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

NCT01934868 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-06-29

No results posted yet for this study

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.

Conditions

  • Sciatica
  • Spinal Stenosis of Lumbar Region
  • Degeneration 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.

Sponsors & Collaborators

  • Reuth Rehabilitation Hospital

    collaborator OTHER

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Osnat Wende, MD · Hadassah Medical Organization

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-12-01
Primary Completion
2023-04-01
Completion
2023-04-10

Countries

  • Israel

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 NCT01934868 on ClinicalTrials.gov