Short-term effectiveness of Gabapentin versus Placebo in acute Lumbosacral Radiculalgia by herniation disc: a prospective, multicentric, randomized, controlled, double-blind study (GRADE)

lumbosacral radiculalgia

Change in radiculalgia Visual Analogue Scale (VAS) between D1 and D4, D1 corresponding to the 1st dose of treatment administered (Gabapentin or Placebo). In addition, the responder rate at D4 (= radiculalgia pain VAS < 40/100) will also be calculated, but only the change in radiculalgia VAS will be used to conclude on the efficacy of the 2 treatments (Gabapentin or Placebo).

Rate of patients presenting at least one adverse event (all types and grades) between D1 and D7: According to National Cancer Institute Common terminology criteria for adverse events (NCI CTCAE) v4.0, Change in VAS for low back pain between D1 and D4, and responder rate at D4 (= VAS for low back pain < 40/100), Change in radiculalgia VAS and low back pain VAS between Day 1 and Day 7 (time interval including Day 2, Day 3 and Day 4), Change in NPSI (Neuropathic Pain Symptom Inventory) between Day 1 and Day 4, then between Day 1 and Day 7, Change in radiculalgia VAS between Day 1 and Day 4, and again between Day 1 and Day 7, depending on the initial positivity of the dn4 (neuropathic pain screening questionnaire)., Number of interdoses of anti-nociceptive analgesics between Day 1 and Day 4 and rate of patients using at least one interdose between Day 1 and Day 4., Rate of patients who reduced the associated anti-nociceptive analgesic treatment (reduction in dosage or step or discontinuation) between Day 4 and Day 7., Links between consumption of antidepressants and antiepileptics (yes/no), and radiculalgia pain VAS at D4, if numbers permit in the Gabapentin group.

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