Treatment of Discogenic Back Pain (EGID)

University of Limoges (UL)

Status: Terminated

Conditions: Discogenic Back Pain

Treatments: Other: conventional treatment; Device: Discogel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02089139

I13009

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

DISCOGEL

Experimental group

Description:

Percutaneous intradiscal injection of Discogel

Treatment:

Other: conventional treatment

Device: Discogel

conventional treatment

Active Comparator group

Description:

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

Treatment:

Other: conventional treatment