Treatment of Discogenic Back Pain

Study Overview
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Brief Summary
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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.

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

Conditions
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Discogenic Back Pain

Intervention / Treatment
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* Device: Discogel
* Other: conventional treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DISCOGEL<br>Percutaneous intradiscal injection of Discogel | Device: Discogel<br>* DiscoGel is a sterile viscous solution containing ethyl alcohol, cellulose derivative product and tungsten (radio-opaque element)<br>Other: conventional treatment<br>* 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<br>|
| Active Comparator: conventional treatment<br>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 | Other: conventional treatment<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Back pain, Discogel