Sciatica Clinical Trial
Official title:
A Comparison of the Long Term Outcomes of Prolotherapy Versus Interlaminar Epidural Steroid Injections (ESI) for Lumbar Pain Radiating to the Leg
Verified date | January 2022 |
Source | Hadassah Medical Organization |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 110 |
Est. completion date | April 10, 2023 |
Est. primary completion date | April 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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NOTE: If any of the above illnesses appear during the time of the treatment in any patient, the patient will be withdrawn from the trial as treatment may be detrimental to his or her health.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. |
Country | Name | City | State |
---|---|---|---|
Israel | Pain Unit, Hadassah Medical Center | Jerusalem |
Lead Sponsor | Collaborator |
---|---|
Hadassah Medical Organization | Reuth Rehabilitation Hospital |
Israel,
Benyamin RM, Manchikanti L, Parr AT, Diwan S, Singh V, Falco FJ, Datta S, Abdi S, Hirsch JA. The effectiveness of lumbar interlaminar epidural injections in managing chronic low back and lower extremity pain. Pain Physician. 2012 Jul-Aug;15(4):E363-404. — View Citation
Bogduk N. On the definitions and physiology of back pain, referred pain, and radicular pain. Pain. 2009 Dec 15;147(1-3):17-9. doi: 10.1016/j.pain.2009.08.020. Epub 2009 Sep 16. No abstract available. — View Citation
Cohen SP, Chen Y, Neufeld NJ. Sacroiliac joint pain: a comprehensive review of epidemiology, diagnosis and treatment. Expert Rev Neurother. 2013 Jan;13(1):99-116. doi: 10.1586/ern.12.148. — View Citation
Iguchi T, Kanemura A, Kasahara K, Kurihara A, Doita M, Yoshiya S. Age distribution of three radiologic factors for lumbar instability: probable aging process of the instability with disc degeneration. Spine (Phila Pa 1976). 2003 Dec 1;28(23):2628-33. doi: 10.1097/01.BRS.0000097162.80495.66. — View Citation
Manchikanti L, Buenaventura RM, Manchikanti KN, Ruan X, Gupta S, Smith HS, Christo PJ, Ward SP. Effectiveness of therapeutic lumbar transforaminal epidural steroid injections in managing lumbar spinal pain. Pain Physician. 2012 May-Jun;15(3):E199-245. — View Citation
Wilkinson HA. Injection therapy for enthesopathies causing axial spine pain and the "failed back syndrome": a single blinded, randomized and cross-over study. Pain Physician. 2005 Apr;8(2):167-73. — View Citation
Yelland MJ, Del Mar C, Pirozzo S, Schoene ML. Prolotherapy injections for chronic low back pain: a systematic review. Spine (Phila Pa 1976). 2004 Oct 1;29(19):2126-33. doi: 10.1097/01.brs.0000141188.83178.b3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of patients suffering from adverse effects | In the event of an adverse effect developing after either of the procedures, this will be reported immediately to the Health Ministry. Number of adverse effects in both groups will be compared. | 1 week after a particular procedure | |
Primary | Numerical Rating Scale | Prior to the first treatment session, patients from both groups will fill out a questionnaire (described later) which will begin with an added item at the beginning: the NRS (numerical rating scale) score. This is to ascertain the intensity of pain he or she suffers in the lower back and or leg. This is a score given between 0 and 10 to estimate the subjective level of pain felt. 10 is a score given to the worst possible imaginable pain, and 0 is no pain at all. At 4 points in time: 1, 3, 6 and 12 months after the last treatment session, patients will be telephoned by a nurse trained in pain to assess pain level according to NRS score. The nurse will be an independent and unbiased investigator. Because patients often suffer from several sorts of pain, it must be stressed to the patients that what is being measured is the very same pain that the patient came to be treated for initially, and not another area which may have developed pain at some later point in time. | 17 months | |
Secondary | Oswestry Back Disability Questionnaire Score | At the same times as being asked about the NRS score, patients will be interviewed and the Oswestry Back Disability Questionnaire will be filled out by an independent investigator who is a nurse trained in the field of pain. She will give a score at each of the above time allotments. The maximal score is 50, and assesses general function and activity of daily living. The higher the score, the worse is the function. Questions asked relate to pain level, ability to wash oneself, lift things, walk, sit, stand, interact socially, travel, and have sexual relations. Patients with a score above 20 or more out of 50 are considered to have a significant disability. | 17 months |
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