Clinical Trial: Intradiscal Discogel® in Resistant Sciatica
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Non-inferiority Trial of Intradiscal Discogel® Versus Surgery in Sciatica Resistant to Conservative Treatment
Brief 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.
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 Summary:
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:
Current 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- AUC of back pain score on a visual-analogue scale between 0 and 52 weeks [ Time Frame: 4, 8, 16, 24 and 52 weeks ]Pain and questionnaires will be fulfilled by the patient alone and the assessor will be blinded.
- 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 ]in Discogel® group only
- Number of surgical interventions avoided in the Discogel® arm [ Time Frame: 52 weeks ]in Discogel® group Only
- 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 ]
Original Secondary Outcome: Same as current
Information By: Assistance Publique - Hôpitaux de Paris
Dates:
Date Received: December 5, 2014
Date Started: September 2017
Date Completion: January 2018
Last Updated: January 3, 2017
Last Verified: December 2016
