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

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hadassah Medical Organization
• Collaborator: Reuth Rehabilitation Hospital
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Pain radiating down one or both legs or to the groin of at least 12 weeks' duration

• Patients with disc lesions with radiating pain to the leg(s)

• Mild spinal stenosis

Exclusion Criteria:

• History of back surgery

• Recent history (less than 2 years) of active malignancy

• Recent fracture in the lumbar spine or pelvis of less than 12 months

• Active locus of infection in the body

• Coagulation disorders, and current anticoagulation therapy, excluding aspirin

• Chronic medication with corticosteroids and NSAIDS (which are said to possibly neutralise the effect of prolotherapy) - the latter must be stopped 24 hours prior to the first treatment session

• Recent injection of cortisone for back pain or any other pathology elsewhere in the body- patients must wait 2 weeks before commencement of the study

• Concurrent significant depressive illness or evidence of catastrophisation, fibromyalgia

• Concurrent history of active autoimmune disease or inflammatory joint disease evidence of a peripheral neuropathy

NOTE:

If any of the above illnesses appear during the time of the treatment in any patient, the patient will be withdrawn from the trial as treatment may be detrimental to his or her health. In addition, follow-up is not relevant to compare a diseased patient with any of the above with patients who are free of the above illnesses.