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Short-term effectiveness of Gabapentin versus Placebo in acute Lumbosacral Radiculalgia by herniation disc: a prospective, multicentric, randomized, controlled, double-blind study
EU CTIS ID: 2024-518053-42-00
What this study is testing
Evaluate the analgesic efficacy of Gabapentin versus Placebo in the short term in acute Lumbosacral Radiculalgia due to disc herniation.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Motor neurological deficit (≤ 3/5) or cauda equina syndrome (emergency surgical indications),
- Patient under guardianship or curatorship
- Pregnant or breastfeeding woman
- 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
See the full eligibility 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
- Motor neurological deficit (≤ 3/5) or cauda equina syndrome (emergency surgical indications),
- Patient under guardianship or curatorship
- Pregnant or breastfeeding woman
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.