Lumbar Herniated Disc
Conditions
Keywords
PRP injection, Uniportal endoscopic, Lumbar Disc Herniation Excision
Brief 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.
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.
Sponsors
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of neuropathic pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Progression of leg radicular pain | 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)) |
| Progression of back pain | 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)) |
| Progression of disability | 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) |
| Progression of neuropathic pain | 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). |
| Post-operative complications | 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. |
| Presence of neuropathic pain | 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)). |
| Therapeutic failure | 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. |
Countries
France
Outcome results
None listed