Neuropathic PainPhase 3NeuroPRFNCT05196503
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
A Phase 3 study testing Treatment in people with Neuropathic Pain and Chronic Postsurgical Pain, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain, Chronic Postsurgical Pain
- What is being tested?
- Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 23 Feb 2022to Jan 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- Subject under safeguard of justice;
- Subject under curatorship;
- Pregnancy;
- Breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Les Hôpitaux Universitaires
Strasbourg, Bas-Rhin, 67091
Eric SALVAT, +33 3 88 12 85 02, eric.salvat@chru-strasbourg.fr
Daniel TIMBOLSCHI IONUT
About this study
Official title: Efficacy of Platelet Rich Fibrin in the Prevention of Residual Neuropathic Pain Following Disc Herniation Surgery
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.
Read the 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).
- Conditions
- Neuropathic Pain, Chronic Postsurgical Pain
- Being tested
- Treatment
- Keywords
- Neuropathic pain, Chronic postsurgical pain prevention, Intraoperative platelet rich fibrin, Disc herniation surgery
- Medical subject headings
- Neuralgia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentBiological
Experimental product: product derived from autologous blood, obtained after centrifugation.
Treatment modalities: intraoperative periradicular administration of autologous PRF.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Active comparator | Surgery for disc herniation and intraoperative periradicular administration of PRF Receives: Biological: Treatment |
| Control group | Active comparator | Surgery for disc herniation alone (i.e. reference treatment). Receives: Biological: Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start23 Feb 2022
- Primary completion23 Feb 2022
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196503
- Sponsor's protocol ID
- 8363
- Acronym
- NeuroPRF
- Status last verified
- Jun 2026
- First submitted
- 26 Aug 2021
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37337269