Assesment of Epidural Platelet-Rich Plasma (PRP) Injection During Uniportal Endoscopic Lumbar Disc Herniation Excision on Residual Neuropathies (HERDISPLA)
August 18, 2026 updated by: 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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Lyon, France, 69008
- Hôpital Privé Jean Mermoz
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Contact:
- Dr Henri d'Astorg
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Presence of neuropathic pain
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)).
|
At 2 and 6 weeks follow-up and 3, 6 and 12 months follow-up
|
|
Progression of neuropathic pain
Time Frame: 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
Time Frame: 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
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))
|
At baseline, 2 and 6 weeks follow-up and 3, 6 and 12 months follow-up
|
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Progression of disability
Time Frame: 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
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
September 1, 2028
Study Registration Dates
First Submitted
August 13, 2026
First Submitted That Met QC Criteria
August 13, 2026
First Posted (Actual)
August 18, 2026
Study Record Updates
Last Update Posted (Actual)
August 20, 2026
Last Update Submitted That Met QC Criteria
August 18, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-A01511-50
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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