search
Back to results

Treatment of Discogenic Back Pain (EGID)

Primary Purpose

Discogenic Back Pain

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Discogel
conventional treatment
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Discogenic Back Pain focused on measuring Back pain, Discogel

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • CHU Limoges

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DISCOGEL

conventional treatment

Arm Description

Percutaneous intradiscal injection of Discogel

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

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS)
Mean pain intensity score on a Visual Analog Scale (VAS), six months after the procedure.

Secondary Outcome Measures

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 ;
Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI) 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

Full Information

First Posted
March 13, 2014
Last Updated
September 9, 2015
Sponsor
University Hospital, Limoges
Collaborators
Gelscom SAS
search

1. Study Identification

Unique Protocol Identification Number
NCT02089139
Brief Title
Treatment of Discogenic Back Pain
Acronym
EGID
Official Title
Intradiscal Injection of Gelified Ethanol for the Treatment of Discogenic Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
The French medicines agency did not allow the continuation of the study (no patient enrolled in this study)
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges
Collaborators
Gelscom SAS

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Discogenic Back Pain
Keywords
Back pain, Discogel

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DISCOGEL
Arm Type
Experimental
Arm Description
Percutaneous intradiscal injection of Discogel
Arm Title
conventional treatment
Arm Type
Active Comparator
Arm Description
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
Device
Intervention Name(s)
Discogel
Intervention Description
DiscoGel is a sterile viscous solution containing ethyl alcohol, cellulose derivative product and tungsten (radio-opaque element)
Intervention Type
Other
Intervention Name(s)
conventional treatment
Intervention Description
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 Measure Information:
Title
Visual Analog Scale (VAS)
Description
Mean pain intensity score on a Visual Analog Scale (VAS), six months after the procedure.
Time Frame
Six months after the procedure.
Secondary Outcome Measure Information:
Title
Visual Analog Scale (VAS),
Description
Mean pain intensity score on Visual Analog Scale (VAS), one month, three months, six months and 1 year after the procedure ;
Time Frame
one month, three months, six months and 1 year after the procedure
Title
Oswestry Disability Index (ODI)
Description
Oswestry Disability Index (ODI) one month, three months, six months and 1 year after the procedure ;
Time Frame
one month, three months, six months and 1 year after the procedure
Title
Euroqol score
Description
Assessment of the quality of life with Euroqol score (EQ-5D) one month, three months, six months and 1 year after the procedure
Time Frame
month, three months, six months and 1 year after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CAIRE François, MD
Organizational Affiliation
University Hospital, Limoges
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France

12. IPD Sharing Statement

Learn more about this trial

Treatment of Discogenic Back Pain

We'll reach out to this number within 24 hrs