NCT05196503

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2022

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

February 23, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2022

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

Same day

First QC Date

August 26, 2021

Last Update Submit

April 14, 2023

Conditions

Neuropathic PainChronic Postsurgical Pain

Keywords

Neuropathic painChronic postsurgical pain preventionIntraoperative platelet rich fibrinDisc herniation surgery

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    6 months

Study Arms (2)

Experimental group

ACTIVE COMPARATOR

Surgery for disc herniation and intraoperative periradicular administration of PRF

Biological: Treatment

Control group

ACTIVE COMPARATOR

Surgery for disc herniation alone (i.e. reference treatment).

Biological: Treatment

Interventions

TreatmentBIOLOGICAL

Experimental product: product derived from autologous blood, obtained after centrifugation. Treatment modalities: intraoperative periradicular administration of autologous PRF.

Control groupExperimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 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;

You may not qualify 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);
  • Subject under safeguard of justice;
  • Subject under curatorship;
  • Pregnancy;
  • Breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Les Hôpitaux Universitaires

Strasbourg, Bas-Rhin, 67091, France

RECRUITING

Related Publications (1)

  • Todeschi J, Dannhoff G, Coca AH, Timbolschi DI, Proust F, Lefebvre F, Lelievre V, Poisbeau P, Vallat L, Salvat E, Bohren Y. Effect of an intraoperative periradicular application of platelet-rich fibrin (PRF) on residual post-surgical neuropathic pain after disc herniation surgery: study protocol for NeuroPRF, a randomized controlled trial. Trials. 2023 Jun 19;24(1):418. doi: 10.1186/s13063-023-07420-y.

    PMID: 37337269DERIVED

MeSH Terms

Conditions

NeuralgiaPain, Postoperative

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Central Study Contacts

Erci SALVAT

CONTACT

+33 3 88 12 85 02eric.salvat@chru-strasbourg.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2021

First Posted

January 19, 2022

Study Start

February 23, 2022

Primary Completion

February 23, 2022

Study Completion

January 1, 2025

Last Updated

April 18, 2023

Record last verified: 2023-04

Locations

FR(1)