A Phase 3 interventional study of Treatment in Neuropathic Pain and Chronic Postsurgical Pain, sponsored by University Hospital, Strasbourg, France. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by University Hospital, Strasbourg, France · Phase 3, Interventional, and Treatment
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).
1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.
This study's planned enrollment of 60 is above the median of 52 across 973 interventional studies indexed under Neuralgia.
Browse Neuralgia studies →University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.
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Exclusion criteria:
Surgery for disc herniation and intraoperative periradicular administration of PRF
Biological: Treatment
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.
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
Time frame: 6 months
Plan to share: Undecided
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University Hospital, Strasbourg, France