Assesment of Epidural Platelet-Rich Plasma (PRP) Injection During Uniportal Endoscopic Lumbar Disc Herniation Excision on Residual Neuropathies (HERDISPLA)
18. august 2026 oppdatert av: GCS Ramsay Santé pour l'Enseignement et la Recherche
Assesment of Epidural Platelet-Rich Plasma (PRP) Injection During Uniportal Endoscopic Lumbar Disc Herniation Excision on Residual Neuropathies: An Exploratory Study.
The aim of this study is to assess neuropathic pain in the lower limb at 6 months post-operation in patients who have undergone surgery for a lumbar disc herniation using single-port endoscopic discectomy combined with an epidural PRP injection.
This study is based on the hypothesis that intraoperative epidural administration of PRP during discectomy may improve healing, reduce nerve inflammation and potentially minimise post-operative pain and complications.
Participants will perform an epidural PRP injection and questionnaires as part of this research.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
50
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Lyon, Frankrike, 69008
- Hôpital privé Jean Mermoz
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Ta kontakt med:
- Dr Henri d'Astorg
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Patients, male or female, aged ≥ 18 and ≤ 55
- Patients with a diagnosis of a single-level lumbar disc herniation confirmed by MRI
- Patients in whom conservative treatment has failed for at least 6 weeks
- Patients for whom monoportal endoscopic lumbar disc herniation excision is indicated
- Patients with lower-limb radicular pain of an intensity ≥ 3/10 on the Numerical Pain Scale
- Patients affiliated with or covered by a social security scheme
- French-speaking patients who have signed an informed consent form
Exclusion Criteria:
- Patients with a history of lumbar spine surgery or epidural injection
- Patients with progressive neurological deficits or cauda equina syndrome
- Patients with coagulopathy or systemic hematological disorders
- Patients with an active infection or autoimmune disease
- Patients with multilevel disc herniation or concomitant cervical spine pathology
- Patients with scoliosis > 40°.
- Patients already enrolled in another clinical study
- Protected patients: adults under guardianship, curatorship, or other legal protection measures; patients deprived of liberty by judicial or administrative decision
- Patients hospitalized without consent
- Patients receiving psychiatric care
- Patients unable to provide informed consent.
- Pregnant or breastfeeding women, including parturient women
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Epidural PRP injection
PRP collection and injection at the end of surgery (herniated disc removal)
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PRP is obtained from the patient's own blood, prepared, and subsequently reinjected into the patient at the end of uniportal endoscopic lumbar disc herniation removal.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Presence of neuropathic pain
Tidsramme: At 6 months follow-up
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Neuropathic pain will be assessed with DN-4 questionnaire.
If the score is 4 or higher, the test is considered positive (0 is the minimum value, 10 the maximum value (the worst pain)).
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At 6 months follow-up
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Presence of neuropathic pain
Tidsramme: At 2 and 6 weeks follow-up and 3, 6 and 12 months follow-up
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Neuropathic pain will be assessed with DN-4 questionnaire.
If the score is 4 or higher, the test is considered positive (0 is the minimum value, 10 the maximum value (the worst pain)).
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At 2 and 6 weeks follow-up and 3, 6 and 12 months follow-up
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Progression of neuropathic pain
Tidsramme: At baseline, 2 and 6 weeks follow-up and 3, 6 and 12 months follow-up
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The progression of neuropathic pain will be assessed with DN-4 questionnaire, at all follow-up visit compared to baseline.
0 is the minimum value, 10 the maximum value (the worst pain).
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At baseline, 2 and 6 weeks follow-up and 3, 6 and 12 months follow-up
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Progression of leg radicular pain
Tidsramme: At baseline, 2 and 6 weeks follow-up and 3, 6 and 12 months follow-up.
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Progression of leg radicular pain will be assessed with a numerical rating scale (0 is the minimum value (no pain), 10 is the maximum value (the worst pain))
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At baseline, 2 and 6 weeks follow-up and 3, 6 and 12 months follow-up.
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Progression of back pain
Tidsramme: At baseline, 2 and 6 weeks follow-up and 3, 6 and 12 months follow-up
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Progression of back pain will be assessed with a numerical rating scale (0 is the minimum value (no pain), 10 is the maximum value (the worst pain))
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At baseline, 2 and 6 weeks follow-up and 3, 6 and 12 months follow-up
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Progression of disability
Tidsramme: At baseline, 2 and 6 weeks follow-up, and 3, 6 and 12 months follow-up.
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Progression of disability will be assessed by ODI questionnaire.
Minimum value is 0, maximum value is 50 (maximum disability)
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At baseline, 2 and 6 weeks follow-up, and 3, 6 and 12 months follow-up.
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Therapeutic failure
Tidsramme: At 2 and 6 weeks follow-up and 3, 6 and 12 months follow-up
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Therapeutic failure will be assessed by presence or absence of additional surgery for persistent or worsening pain.
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At 2 and 6 weeks follow-up and 3, 6 and 12 months follow-up
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Post-operative complications
Tidsramme: From surgery to 30 days follow-up
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Post-operative complications will be assessed on the occurrence of at least one complication within 30 days of the procedure, specifically including neurological deficits, infections and allergic reactions.
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From surgery to 30 days follow-up
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
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Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. mars 2028
Studiet fullført (Antatt)
1. september 2028
Datoer for studieregistrering
Først innsendt
13. august 2026
Først innsendt som oppfylte QC-kriteriene
13. august 2026
Først lagt ut (Faktiske)
18. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026-A01511-50
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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