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

N/ANot Yet RecruitingNCT07770750

GCS Ramsay Santé pour l'Enseignement et la Recherche50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Lumbar Herniated Disc

Interventions

Uniportal endoscopic lumbar disc herniation removal

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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

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.

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

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.

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

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