Prolotherapy Versus Epidural Steroid Injections (ESI) for Lumbar Pain Radiating to the Leg

PHASE4CompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

December 1, 2013

Primary Completion Date

April 1, 2023

Study Completion Date

April 10, 2023

Conditions
SciaticaSpinal Stenosis of Lumbar RegionDegeneration of Lumbar or Lumbosacral Intervertebral Disc
Interventions
DRUG

prolotherapy solution of 20% dextrose

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.

DRUG

Epidural Steroid Injection

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.

Trial Locations (1)

Unknown

Pain Unit, Hadassah Medical Center, Jerusalem

All Listed Sponsors
collaborator

Reuth Rehabilitation Hospital

OTHER

lead

Hadassah Medical Organization

OTHER

NCT01934868 - Prolotherapy Versus Epidural Steroid Injections (ESI) for Lumbar Pain Radiating to the Leg | Biotech Hunter | Biotech Hunter