Herniated DiscEDISNCT02313350
Intradiscal Discogel® in Resistant Sciatica
A study testing Chemonucleolysis with Discogel and open discectomy in people with Herniated Disc and Sciatica, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Sciatica due to herniated disc is a major cause of disability in young adults. Surgery is the gold-standard and the only controlled treatment in case of failure of conservative treatment. Percutaneous chemonucleolysis with Discogel® may be a valuable alternative to surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herniated Disc, Sciatica, Persistent Pain, Leg
- What is being tested?
- Chemonucleolysis with Discogel and open discectomy
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2017to Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18
- L5 or S1 sciatica due to a herniated disc demonstrated at a MRI performed at a maximum of 8 weeks prior to inclusion
- Leg pain intensity superior to 40mm on a visual-analogue scale despite pain medication (patient with pain level of less than 40 mm and under morphinic treatment, morphine should be first replaced by level 2 medication).
- Leg pain predominant over low back pain
- Duration of sciatica of the current symptomatic episode: from 6 weeks to 40 weeks
- Leg pain resistant to conservative treatment including at least two epidural steroid injections and at least one steroid injection under fluoroscopic guidance, during the current symptomatic episode
- With or without sensitive deficit
Who cannot join
- - Motricity index < 3/5
- Cauda equinal syndrome
- Sequestered disc herniation visible at MRI
- Calcified/ossified disc herniation visible at MRI
- Intervertebral disc height narrowing > 60%
- Previous back surgery or percutaneous disc treatment at the same intervertebral level
- Psychiatric status precluding patient evaluation
- Pregnancy Any known or documented allergy to one of the components of the Discogel®
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-inferiority Trial of Intradiscal Discogel® Versus Surgery in Sciatica Resistant to Conservative Treatment
Sciatica due to herniated disc is a major cause of disability in young adults. Surgery is the gold-standard and the only controlled treatment in case of failure of conservative treatment.
Percutaneous chemonucleolysis with Discogel® may be a valuable alternative to surgery.
Read more
In addition, Discogel® chemonucleolysis appears as a relatively innocuous technique which may avoid 2% complications after disc surgery and 5% repeated surgery (according to recent trials).
This will be the first randomized trial comparing Discogel® chemonucleolysis versus surgery in patients with sciatica due to lumbar disc herniation and unresponsive to conservative medical treatments (including epidural steroid injections) Our expectation is that Discogel® chemonucleolysis will avoid surgery in 80% of the patients.
Read the detailed description
Since chymopapain was taken off the market in 2002, no percutaneous treatment has been proven to be a valuable alternative to surgical discectomy in herniated disk-related sciatica. Intradiscal injection of alcohol was a possibly efficient technique but was not used due to its rapid dissipation and nerve toxicity. The gel, by stabilizing the alcohol into the disc, now makes it effective locally and cancels its nerve toxicity. As a preliminary evaluation, we conducted an open trial with strict methodological criteria to test the efficiency of an intradiscal injection using a new product based on jellified ethanol, Discogel®, in the treatment of nerve root pain due to compression by herniated disk. A 30% improvement in pain VAS was obtained in two thirds of the patients. No complication was encountered. These results prompted us to further investigate the effectiveness of Discogel® chemonucleolysis using a randomized design comparing it to surgery which remains the gold-standard treatment for disk-related sciatica resistant to conservative treatment. Our hypothesis is that chemonucleolysis using Discogel® has suitable efficacy and safety profile for large application in the treatment of persistent herniated disc related sciatica and that it is consequently able to reduce the need of surgery, namely open discectomy, in this indication. New minimally invasive approach of herniated disc-related sciatica is crucial, due to high prevalence and medico-economic impact of the disease. Awaited advances are enrichment of management strategies for herniated disc-related sciatica, earlier recovery of patients unresponsive to first line conservative treatment, reduction of the costs and serious adverse events related with surgery and finally reduction of the costs associated with induced sciatica disability.
Study design:
- Open randomized non-inferiority clinical trial
- Discogel® vs surgery, to be organized within four next weeks after randomization
- Eligible patients who decline participation to the trial will be followed in an observational cohort at the same time-frame as the randomized cohort
- Measurement of compliance with the assigned treatment
- Patients randomized who will delay or decline the assigned treatment will not be excluded from the trial
- Visits at 4, 8, 16, 24 and 52 weeks (evaluation of the main and secondary outcomes)
- Result analysis will be conducted in Intention to treat
- Surgery will be allowed in the Discogel® arm starting at the 16 W visit or before in case of intractable pain or complication.
