Herniated DiscNCT07036445
Comparison of Interlaminar CT Guided Epidural Platelet Rich Plasma Versus Steroid Injection in Patients With Lumbar Radicular Pain
A study testing Epidural Steroid Injection and Epidural platelet-rich plasma injection in people with Herniated Disc, run by Clinique du Sport, Bordeaux Mérignac at 1 site in France.
Trial summary
The treatment of persistent lumbar radicular pain (LRP) using CT-guided epidural steroid injection (ESI) is widely used and associated with rare but serious complications. Platelet-rich plasma (PRP), which has recently been shown to promote healing and the anti-inflammatory process by delivering growth factors and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herniated Disc
- What is being tested?
- Epidural Steroid Injection and Epidural platelet-rich plasma injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 11 Sep 2025to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of unilateral resistant LRP associated with a herniated disc on MRI images. (Diagnosis of resistance after 6 weeks of appropriate medical treatment).
Who cannot join
- Patients with infections,
- Patients who have had previous percutaneous corticosteroid injections,
- Patients undergoing systemic corticosteroid treatment,
- Patients with immune deficiencies,
- Patients who are allergic to the contrast medium used,
- Pregnant or breastfeeding patients,
Show all 9Show fewer
- Patients with a history of allergies to anesthetics or corticosteroids,
- Anticoagulant treatment or blood disorders, patients on antiplatelet therapy
- Taking NSAIDs within two weeks prior to the procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique du Sport
Mérignac, 33700
Marion Mandon, PhD, +33 (0)6 78 27 76 72, mmandon@vivalto-sante.com
About this study
Official title: Comparison of Interlaminar CT Guided Epidural Platelet Rich Plasma Versus Steroid Injection in Patients With Lumbar Radicular Pain : a Prospective Study With Long Term Follow up
The treatment of persistent lumbar radicular pain (LRP) using CT-guided epidural steroid injection (ESI) is widely used and associated with rare but serious complications. Platelet-rich plasma (PRP), which has recently been shown to promote healing and the anti-inflammatory process by delivering growth factors and cytokines, could be an alternative and potentially safer option. A previous study showed that PRP was as effective as ESI in treating this condition, without major complications.
This study aims to compare these two treatments over the long term (2 years).
- Conditions
- Herniated Disc
- Being tested
- Epidural Steroid Injection, Epidural platelet-rich plasma injection
- 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.
Epidural Steroid InjectionProcedure or surgery
Intervention consists of interlaminar CT guided epidural steroid injection
Epidural platelet-rich plasma injectionProcedure or surgery
Intervention consists of interlaminar CT guided epidural platelet-rich plasma injection after recovery of plasma by blood sampling and centrifugation
| Study group | Role | What they receive |
|---|---|---|
| steroid treatment | Active comparator | Not described Receives: Procedure: Epidural Steroid Injection |
| platelet-rich plasma treatment | Experimental | Not described Receives: Procedure: Epidural platelet-rich plasma injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional ability
Oswestry Disability Questionnaire ranging from 0 to 100%
Measured: 30 minutes before procedure ; 6 weeks after procedure ; 6 months, 1 year, 2 years after procedure
Secondary outcomes (1)
Pain evaluation
Numerical pain rating scale (NRS): intensity of combined pain in the legs and back ranging from 0 to 10
Measured: 6 weeks, 6 months, 1 year and 2 years after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start11 Sep 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herniated DiscStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique du Sport, Bordeaux Mérignac
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036445
- Sponsor's protocol ID
- 2024-38-SBM
- Status last verified
- Sep 2025
- First submitted
- 17 Jun 2025
- Last updated
- 18 Sep 2025
- 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 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Interlaminar CT Guided Epidural Platelet Rich Plasma Versus Steroid Injection in Patients With Lumbar Radicular Pain : a Prospective Study With Long Term Follow up
- ClinicalTrials.gov ID
- NCT07036445
- Acronym / sponsor ID
- 2024-38-SBM
- Conditions
- Herniated Disc
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Clinique du Sport, Bordeaux MérignacUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Jun 2025 (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 treatment of persistent lumbar radicular pain (LRP) using CT-guided epidural steroid injection (ESI) is widely used and associated with rare but serious complications. Platelet-rich plasma (PRP), which has recently been shown to promote healing and the anti-inflammatory process by delivering growth factors and cytokines, could be an alternative and potentially safer option. A previous study showed that PRP was as effective as ESI in treating this condition, without major complications.
This study aims to compare these two treatments over the long term (2 years).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| steroid treatment | Active comparator | Procedure: Epidural Steroid Injection |
| platelet-rich plasma treatment | Experimental | Procedure: Epidural platelet-rich plasma injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of unilateral resistant LRP associated with a herniated disc on MRI images. (Diagnosis of resistance after 6 weeks of appropriate medical treatment).
Key exclusion criteria (9 listed)
- Patients with infections,
- Patients who have had previous percutaneous corticosteroid injections,
- Patients undergoing systemic corticosteroid treatment,
- Patients with immune deficiencies,
- Patients who are allergic to the contrast medium used,
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 |
|---|---|---|
| Epidural Steroid InjectionIntervention consists of interlaminar CT guided epidural steroid injection | Procedure or surgery | steroid treatment |
| Epidural platelet-rich plasma injectionIntervention consists of interlaminar CT guided epidural platelet-rich plasma injection after recovery of plasma by blood sampling and centrifugation | Procedure or surgery | platelet-rich plasma treatment |
Primary outcome
Functional ability
Time frame: 30 minutes before procedure ; 6 weeks after procedure ; 6 months, 1 year, 2 years after procedure
Oswestry Disability Questionnaire ranging from 0 to 100%
1 secondary outcome
Pain evaluation
Time frame: 6 weeks, 6 months, 1 year and 2 years after procedure
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 18 Sep 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural Steroid Injection and Epidural platelet-rich plasma injection in people with Herniated Disc, run by Clinique du Sport, Bordeaux Mérignac 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 1 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 18 Sep 2025. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional ability (time frame: 30 minutes before procedure ; 6 weeks after procedure ; 6 months, 1 year, 2 years after procedure). 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 18 Sep 2025.