Treatment of Discogenic Back Pain

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02089139

Acronym

EGID

Enrollment

Registered

2014-03-17

Start date

2014-05-31

Completion date

2018-09-30

Last updated

2015-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Discogenic Back Pain

Keywords

Back pain, Discogel

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.

Interventions

DEVICEDiscogel

DiscoGel is a sterile viscous solution containing ethyl alcohol, cellulose derivative product and tungsten (radio-opaque element)

OTHERconventional 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Visual Analog Scale (VAS)	Six months after the procedure.	Mean pain intensity score on a Visual Analog Scale (VAS), six months after the procedure.

Secondary

Measure	Time frame	Description
Visual Analog Scale (VAS),	one month, three months, six months and 1 year after the procedure	Mean pain intensity score on Visual Analog Scale (VAS), one month, three months, six months and 1 year after the procedure ;
Oswestry Disability Index (ODI)	one month, three months, six months and 1 year after the procedure	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	Assessment of the quality of life with Euroqol score (EQ-5D) one month, three months, six months and 1 year after the procedure

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026