Study procedures:
Enrollment of patients will be done from the consultations of Rheumatology, Radiology, Surgery and Physical and Rehabilitation Medicine Departments of each study center. Indeed, the inclusion visit will not be done by the physician who will perform the chemonucleolysis, or the surgeon in charge of the patient. After randomization, chemonucleolysis or surgery will be scheduled within the four next weeks. Patients undergoing chemonucleolysis will be hospitalized in day hospital of the Rheumatology / Surgery department of each study center. The procedure of chemonucleolysis will be performed in the corresponding Radiology department or in the usual department. Open discectomy will be performed during a conventional hospitalization in the Surgery department of each study center. Duration of the hospital stay will depend on patient's recovery after surgery. A duration of about one week is expected.
The follow-up of patients will be 52 weeks (5 time points). At each time point, main and secondary outcomes will be evaluated. Questionnaires will be filled out by the patient, before the consultation visit. An independent person (nurse, secretary, clinical research technician..) will be available to help the patient to fill his self questionnaire and check for the accuracy of the patient answers. It is important to note no physician involved in the protocol will participate to the patient evaluation. The physician assessor will be blinded for the result of the questionnaire.
- Conditions
- Herniated Disc, Sciatica, Persistent Pain, Leg
- Being tested
- Chemonucleolysis with Discogel, open discectomy
- Keywords
- Sciatica,, herniated disc,, chemonucleolysis.
- Medical subject headings
- Intervertebral Disc Displacement, Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemonucleolysis with DiscogelDevice
Discogel® is provided in a kit containing a 2 ml solution for injection with two disposable 1ml syringes, each for single use which is stored at room temperature. Discogel® chemonucleolysis for herniated disc-related sciatica is performed under local anesthesia .
open discectomyProcedure or surgery
The comparator is open surgical discectomy. The procedure will be performed under general anesthesia. It will consist in removing the disc herniation after exposition and examination of the nerve root.
| Study group | Role | What they receive |
|---|---|---|
| Chemonucleolysis with Discogel | Experimental | Discogel® is a class III medical device (CE0459 mark on 28/09/2007) constituted by a radiopaque jellified ethanol. Discogel® is provided in a kit containing a 2 ml solution for injection with two disposable 1ml syringes. Discogel® chemonucleolysis for herniated disc-related sciatica is performed under local anesthesia. A volume of 0.9 ml of Discogel® is finally slowly injected during 10 to 15 minutes Receives: Device: Chemonucleolysis with Discogel |
| Open discectomy | Active comparator | surgery : The comparator is open surgical discectomy. The procedure will be performed under general anesthesia. It will consist in removing the disc herniation after exposition and examination of the nerve root Receives: Procedure: open discectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve (AUC) of the leg pain score on a 100-mm visual analogue scale
The primary endpoint is the AUC of the leg pain score on a 100-mm visual-analogue scale, assessed by the patient in a self questionnaire at 4, 8, 16, 24 and 52 weeks, calculated by the trapezoidal method.The assessor will be blinded for the result of questionnaires
Measured: 4, 8, 16, 24 and 52 weeks
Secondary outcomes (12)
AUC of back pain score on a visual-analogue scale between 0 and 52 weeks
Pain and questionnaires will be fulfilled by the patient alone and the assessor will be blinded.
Measured: 4, 8, 16, 24 and 52 weeks
AUC of global pain score on a visual-analogue scale between 0 and 52 weeks
Measured: 4, 8, 16, 24 and 52 weeks
AUC of Quality of life (SF36) between 0 and 52 weeks
Measured: 4, 8, 16, 24 and 52 weeks
Functional disability using the Roland disability questionnaire
Measured: at 4, 8, 16, 24, 52 weeks
Assessment of sciatica using the Modified Roland Morris disability scale
Measured: at 4, 8, 16, 24, 52 weeks
Medication and other treatment consumption during the one-year Follow-up (FU)
Measured: at 4, 8, 16, 24, 52 weeks
Cost-effectiveness in both arms (costs, utilities based on -EQ5D™ scores, cost utility analysis)
Measured: 52 weeks
Percentage of surgery in the Discogel® chemonucleolysis arm
in Discogel® group only
Measured: 52 weeks
Number of surgical interventions avoided in the Discogel® arm
in Discogel® group Only
Measured: 52 weeks
Number of assigned treatments finally performed (adherence to assigned treatment in both arms)
Measured: 52 weeks
Adverse events
Measured: 52 weeks
Number of secondary surgical interventions after Discogel® or after first open discectomy
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startSep 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionJan 2018 (estimated)
Why it stopped: faisability
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herniated DiscStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Gelscom SAS
- Responsible party
- Sponsor
- Investigators
- Johann Beaudreuil, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313350
- Sponsor's protocol ID
- : P130913
- Acronym
- EDIS
- Status last verified
- Jun 2021
- First submitted
- 5 Dec 2014
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Trial of Intradiscal Discogel® Versus Surgery in Sciatica Resistant to Conservative Treatment
- ClinicalTrials.gov ID
- NCT02313350
- Acronym / sponsor ID
- EDIS / : P130913
- Conditions
- Herniated Disc, Sciatica, Persistent Pain, Leg
- Keywords
- Sciatica,, herniated disc,, chemonucleolysis.
