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

July 30, 2019 updated by: Joshua Cleland, DPT, OCS, Franklin Pierce University

Epidural Steroid Injection Versus Epidural Steroid Injection and Manual Physical Therapy and Exercise in the Management of Lumbar Spinal Stenosis; a Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States
        • Colorado University
    • Illinois
      • Peoria, Illinois, United States, 61637
        • Illinois Neurological Institute at OSF
    • Mississippi
      • Keesler Air Force Base, Mississippi, United States, 39564
        • Keesler Air Force Base
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Hawkins Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
10 weeks, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in patient-reported pain
Time Frame: 10 weeks, 6 months, 12 months
10 weeks, 6 months, 12 months
Change in Functional Limitations
Time Frame: 10 weeks, 6 months, 12 months
10 weeks, 6 months, 12 months
Change in psychosocial evaluation
Time Frame: 10 weeks, 6 months, 12 months
10 weeks, 6 months, 12 months
Change in patient satisfaction
Time Frame: 10 weeks, 6 months, 12 months
10 weeks, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Franklin Pierce University

Collaborators

University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ACTUAL)

December 1, 2018

Study Completion (ACTUAL)

December 1, 2018

Study Registration Dates

First Submitted

November 5, 2008

First Submitted That Met QC Criteria

November 5, 2008

First Posted (ESTIMATE)

November 6, 2008

Study Record Updates

Last Update Posted (ACTUAL)

July 31, 2019

Last Update Submitted That Met QC Criteria

July 30, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FP-36472

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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