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Treatment of Discogenic Back Pain (EGID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02089139
Recruitment Status : Terminated (The French medicines agency did not allow the continuation of the study (no patient enrolled in this study))
First Posted : March 17, 2014
Last Update Posted : September 11, 2015
Sponsor:
Collaborator:
Gelscom SAS
Information provided by (Responsible Party):
University Hospital, Limoges

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.


Condition or disease Intervention/treatment Phase
Discogenic Back Pain Device: Discogel Other: conventional treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intradiscal Injection of Gelified Ethanol for the Treatment of Discogenic Back Pain
Study Start Date : May 2014
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: DISCOGEL
Percutaneous intradiscal injection of Discogel
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

Active Comparator: 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
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




Primary Outcome Measures :
  1. Visual Analog Scale (VAS) [ Time Frame: Six months after the procedure. ]
    Mean pain intensity score on a Visual Analog Scale (VAS), six months after the procedure.


Secondary Outcome Measures :
  1. Visual Analog Scale (VAS), [ Time Frame: 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 ;

  2. Oswestry Disability Index (ODI) [ Time Frame: 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 ;

  3. Euroqol score [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089139


Locations
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France
CHU Limoges
Limoges, France, 87042
Sponsors and Collaborators
University Hospital, Limoges
Gelscom SAS
Investigators
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Principal Investigator: CAIRE François, MD University Hospital, Limoges

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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT02089139     History of Changes
Other Study ID Numbers: I13009
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: September 11, 2015
Last Verified: September 2015
Keywords provided by University Hospital, Limoges:
Back pain
Discogel
Additional relevant MeSH terms:
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Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms