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NCT Number: NCT07770750

Assesment of Epidural Platelet-Rich Plasma (PRP) Injection During Uniportal Endoscopic Lumbar Disc Herniation Excision on Residual Neuropathies

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.

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Key information

Conditions

Lumbar Herniated Disc Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Privé Jean Mermoz

Lyon, 69008, France

Location contact

Dr Henri d'Astorg

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Uniportal endoscopic lumbar disc herniation removal

Procedure

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.

Primary outcomes

  1. Presence of neuropathic pain

    Time frame: At 6 months follow-up

    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)).

Secondary outcomes

  1. Presence of neuropathic pain

    Time frame: At 2 and 6 weeks follow-up and 3, 6 and 12 months follow-up

    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)).

  2. Progression of neuropathic pain

    Time frame: At baseline, 2 and 6 weeks follow-up and 3, 6 and 12 months follow-up

    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).

  3. Progression of leg radicular pain

    Time frame: At baseline, 2 and 6 weeks follow-up and 3, 6 and 12 months follow-up.

    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))

  4. Progression of back pain

    Time frame: At baseline, 2 and 6 weeks follow-up and 3, 6 and 12 months follow-up

    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))

  5. Progression of disability

    Time frame: At baseline, 2 and 6 weeks follow-up, and 3, 6 and 12 months follow-up.

    Progression of disability will be assessed by ODI questionnaire. Minimum value is 0, maximum value is 50 (maximum disability)

  6. Therapeutic failure

    Time frame: At 2 and 6 weeks follow-up and 3, 6 and 12 months follow-up

    Therapeutic failure will be assessed by presence or absence of additional surgery for persistent or worsening pain.

  7. Post-operative complications

    Time frame: From surgery to 30 days follow-up

    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.

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

Assesment of Epidural Platelet-Rich Plasma (PRP) Injection During Uniportal Endoscopic Lumbar Disc Herniation Excision on Residual Neuropathies: An Exploratory Study.

Acronym: HERDISPLA

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 18, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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