Intradiscal Injection of Gelified Ethanol for the Treatment of Discogenic Back Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Discogenic Back Pain
- Sponsor
- University Hospital, Limoges
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale (VAS)
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
Brief Summary
Discogenic low back pain is the most common form of chronic low back pain. Its diagnosis is mainly based on MR imaging, showing MODIC I or II changes in patients with concordant symptomatology. The treatment of discogenic low back pain is nevertheless difficult: intradiscal therapies (corticosteroids, methylene blue, radiofrequency) have a limited efficacy, and surgical procedures (arthrodesis or disc replacement) are a final recourse with notable risk of side-effects.
In this study, the efficacy of intradiscal injection of gelified ethanol (DiscoGel) in patients with disabling discogenic pain is assessed.
Investigators
Eligibility Criteria
Inclusion Criteria
- •MR imaging : MODIC 1or MODIC 2 changes limited to one single lumbar disc;
- •X rays: normal disc height, no instability;
- •Back pain for at least 3 months, without argument for another etiology;
- •Mean pain on 5 days VAS ≥ 5
Exclusion Criteria
- •age \<18 years or \> 50 ; concomitant radicular pain ;
- •psychiatric pathology that may modify the perception or the evolution of pain;
- •MR imaging: multi-level discopathy, MODIC 3 changes;
- •X ray: loss of disc height \> 50%, segmental instability;
- •previous history of lumbar surgery with or without instrumentation.
Outcomes
Primary Outcomes
Visual Analog Scale (VAS)
Time Frame: Six months after the procedure.
Mean pain intensity score on a Visual Analog Scale (VAS), six months after the procedure.
Secondary Outcomes
- Oswestry Disability Index (ODI)(one month, three months, six months and 1 year after the procedure)
- Euroqol score(month, three months, six months and 1 year after the procedure)
- Visual Analog Scale (VAS),(one month, three months, six months and 1 year after the procedure)