Prolotherapy Versus Epidural Steroid Injections (ESI) for Lumbar Pain Radiating to the Leg (NCT01934868) | Clinical Trial Compass
CompletedPhase 4
Prolotherapy Versus Epidural Steroid Injections (ESI) for Lumbar Pain Radiating to the Leg
Israel110 participantsStarted 2013-12-01
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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If any of the above illnesses appear during the time of the treatment in any patient, the patient will be withdrawn from the trial as treatment may be detrimental to his or her health.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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.