Comparison of the Order of Treatment in Lumbar Spinal Stenosis

NCT ID: NCT02103543

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-12-31

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.

Conditions

Lumbar Spinal Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physical Therapy first

patients will undergo physical therapy 3-4 sessions followed by lumbar interlaminar epidural steroid injection

Group Type: ACTIVE_COMPARATOR

physical therapy

Intervention Type: OTHER

physical therapy consisting of core strengthening, low back stretching and range of motion 3 sessions

lumbar interlaminar epidural steroid injection

Intervention Type: PROCEDURE

single lumbar interlaminar epidural steroid injection

epidural steroid injection

Intervention Type: DRUG

Dexamethasone 10mg or Depomedrol 40mg, together with Bupivacaine 0.25% (for 3-5mL total injectate volume)

lumbar epidural steroid first

lumbar interlaminar epidural steroid injection followed by patients will undergo physical therapy 3-4 sessions

Group Type: ACTIVE_COMPARATOR

physical therapy

Intervention Type: OTHER

physical therapy consisting of core strengthening, low back stretching and range of motion 3 sessions

lumbar interlaminar epidural steroid injection

Intervention Type: PROCEDURE

single lumbar interlaminar epidural steroid injection

epidural steroid injection

Intervention Type: DRUG

Dexamethasone 10mg or Depomedrol 40mg, together with Bupivacaine 0.25% (for 3-5mL total injectate volume)

Interventions

physical therapy

physical therapy consisting of core strengthening, low back stretching and range of motion 3 sessions

Intervention Type: OTHER

lumbar interlaminar epidural steroid injection

single lumbar interlaminar epidural steroid injection

Intervention Type: PROCEDURE

epidural steroid injection

Dexamethasone 10mg or Depomedrol 40mg, together with Bupivacaine 0.25% (for 3-5mL total injectate volume)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

-

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Hassan Monfared MD

Assistant Professor, Program Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hassan Monfared, MD

Role: STUDY_DIRECTOR

Emory University

Locations

Atlanta Veterans Affairs Medical Center

Decatur, Georgia, United States

Countries

United States

Other Identifiers

IRB00061868

Identifier Type: -

Identifier Source: org_study_id