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: faisability
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Gelscom SAS
- Study start
- Sep 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 10 Dec 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.
Sciatica due to herniated disc is a major cause of disability in young adults. Surgery is the gold-standard and the only controlled treatment in case of failure of conservative treatment.
Percutaneous chemonucleolysis with Discogel® may be a valuable alternative to surgery.
In addition, Discogel® chemonucleolysis appears as a relatively innocuous technique which may avoid 2% complications after disc surgery and 5% repeated surgery (according to recent trials).
This will be the first randomized trial comparing Discogel® chemonucleolysis versus surgery in patients with sciatica due to lumbar disc herniation and unresponsive to conservative medical treatments (including epidural steroid injections) Our expectation is that Discogel® chemonucleolysis will avoid surgery in 80% of the patients.
Detailed description
Since chymopapain was taken off the market in 2002, no percutaneous treatment has been proven to be a valuable alternative to surgical discectomy in herniated disk-related sciatica. Intradiscal injection of alcohol was a possibly efficient technique but was not used due to its rapid dissipation and nerve toxicity. The gel, by stabilizing the alcohol into the disc, now makes it effective locally and cancels its nerve toxicity. As a preliminary evaluation, we conducted an open trial with strict methodological criteria to test the efficiency of an intradiscal injection using a new product based on jellified ethanol, Discogel®, in the treatment of nerve root pain due to compression by herniated disk. A 30% improvement in pain VAS was obtained in two thirds of the patients. No complication was encountered. These results prompted us to further investigate the effectiveness of Discogel® chemonucleolysis using a randomized design comparing it to surgery which remains the gold-standard treatment for disk-related sciatica resistant to conservative treatment. Our hypothesis is that chemonucleolysis using Discogel® has suitable efficacy and safety profile for large application in the treatment of persistent herniated disc related sciatica and that it is consequently able to reduce the need of surgery, namely open discectomy, in this indication. New minimally invasive approach of herniated disc-related sciatica is crucial, due to high prevalence and medico-economic impact of the disease. Awaited advances are enrichment of management strategies for herniated disc-related sciatica, earlier recovery of patients unresponsive to first line conservative treatment, reduction of the costs and serious adverse events related with surgery and finally reduction of the costs associated with induced sciatica disability.
Study design:
- Open randomized non-inferiority clinical trial
- Discogel® vs surgery, to be organized within four next weeks after randomization
- Eligible patients who decline participation to the trial will be followed in an observational cohort at the same time-frame as the randomized cohort
- Measurement of compliance with the assigned treatment
- Patients randomized who will delay or decline the assigned treatment will not be excluded from the trial
- Visits at 4, 8, 16, 24 and 52 weeks (evaluation of the main and secondary outcomes)
- Result analysis will be conducted in Intention to treat
- Surgery will be allowed in the Discogel® arm starting at the 16 W visit or before in case of intractable pain or complication.
Study procedures:
Enrollment of patients will be done from the consultations of Rheumatology, Radiology, Surgery and Physical and Rehabilitation Medicine Departments of each study center. Indeed, the inclusion visit will not be done by the physician who will perform the chemonucleolysis, or the surgeon in charge of the patient. After randomization, chemonucleolysis or surgery will be scheduled within the four next weeks. Patients undergoing chemonucleolysis will be hospitalized in day hospital of the Rheumatology / Surgery department of each study center. The procedure of chemonucleolysis will be performed in the corresponding Radiology department or in the usual department. Open discectomy will be performed during a conventional hospitalization in the Surgery department of each study center. Duration of the hospital stay will depend on patient's recovery after surgery. A duration of about one week is expected.
