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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Platelet Rich Fibrin in the Prevention of Residual Neuropathic Pain Following Disc Herniation Surgery
- ClinicalTrials.gov ID
- NCT05196503
- Acronym / sponsor ID
- NeuroPRF / 8363
- Conditions
- Neuropathic Pain, Chronic Postsurgical Pain
- Keywords
- Neuropathic pain, Chronic postsurgical pain prevention, Intraoperative platelet rich fibrin, Disc herniation surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 23 Feb 2022 (actual)
- Study completion
- Jan 2028 (estimated)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Active comparator | Biological: TreatmentSurgery for disc herniation and intraoperative periradicular administration of PRF |
| Control group | Active comparator | Biological: TreatmentSurgery for disc herniation alone (i.e. reference treatment). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TreatmentExperimental product: product derived from autologous blood, obtained after centrifugation. Treatment modalities: intraoperative periradicular administration of autologous PRF. | Biological | Control group, Experimental group |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Derived from this study: PubMed 37337269Todeschi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erci SALVAT (+33 3 88 12 85 02, eric.salvat@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05196503, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.