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

NCT00786981 | Completed

• 1 other identifier: FP-36472
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 4

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.

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in patient-reported pain

  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 satisfaction

  10 weeks, 6 months, 12 months

Study Arms (2)

Epidural steroid injection and physical therapy

OTHER

Other: Epidural steroid injection plus physical therapy

Epidural steroid injection

OTHER

Other: Epidural steroid injection

Interventions

Epidural steroid injection plus physical therapy OTHER

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 and physical therapy

Epidural steroid injection OTHER

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

Epidural steroid injection

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Franklin Pierce University: lead
• University of Colorado, Denver: collaborator

Study Sites (4)

Colorado University

Denver, Colorado, United States

Location

Illinois Neurological Institute at OSF

Peoria, Illinois, 61637, United States

Location

Keesler Air Force Base

Keesler Air Force Base, Mississippi, 39564, United States

Location

Hawkins Foundation

Greenville, South Carolina, 29615, United States

Location

Related Publications (1)

• 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.

  PMID: 30703349 DERIVED

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 5, 2008
• First Posted: November 6, 2008
• Study Start: April 1, 2009
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 31, 2019

Record last verified: 2019-07

Locations

US (4)