arch Phys Med Rehabil. 2019 May;100(5):797-810. doi: 10.1016/j.apmr.2018.12.035. Epub 2019 Jan 29.