Back to resultsComparison of the Order of Treatment in Lumbar Spinal Stenosis
Primary Purpose
Lumbar Spinal Stenosis
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
physical therapy
lumbar interlaminar epidural steroid injection
epidural steroid injection
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Spinal Stenosis
Eligibility Criteria
Inclusion Criteria: chronic low back pain (at least 3 months in duration), a Visual Analogue Scale (VAS) greater than 30 (on a 100 point scale), between the ages of 18 to 80 years, either without radiating leg pain (below the knees) or with low back and/or buttock pain greater than leg pain (in which case the VAS for leg pain must be 20 or less), ability to read English and complete the assessment instruments, and diagnosis of lumbar spinal stenosis by a board certified radiologist or a board certified physiatrist either by magnetic resonance imaging (MRI) or computed-tomography (CT) that has previously been done as part of a normal course of patients medical treatment. All underlying etiology or diagnoses that are the source for lumbar spinal stenosis will be recorded (e.g. spondylolisthesis, herniated or degenerative discs, spondylosis).
-
Exclusion Criteria:
- history of lumbar surgery, acute disc herniation as reported on a radiologic imaging report, acute or severe chronic illness that are unstable, cognitive impairment which prevents the patient from providing accurate data or giving informed consent, neurological conditions (e.g. stroke, Parkinson's, brain injury), lower extremity amputees, fibromyalgia or chronic generalized pain, unstable opioid use or any signs or evidence of alcohol dependence or illicit drug use (as determined by screening questionnaire), clinical suspicion of facet joint-originating back pain or a positive response to prior facet joint block, lumbar epidural steroid injections within the last 6 months, uncontrolled psychiatric disorders, serious concomitant medical illness (e.g. acute heart failure, acute renal failure) or severe pain that may impair patient's ability to participate in physical therapy exercises or pain that is deemed so severe such that withholding of an ESI until after completion of the PT exercises is seen as causing unreasonable suffering to the patient, and conditions that would prevent the patient from undergoing fluoroscopy (e.g. pregnancy).
Sites / Locations
- Atlanta Veterans Affairs Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Physical Therapy first
lumbar epidural steroid first
Arm Description
patients will undergo physical therapy 3-4 sessions followed by lumbar interlaminar epidural steroid injection
lumbar interlaminar epidural steroid injection followed by patients will undergo physical therapy 3-4 sessions
Outcomes
Primary Outcome Measures
Oswestry disability Index
measurements will be done at baseline, week 4 (1-2 weeks after intervention), 6 months, and at 1 year
Secondary Outcome Measures
visual analog scale
measurements will be done at baseline, week 4 (1-2 weeks after intervention), 6 months, and at 1 year
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02103543
Brief Title
Comparison of the Order of Treatment in Lumbar Spinal Stenosis
Official Title
A Randomized Trial in Patients With Lumbar Spinal Stenosis, Comparing the Order of Treatment With Epidural Corticosteroid Injections and Physical Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of recruitment
Study Start Date
January 2014 (Anticipated)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients with back pain with spinal stenosis of the lower back will be asked to volunteer for this research study. These patients don't need immediate surgery for this problem. Treatment of this kind of back pain with spinal stenosis usually includes physical therapy exercises and steroid injections. Both treatments are usually helpful in patients with back pain with spinal stenosis. However, physicians and other healthcare providers don't know which treatment is better to give first. The purpose of this research is to answer that question. Patients enrolled in this study will receive both treatments: physical therapy (PT) and a steroid injection ("shot"). However, patients may get the shot first followed by PT, or they may have PT first, followed by the shot. Their time in this study will last up to 6 months, and there will be five outcome measurements (via visits or telephone). All study visits will take place at the Atlanta VA Medical Center (Atlanta VA). Investigators hope to enroll about 120 subjects from the Atlanta VA. Enrolled patients will be randomized using a randomization computer program.
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
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical Therapy first
Arm Type
Active Comparator
Arm Description
patients will undergo physical therapy 3-4 sessions followed by lumbar interlaminar epidural steroid injection
Arm Title
lumbar epidural steroid first
Arm Type
Active Comparator
Arm Description
lumbar interlaminar epidural steroid injection followed by patients will undergo physical therapy 3-4 sessions
Intervention Type
Other
Intervention Name(s)
physical therapy
Intervention Description
physical therapy consisting of core strengthening, low back stretching and range of motion 3 sessions
Intervention Type
Procedure
Intervention Name(s)
lumbar interlaminar epidural steroid injection
Intervention Description
single lumbar interlaminar epidural steroid injection
Intervention Type
Drug
Intervention Name(s)
epidural steroid injection
Intervention Description
Dexamethasone 10mg or Depomedrol 40mg, together with Bupivacaine 0.25% (for 3-5mL total injectate volume)
Primary Outcome Measure Information:
Title
Oswestry disability Index
Description
measurements will be done at baseline, week 4 (1-2 weeks after intervention), 6 months, and at 1 year
Time Frame
1 year
Secondary Outcome Measure Information:
Title
visual analog scale
Description
measurements will be done at baseline, week 4 (1-2 weeks after intervention), 6 months, and at 1 year
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: chronic low back pain (at least 3 months in duration), a Visual Analogue Scale (VAS) greater than 30 (on a 100 point scale), between the ages of 18 to 80 years, either without radiating leg pain (below the knees) or with low back and/or buttock pain greater than leg pain (in which case the VAS for leg pain must be 20 or less), ability to read English and complete the assessment instruments, and diagnosis of lumbar spinal stenosis by a board certified radiologist or a board certified physiatrist either by magnetic resonance imaging (MRI) or computed-tomography (CT) that has previously been done as part of a normal course of patients medical treatment. All underlying etiology or diagnoses that are the source for lumbar spinal stenosis will be recorded (e.g. spondylolisthesis, herniated or degenerative discs, spondylosis).
-
Exclusion Criteria:
history of lumbar surgery, acute disc herniation as reported on a radiologic imaging report, acute or severe chronic illness that are unstable, cognitive impairment which prevents the patient from providing accurate data or giving informed consent, neurological conditions (e.g. stroke, Parkinson's, brain injury), lower extremity amputees, fibromyalgia or chronic generalized pain, unstable opioid use or any signs or evidence of alcohol dependence or illicit drug use (as determined by screening questionnaire), clinical suspicion of facet joint-originating back pain or a positive response to prior facet joint block, lumbar epidural steroid injections within the last 6 months, uncontrolled psychiatric disorders, serious concomitant medical illness (e.g. acute heart failure, acute renal failure) or severe pain that may impair patient's ability to participate in physical therapy exercises or pain that is deemed so severe such that withholding of an ESI until after completion of the PT exercises is seen as causing unreasonable suffering to the patient, and conditions that would prevent the patient from undergoing fluoroscopy (e.g. pregnancy).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Monfared, MD
Organizational Affiliation
Emory University
Official's Role
Study Director
Facility Information:
Facility Name
Atlanta Veterans Affairs Medical Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Order of Treatment in Lumbar Spinal Stenosis
We'll reach out to this number within 24 hrs