Evaluating Gabapentin for Acute Lumbosacral Radiculalgia
Short-term Effectiveness of Gabapentin Versus Placebo in Acute Lumbosacral Radiculalgia by Herniation Disc: a Prospective, Multicentric, Randomized, Controlled, Double-blind Study
This study is testing if Gabapentin can help hospitalized patients with severe back pain from a herniated disc feel better compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lille Catholic University Academic / other |
| Locations | 5 sites (Arras and 4 other locations) |
| Trial ID | NCT04865042 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the short-term analgesic effectiveness of Gabapentin compared to a placebo in hospitalized patients suffering from acute lumbosacral radiculalgia due to disc herniation. Participants will be randomly assigned to receive either Gabapentin or a placebo over a three-day period, with pain levels and treatment tolerance evaluated throughout. The study focuses on patients with moderate to severe pain and confirmed disc herniation, ensuring a targeted approach to pain management.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with acute lumbosacral radiculalgia lasting less than three months and moderate to severe pain.
Not a fit: Patients with significant motor deficits, chronic neuropathic pain, or recent lumbar interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective pain management option for patients suffering from acute lumbosacral radiculalgia.
How similar studies have performed: Previous studies have shown promising results for Gabapentin in managing neuropathic pain, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years, * Radiculalgia or lumboradiculalgia less than 3 months (pain of a lower limb systematized to a radicular territory, possibly associated with lumbar pain), * Inpatient management for a minimum of 72 hours after inclusion, * Initial radiculalgia VAS ≥ 4 (moderate to severe pain), * Concordant disc herniation between clinical symptomatology and imaging (CT or MRI) less than 3 months, * Written consent signed by the patient, * Affiliation to a social security system * For women of childbearing age, use of effective contraception Exclusion Criteria: * Motor neurological deficit (≤ 3/5) or cauda equina syndrome (emergency surgical indications), * Chronic neuropathic pain in the lower limb affected by radiculalgia, * Lumbar infiltration performed within 72 hours prior to inclusion or unable to be performed after 72 hours, * Patient already on Gabapentin or Pregabalin, or having taken these treatments in the 7 days prior to inclusion * Contraindication to Gabapentin (Hypersensitivity to the active substance or to any of the excipients: corn starch, talc, yellow iron oxide, titanium dioxide, sodium lauryl sulfate, gelatin, shellac, propylene glycol, black iron oxide and potassium hydroxide) * Creatinine clearance \< 30ml/min, * Hemodialysis patient, * Body weight \< 50kgs, * Transplant patient * Patient under guardianship or curatorship * Pregnant or breastfeeding woman
Where this trial is running
Arras and 4 other locations
- CH Arras-rheumatology — Arras, France (Recruiting)
- CH Béthune-rheumatology — Béthune, France (Recruiting)
- CHU Caen-rheumatology — Caen, France (Recruiting)
- CH Dunkerque-rheumatology — Dunkerque, France (Recruiting)
- CHU Rouen-rheumatology — Rouen, France (Recruiting)
Study contacts
- Study coordinator: Marie-Paule LEBITASY
- Email: urm@ghicl.net
- Phone: +33 3 20 22 52 69
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.