NCT02089139

Treatment of Discogenic Back Pain

Intradiscal Injection of Gelified Ethanol for the Treatment of Discogenic Back Pain

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University Hospital, Limoges · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Discogenic Back Pain

Interventions

Type	Name	Description
DEVICE	Discogel	DiscoGel is a sterile viscous solution containing ethyl alcohol, cellulose derivative product and tungsten (radio-opaque element)
OTHER	conventional treatment	Conventional treatment based on current guidelines regarding the management of discogenic low back pain, including but not limited to: * medications (analgesics, NSAIDs, muscle relaxants), * physical therapy, * manual techniques, * transcutaneous electrical nerve stimulation (TENS), * blocks

Timeline

• Start date: 2014-05-01
• Primary completion: 2018-05-01
• Completion: 2018-09-01
• First posted: 2014-03-17
• Last updated: 2015-09-11

Locations

1 site across 1 country: France