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

Primary Purpose

Lumbar Spinal Stenosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Epidural steroid injection plus physical therapy
Epidural steroid injection
Sponsored by
Franklin Pierce University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Colorado University
  • Illinois Neurological Institute at OSF
  • Keesler Air Force Base
  • Hawkins Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Epidural steroid injection and physical therapy

Epidural steroid injection

Arm Description

Outcomes

Primary Outcome Measures

The primary outcome of interest will be change in disability as measured by the Modified Oswestry Disability Index (OSW).

Secondary Outcome Measures

Change in patient-reported pain
Change in Functional Limitations
Change in psychosocial evaluation
Change in patient satisfaction

Full Information

First Posted
November 5, 2008
Last Updated
July 30, 2019
Sponsor
Franklin Pierce University
Collaborators
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT00786981
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Franklin Pierce University
Collaborators
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epidural steroid injection and physical therapy
Arm Type
Other
Arm Title
Epidural steroid injection
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Epidural steroid injection plus physical therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Epidural steroid injection
Intervention Description
Patients in the ESI Group will be treated with up to 3 epidural steroid injections, educational support, and general care by the treating physician.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change in patient-reported pain
Time Frame
10 weeks, 6 months, 12 months
Title
Change in Functional Limitations
Time Frame
10 weeks, 6 months, 12 months
Title
Change in psychosocial evaluation
Time Frame
10 weeks, 6 months, 12 months
Title
Change in patient satisfaction
Time Frame
10 weeks, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Colorado University
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Illinois Neurological Institute at OSF
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Keesler Air Force Base
City
Keesler Air Force Base
State/Province
Mississippi
ZIP/Postal Code
39564
Country
United States
Facility Name
Hawkins Foundation
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30703349
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.
Results Reference
derived

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

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