Comparison of the Order of Treatment in Lumbar Spinal Stenosis

A Randomized Trial in Patients With Lumbar Spinal Stenosis, Comparing the Order of Treatment With Epidural Corticosteroid Injections and Physical Therapy

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.

Study Overview

• Status: Withdrawn
• Conditions: Lumbar Spinal Stenosis
• Intervention / Treatment: Other: physical therapy; Procedure: lumbar interlaminar epidural steroid injection; Drug: epidural steroid injection

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Atlanta Veterans Affairs Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Physical Therapy first; patients will undergo physical therapy 3-4 sessions followed by lumbar interlaminar epidural steroid injection	Other: physical therapy; physical therapy consisting of core strengthening, low back stretching and range of motion 3 sessions; Procedure: lumbar interlaminar epidural steroid injection; single lumbar interlaminar epidural steroid injection; Drug: epidural steroid injection; Dexamethasone 10mg or Depomedrol 40mg, together with Bupivacaine 0.25% (for 3-5mL total injectate volume)
Active Comparator: lumbar epidural steroid first; lumbar interlaminar epidural steroid injection followed by patients will undergo physical therapy 3-4 sessions	Other: physical therapy; physical therapy consisting of core strengthening, low back stretching and range of motion 3 sessions; Procedure: lumbar interlaminar epidural steroid injection; single lumbar interlaminar epidural steroid injection; Drug: epidural steroid injection; Dexamethasone 10mg or Depomedrol 40mg, together with Bupivacaine 0.25% (for 3-5mL total injectate volume)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry disability Index	measurements will be done at baseline, week 4 (1-2 weeks after intervention), 6 months, and at 1 year	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analog scale	measurements will be done at baseline, week 4 (1-2 weeks after intervention), 6 months, and at 1 year	1 year

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Study Director: Hassan Monfared, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2014
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: March 27, 2014
• First Submitted That Met QC Criteria: April 1, 2014
• First Posted (Estimate): April 4, 2014

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 17, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: IRB00061868