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Treatment of Discogenic Back Pain

NCT02089139 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-09-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Gelscom SAS

    collaborator INDUSTRY

  • University Hospital, Limoges

    lead OTHER

Principal Investigators

  • CAIRE François, MD · University Hospital, Limoges

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2018-05-31
Completion
2018-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02089139 on ClinicalTrials.gov