OBJECTIVE: The aim of this study was to evaluate whether early treatment with carbamazepine decreases the incidence of neuropathic pain (NP) or its intensity in patients with spinal cord injury. DESIGN: This study was a randomized, double-blind, placebo-controlled clinical trial at a third-level university hospital involving patients older than 18 yrs with a diagnosis of spinal cord injury sustained within 2 wks before enrollment and without evidence of NP. The patients received either carbamazepine up to 600 mg/day or placebo for 1 mo. Pain intensity was measured with a 10-cm visual analog scale and the SF-36 bodily pain subscale; quality-of-life, with the Short Form 36 (SF-36) Scale; and depression, with the Zung Self-Rating Depression Scale. Measurements were carried out at the start of the randomized trial and at the 1-, 3-, and 6-month follow-up assessments. RESULTS:Twenty-one of 46 patients developed NP. At the 1-, 3-, and 6-month follow-up assessments, NP was present in 4, 11, and 10 patients of the carbamazepine group and in 8, 9, and 8 patients of the placebo group, respectively. At 1 mo, two patients in the carbamazepine group vs. eight patients in the placebo group reported moderate/intense pain (visual analog scale, ≥4.0; P = 0.024). At the 3- and 6-month follow-up appointments, moderate/intense pain was reported by eight vs. six (P = 0.498) and six vs. eight patients (P = 0.298), carbamazepine and placebo group, respectively. There was no difference in the depression ratings or in any of the SF-36 scales. CONCLUSIONS: Early intervention with carbamazepine decreased NP incidence at the 1-month but not at the 3- and 6-month follow-ups in the group of patients with acquired spinal cord injury.
RCT Entities:
OBJECTIVE: The aim of this study was to evaluate whether early treatment with carbamazepine decreases the incidence of neuropathic pain (NP) or its intensity in patients with spinal cord injury. DESIGN: This study was a randomized, double-blind, placebo-controlled clinical trial at a third-level university hospital involving patients older than 18 yrs with a diagnosis of spinal cord injury sustained within 2 wks before enrollment and without evidence of NP. The patients received either carbamazepine up to 600 mg/day or placebo for 1 mo. Pain intensity was measured with a 10-cm visual analog scale and the SF-36 bodily pain subscale; quality-of-life, with the Short Form 36 (SF-36) Scale; and depression, with the Zung Self-Rating Depression Scale. Measurements were carried out at the start of the randomized trial and at the 1-, 3-, and 6-month follow-up assessments. RESULTS: Twenty-one of 46 patients developed NP. At the 1-, 3-, and 6-month follow-up assessments, NP was present in 4, 11, and 10 patients of the carbamazepine group and in 8, 9, and 8 patients of the placebo group, respectively. At 1 mo, two patients in the carbamazepine group vs. eight patients in the placebo group reported moderate/intense pain (visual analog scale, ≥4.0; P = 0.024). At the 3- and 6-month follow-up appointments, moderate/intense pain was reported by eight vs. six (P = 0.498) and six vs. eight patients (P = 0.298), carbamazepine and placebo group, respectively. There was no difference in the depression ratings or in any of the SF-36 scales. CONCLUSIONS: Early intervention with carbamazepine decreased NP incidence at the 1-month but not at the 3- and 6-month follow-ups in the group of patients with acquired spinal cord injury.
Authors: Jorge Baruch Pineda-Farias; Emanuel Loeza-Alcocer; Vidhya Nagarajan; Michael S Gold; Raymond F Sekula Journal: J Neurosci Date: 2021-08-26 Impact factor: 6.167