Treatment of Discogenic Back Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2018-09-30

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.

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Detailed Description

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Conditions

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Discogenic Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DISCOGEL

Percutaneous intradiscal injection of Discogel

Group Type EXPERIMENTAL

Discogel

Intervention Type DEVICE

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

conventional treatment

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

conventional treatment

Intervention Type OTHER

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

Interventions

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Discogel

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

Intervention Type DEVICE

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

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No