drugset / Trial / NCT02103543

Comparison of the Order of Treatment in Lumbar Spinal Stenosis

NCT02103543

Withdrawn Emory University
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 10 mg Other
Subject Methylprednisolone Other / unclassified 40 mg Other
Background Bupivacaine Other / unclassified 0.25 % Other