At a glance
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A Comparison of the Long Term Outcomes of Prolotherapy Versus Interlaminar Epidural Steroid Injections (ESI) for Lumbar Pain Radiating to the Leg
In Brief
A Phase 4 clinical trial evaluating prolotherapy solution of 20% dextrose and Epidural Steroid Injection for Sciatica and 2 related conditions. Completed, enrolled 110 participants across 1 site.
Detailed Summary
The hypothesis is that in the treatment of low back pain (LBP) radiating to the leg, the long-term results of prolotherapy are more effective than those of the current conventional treatment: epidural steroid injections (ESI). This research will examine the efficacy of prolotherapy injections versus epidural steroid injections for the treatment of low back pain radiating to the leg. This is a randomized, unblinded study, in which patients seen in the principle investigator's pain clinic will be randomly divided to receive treatments from either the experimental, prolotherapy group, or the active control, ESI group.
Study Details
Timeline
Interventions
After verifying the anatomy of the lumbosacral spine under ultrasound, a 9cm 22 gauge needle will be used to inject the prolotherapy solution to each of the points specified. In order to view the needle under ultrasound, a needle at least as thick as 22G is required. In order for the prolotherapy injections to be safe, bone must be contacted in order to avoid nerve damage. At each point a total of 1cc prolotherapy solution will be injected.
Prior to the epidural injection a local anaesthetic solution of 1% lidocaine will be injected into the relevant subcutaneous and ligamentous interlaminar space. The injectant solution will be comprised of 80mg methylprednisolone combined with 10mg (2cc) 0.5% bupivicaine. The resulting 4cc will be diluted with another 4cc of normal saline giving a total volume of 8cc. A loss of resistance technique will be used and radiocontrast dye will be injected to verify the placement of the needle prior to injecting the steroid solution.