The follow-up of patients will be 52 weeks (5 time points). At each time point, main and secondary outcomes will be evaluated. Questionnaires will be filled out by the patient, before the consultation visit. An independent person (nurse, secretary, clinical research technician..) will be available to help the patient to fill his self questionnaire and check for the accuracy of the patient answers. It is important to note no physician involved in the protocol will participate to the patient evaluation. The physician assessor will be blinded for the result of the questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemonucleolysis with Discogel | Experimental | Device: Chemonucleolysis with DiscogelDiscogel® is a class III medical device (CE0459 mark on 28/09/2007) constituted by a radiopaque jellified ethanol. Discogel® is provided in a kit containing a 2 ml solution for injection with two disposable 1ml syringes. Discogel® chemonucleolysis for herniated disc-related sciatica is performed under local anesthesia. A volume of 0.9 ml of Discogel® is finally slowly injected during 10 to 15 minutes |
| Open discectomy | Active comparator | Procedure: open discectomysurgery : The comparator is open surgical discectomy. The procedure will be performed under general anesthesia. It will consist in removing the disc herniation after exposition and examination of the nerve root |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18
- L5 or S1 sciatica due to a herniated disc demonstrated at a MRI performed at a maximum of 8 weeks prior to inclusion
- Leg pain intensity superior to 40mm on a visual-analogue scale despite pain medication (patient with pain level of less than 40 mm and under morphinic treatment, morphine should be first replaced by level 2 medication).
- Leg pain predominant over low back pain
- Duration of sciatica of the current symptomatic episode: from 6 weeks to 40 weeks
Key exclusion criteria (8 listed)
- - Motricity index < 3/5
- Cauda equinal syndrome
- Sequestered disc herniation visible at MRI
- Calcified/ossified disc herniation visible at MRI
- Intervertebral disc height narrowing > 60%
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 |
|---|---|---|
| Chemonucleolysis with DiscogelDiscogel® is provided in a kit containing a 2 ml solution for injection with two disposable 1ml syringes, each for single use which is stored at room temperature. Discogel® chemonucleolysis for herniated disc-related sciatica is performed under local anesthesia . | Device | Chemonucleolysis with Discogel |
| open discectomyThe comparator is open surgical discectomy. The procedure will be performed under general anesthesia. It will consist in removing the disc herniation after exposition and examination of the nerve root. | Procedure or surgery | Open discectomy |
Primary outcome
Area under curve (AUC) of the leg pain score on a 100-mm visual analogue scale
Time frame: 4, 8, 16, 24 and 52 weeks
The primary endpoint is the AUC of the leg pain score on a 100-mm visual-analogue scale, assessed by the patient in a self questionnaire at 4, 8, 16, 24 and 52 weeks, calculated by the trapezoidal method.The assessor will be blinded for the result of questionnaires
12 secondary outcomes
AUC of back pain score on a visual-analogue scale between 0 and 52 weeks
Time frame: 4, 8, 16, 24 and 52 weeks
AUC of global pain score on a visual-analogue scale between 0 and 52 weeks
Time frame: 4, 8, 16, 24 and 52 weeks
AUC of Quality of life (SF36) between 0 and 52 weeks
Time frame: 4, 8, 16, 24 and 52 weeks
Functional disability using the Roland disability questionnaire
Time frame: at 4, 8, 16, 24, 52 weeks
Assessment of sciatica using the Modified Roland Morris disability scale
Time frame: at 4, 8, 16, 24, 52 weeks
Medication and other treatment consumption during the one-year Follow-up (FU)
Time frame: at 4, 8, 16, 24, 52 weeks
Cost-effectiveness in both arms (costs, utilities based on -EQ5D™ scores, cost utility analysis)
Time frame: 52 weeks
Percentage of surgery in the Discogel® chemonucleolysis arm
Time frame: 52 weeks
Number of surgical interventions avoided in the Discogel® arm
Time frame: 52 weeks
Number of assigned treatments finally performed (adherence to assigned treatment in both arms)
Time frame: 52 weeks
Adverse events
Time frame: 52 weeks
Number of secondary surgical interventions after Discogel® or after first open discectomy
Time frame: 52 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
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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.
Johann Beaudreuil principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chemonucleolysis with Discogel and open discectomy in people with Herniated Disc and Sciatica, run by Assistance Publique - Hôpitaux de Paris 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 7 inclusion and 8 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: withdrawn, as of the sponsor's last update on 18 Jun 2021. 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 withdrawn before enrolling participants, so there are no results.
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?
Area under curve (AUC) of the leg pain score on a 100-mm visual analogue scale (time frame: 4, 8, 16, 24 and 52 weeks). 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 18 Jun 2021.