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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Active Comparator | Surgery for disc herniation and intraoperative periradicular administration of PRF |
|
| Control group | Active Comparator | Surgery for disc herniation alone (i.e. reference treatment). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment | Biological | Experimental product: product derived from autologous blood, obtained after centrifugation. Treatment modalities: intraoperative periradicular administration of autologous PRF. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erci SALVAT | Contact | +33 3 88 12 85 02 | eric.salvat@chru-strasbourg.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Les Hôpitaux Universitaires | Recruiting | Strasbourg | Bas-Rhin | 67091 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37337269 | Derived | 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. |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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