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Not yet recruitingNCT07770750HERDISPLAUpdated Aug 20, 2026

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

An interventional study of Uniportal endoscopic lumbar disc herniation removal in Lumbar Herniated Disc, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Lumbar Herniated Disc

Keywords

  • PRP injection
  • Uniportal endoscopic
  • Lumbar Disc Herniation Excision
03

In context

Intervertebral Disc Displacement

474 studies on the registry are indexed under Intervertebral Disc Displacement; 100 are open to participants now.

This study's planned enrollment of 50 is below the median of 63 across 344 interventional studies indexed under Intervertebral Disc Displacement.

Browse Intervertebral Disc Displacement studies →

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 207 studies on the registry; 99 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form

Exclusion criteria

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 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 .
  • Pregnant or breastfeeding women, including parturient women
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Epidural PRP injection

    PRP collection and injection at the end of surgery (herniated disc removal)

    Procedure: Uniportal endoscopic lumbar disc herniation removal

Interventions

  • ProcedureUniportal endoscopic lumbar disc herniation removal

    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.

06

What researchers measure

Primary outcomes

  1. Presence of neuropathic pain

    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)).

    Time frame: At 6 months follow-up

Secondary outcomes

  1. Presence of neuropathic pain

    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)).

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

  2. Progression of neuropathic pain

    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).

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

  3. Progression of leg radicular pain

    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))

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

  4. Progression of back pain

    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))

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

  5. Progression of disability

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

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

  6. Therapeutic failure

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

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

  7. Post-operative complications

    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.

    Time frame: From surgery to 30 days follow-up

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07770750
Responsible party
Sponsor
First posted
Aug 18, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Mar 1, 2028 (estimated)
Completion
Sep 1, 2028 (estimated)
Last update
Aug 20, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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