Treatment of Discogenic Back Pain (EGID)

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

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.

Study Overview

• Status: Terminated
• Conditions: Discogenic Back Pain
• Intervention / Treatment: Device: Discogel; Other: conventional treatment

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87042
    • Chu Limoges

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Collaborators: Gelscom SAS
• Investigators: Principal Investigator: CAIRE François, MD, University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: March 13, 2014
• First Submitted That Met QC Criteria: March 13, 2014
• First Posted (Estimate): March 17, 2014

Study Record Updates

• Last Update Posted (Estimate): September 11, 2015
• Last Update Submitted That Met QC Criteria: September 9, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Back pain; Discogel
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: I13009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No