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 (NeuroPRF)

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ClinicalTrials.gov Identifier: NCT05196503

Recruitment Status : Recruiting

First Posted : January 19, 2022

Last Update Posted : March 11, 2022

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Sponsor:

Information provided by (Responsible Party):

University Hospital, Strasbourg, France

Study Description

Brief Summary:

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. Certain well-tolerated techniques, such as the administration of plasma enriched with platelets and fibrin (PRF), are increasingly used in regenerative medicine for their anti-inflammatory and analgesic properties. Thus, a periradicular intraoperative application of PRF may have an analgesic effect on the intensity of residual postsurgical neuropathic pain after disc herniation surgery.

Condition or disease	Intervention/treatment	Phase
Neuropathic Pain Chronic Postsurgical Pain	Biological: Treatment	Phase 3

Detailed Description:

A superiority study, phase III, prospective, single-center, randomized in parallel groups and conducted in a single-blind manner, with evaluation by a blind outcome assessor. Patients will be randomized to one of two treatment groups: Experimental group (surgery and periradicular administration of PRF) or Control group (reference treatment, surgery alone).

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Efficacy of Platelet Rich Fibrin in the Prevention of Residual Neuropathic Pain Following Disc Herniation Surgery
Actual Study Start Date :	February 23, 2022
Actual Primary Completion Date :	February 23, 2022
Estimated Study Completion Date :	January 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia Herniated Disk

Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Experimental group Surgery for disc herniation and intraoperative periradicular administration of PRF	Biological: Treatment Experimental product: product derived from autologous blood, obtained after centrifugation. Treatment modalities: intraoperative periradicular administration of autologous PRF.
Active Comparator: Control group Surgery for disc herniation alone (i.e. reference treatment).	Biological: Treatment Experimental product: product derived from autologous blood, obtained after centrifugation. Treatment modalities: intraoperative periradicular administration of autologous PRF.

Outcome Measures

Primary Outcome Measures :

Assess the effectiveness of periricular intraoperative application of Platelet- and Fibrin-enriched plasma (PRF) on the intensity of residual neuropathic pain postoperatively with primary herniated disc surgery. [ Time Frame: 6 months ]
Average intensity, over 24 hours, of a sequellar radicular neuropathic painy an EVA and affirmed by a DN4 score greater than or equal to 4

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion 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.

Exclusion criteria:

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.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05196503

Contacts

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Contact: Erci SALVAT	+33 3 88 12 85 02	eric.salvat@chru-strasbourg.fr

Locations

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France
Les Hôpitaux Universitaires	Recruiting
Strasbourg, Bas-Rhin, France, 67091
Contact: Eric SALVAT +33 3 88 12 85 02 eric.salvat@chru-strasbourg.fr
Sub-Investigator: Daniel TIMBOLSCHI IONUT
Sub-Investigator: Lauriane JOGANAH
Sub-Investigator: André MULLER
Sub-Investigator: Yohann BOHREN
Sub-Investigator: François PROUST
Sub-Investigator: Hugo Andres COCA

Sponsors and Collaborators

University Hospital, Strasbourg, France

More Information

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Responsible Party:	University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:	NCT05196503
Other Study ID Numbers:	8363
First Posted:	January 19, 2022 Key Record Dates
Last Update Posted:	March 11, 2022
Last Verified:	February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by University Hospital, Strasbourg, France:


Neuropathic pain Chronic postsurgical pain prevention Intraoperative platelet rich fibrin Disc herniation surgery

Additional relevant MeSH terms:

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Intervertebral Disc Displacement Neuralgia Hernia Pain, Postoperative Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Pain	Neurologic Manifestations Pathological Conditions, Anatomical Spinal Diseases Bone Diseases Musculoskeletal Diseases Postoperative Complications Pathologic Processes

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