NCT02103543

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2014-01-01
• Primary completion: 2017-01-01
• Completion: 2017-12-01
• First posted: 2014-04-04
• Last updated: 2017-02-23

Locations

1 site across 1 country: United States