Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-24 @ 4:50 PM
NCT ID:
NCT02313350
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* \- 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®
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02313350
Study Brief:
Protocol Section:
NCT02313350