Discogenic Back PainEGIDNCT02089139
Treatment of Discogenic Back Pain
A study testing Discogel and conventional treatment in people with Discogenic Back Pain, run by University Hospital, Limoges at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Discogenic Back Pain
- What is being tested?
- Discogel and conventional treatment
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Discogenic Back Pain
- Being tested
- Discogel, conventional treatment
- Keywords
- Back pain, Discogel
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiscogelDevice
DiscoGel is a sterile viscous solution containing ethyl alcohol, cellulose derivative product and tungsten (radio-opaque element)
conventional treatmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| DISCOGEL | Experimental | Percutaneous intradiscal injection of Discogel Receives: Device: Discogel; Other: conventional treatment |
| conventional treatment | Active comparator | 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 Receives: Other: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Mean pain intensity score on a Visual Analog Scale (VAS), six months after the procedure.
Measured: Six months after the procedure.
Secondary outcomes (3)
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 ;
Measured: 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 ;
Measured: 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
Measured: month, three months, six months and 1 year after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2018 (estimated)
- Study completionSep 2018 (estimated)
Why it stopped: The French medicines agency did not allow the continuation of the study (no patient enrolled in this study)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Discogenic Back PainStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Collaborators
- Gelscom SAS
- Responsible party
- Sponsor
- Investigators
- CAIRE François, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089139
- Sponsor's protocol ID
- I13009
- Acronym
- EGID
- Status last verified
- Sep 2015
- First submitted
- 13 Mar 2014
- Last updated
- 11 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intradiscal Injection of Gelified Ethanol for the Treatment of Discogenic Back Pain
- ClinicalTrials.gov ID
- NCT02089139
- Acronym / sponsor ID
- EGID / I13009
- Conditions
- Discogenic Back Pain
- Keywords
- Back pain, Discogel
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The French medicines agency did not allow the continuation of the study (no patient enrolled in this study)
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Collaborators
- Gelscom SAS
- Study start
- May 2014
- Primary completion
- May 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 17 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DISCOGEL | Experimental | Device: Discogel, Other: conventional treatmentPercutaneous intradiscal injection of Discogel |
| conventional treatment | Active comparator | Other: conventional treatmentconventional 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiscogelDiscoGel is a sterile viscous solution containing ethyl alcohol, cellulose derivative product and tungsten (radio-opaque element) | Device | DISCOGEL |
| conventional treatmentConventional 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 | DISCOGEL, conventional treatment |
Primary outcome
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.
3 secondary outcomes
Visual Analog Scale (VAS),
Time frame: one month, three months, six months and 1 year after the procedure
Oswestry Disability Index (ODI)
Time frame: one month, three months, six months and 1 year after the procedure
Euroqol score
Time frame: month, three months, six months and 1 year after the procedure
Results and safety
The study was stopped early (reason given: The French medicines agency did not allow the continuation of the study (no patient enrolled in this study)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CAIRE François, MD principal investigator
University Hospital, Limoges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discogel and conventional treatment in people with Discogenic Back Pain, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The French medicines agency did not allow the continuation of the study (no patient enrolled in this study)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Six months after the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2015.