Lumbar Herniated DiscHERDISPLANCT07770750
Assesment of Epidural Platelet-Rich Plasma (PRP) Injection During Uniportal Endoscopic Lumbar Disc Herniation Excision on Residual Neuropathies
A study testing Uniportal endoscopic lumbar disc herniation removal in people with Lumbar Herniated Disc, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Lumbar Herniated Disc
- What is being tested?
- Uniportal endoscopic lumbar disc herniation removal
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2026to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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°.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Lumbar Herniated Disc
- Being tested
- Uniportal endoscopic lumbar disc herniation removal
- Keywords
- PRP injection, Uniportal endoscopic, Lumbar Disc Herniation Excision
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uniportal endoscopic lumbar disc herniation removalProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Epidural PRP injection | Experimental | PRP collection and injection at the end of surgery (herniated disc removal) Receives: Procedure: Uniportal endoscopic lumbar disc herniation removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)).
Measured: At 6 months follow-up
Secondary outcomes (7)
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)).
Measured: At 2 and 6 weeks follow-up and 3, 6 and 12 months follow-up
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).
Measured: At baseline, 2 and 6 weeks follow-up and 3, 6 and 12 months follow-up
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))
Measured: At baseline, 2 and 6 weeks follow-up and 3, 6 and 12 months follow-up.
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))
Measured: At baseline, 2 and 6 weeks follow-up and 3, 6 and 12 months follow-up
Progression of disability
Progression of disability will be assessed by ODI questionnaire. Minimum value is 0, maximum value is 50 (maximum disability)
Measured: At baseline, 2 and 6 weeks follow-up, and 3, 6 and 12 months follow-up.
Therapeutic failure
Therapeutic failure will be assessed by presence or absence of additional surgery for persistent or worsening pain.
Measured: At 2 and 6 weeks follow-up and 3, 6 and 12 months follow-up
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.
Measured: From surgery to 30 days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Herniated DiscStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770750
- Sponsor's protocol ID
- 2026-A01511-50
- Acronym
- HERDISPLA
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of Epidural Platelet-Rich Plasma (PRP) Injection During Uniportal Endoscopic Lumbar Disc Herniation Excision on Residual Neuropathies: An Exploratory Study.
- ClinicalTrials.gov ID
- NCT07770750
- Acronym / sponsor ID
- HERDISPLA / 2026-A01511-50
- Conditions
- Lumbar Herniated Disc
- Keywords
- PRP injection, Uniportal endoscopic, Lumbar Disc Herniation Excision
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epidural PRP injection | Experimental | Procedure: Uniportal endoscopic lumbar disc herniation removalPRP collection and injection at the end of surgery (herniated disc removal) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uniportal endoscopic lumbar disc herniation removalPRP 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. | Procedure or surgery | Epidural PRP injection |
Primary outcome
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)).
7 secondary outcomes
Presence of neuropathic pain
Time frame: 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
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 back pain
Time frame: At baseline, 2 and 6 weeks follow-up and 3, 6 and 12 months follow-up
Progression of disability
Time frame: At baseline, 2 and 6 weeks follow-up, and 3, 6 and 12 months follow-up.
Therapeutic failure
Time frame: At 2 and 6 weeks follow-up and 3, 6 and 12 months follow-up
Post-operative complications
Time frame: From surgery to 30 days follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uniportal endoscopic lumbar disc herniation removal in people with Lumbar Herniated Disc, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of neuropathic pain (time frame: At 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.