BridgeMD
Tests treatment safety and results for Neuropathic Pain
Official title Efficacy of an Intraoperative Periradicular Application of Platelet Rich Fibrin (PRF) on the Intensity of Residual Post-surgical Neuropathic Pain After a Surgery for Disc Herniation
ClinicalTrials.gov ID: NCT05196503
What this study is testing
What is Treatment?
Treatment is an investigational medicine, being studied as a potential treatment for neuropathic pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The prevalence of post-surgical lumbar neuropathic radiculopathy is approximately 30%. Poor response to the treatments recommended for neuropathic pain, namely antidepressants and/or gabapentinoids, requires the development of new techniques to prevent this chronic pain.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient, male or female, \>18 years old at the time of signing informed consent;
- Patient for whom a diagnosis of radiculopathy on lumbar disc herniation has been made, and for whom surgery has been scheduled in the Neurosurgery...
- Patient affiliated to a social security health insurance scheme;
- Patient able to understand the objectives and risks of research and to give informed, dated and signed consent;
- Patient having been informed of the results of the prior medical examination;
You likely can't join if
- Patient with a history of lumbar spinal surgery (multiple herniated discs, herniated disc other than lumbar);
- Patient with HIV, active cancer, HBV, HCV (verified by interview);
- Patient on long-term systemic corticosteroid therapy;
- Patient with an ASA score \> 3 during the consultation with the anesthesiologist;
- Inability to give the patient informed information (patient in an emergency or life-threatening situation, difficulties in understanding);
- Patient in exclusion period (determined by a previous or ongoing study);
See the full eligibility criteria
- Patient, male or female, \>18 years old at the time of signing informed consent;
- Patient for whom a diagnosis of radiculopathy on lumbar disc herniation has been made, and for whom surgery has been scheduled in the Neurosurgery department;
- Patient affiliated to a social security health insurance scheme;
- Patient able to understand the objectives and risks of research and to give informed, dated and signed consent;
- Patient having been informed of the results of the prior medical examination;
- Women of childbearing age provided that a negative blood pregnancy test is recorded at the inclusion visit and effective contraception used throughout the study.
- Patient with a history of lumbar spinal surgery (multiple herniated discs, herniated disc other than lumbar);
- Patient with HIV, active cancer, HBV, HCV (verified by interview);
- Patient on long-term systemic corticosteroid therapy;
- Patient with an ASA score \> 3 during the consultation with the anesthesiologist;
- Inability to give the patient informed information (patient in an emergency or life-threatening situation, difficulties in understanding);
- Patient in exclusion period (determined by a previous or ongoing study);
- Subject under safeguard of justice;
- Subject under curatorship;
- Pregnancy;
- Breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Strasbourg, Bas-Rhin, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Strasbourg, Bas-Rhin, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.