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Comparison of the Order of Treatment in Lumbar Spinal Stenosis

NCT02103543 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-02-23

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Hassan Monfared, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2017-01-31
Completion
2017-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02103543 on ClinicalTrials.gov