Repetitive Transcranial Magnetic Stimulation for phantom limb pain in landmine victims: A double-blinded, randomized, sham-controlled trial

Abstract We evaluated the effects of repetitive Transcranial Magnetic Stimulation (rTMS) in the treatment of phantom limb pain (PLP) in landmine victims. Fifty-four patients with PLP were enrolled in a randomized, double-blinded placebo-controlled parallel group, single center trial. The intervention consisted in real or sham rTMS of M1 contralateral to the amputated leg. RTMS was given in series of 20 trains of 6s of duration (54 s inter-train, intensity 90% of Motor Threshold) at a stimulation rate of 10 Hz (1200 pulses), 20 minutes per day, during 10 days. For the control group, a sham coil was used. The administration of active rTMS induced a significantly greater reduction in pain intensity (Visual Analogue Scale scores) fifteen days after treatment when compared to sham stimulation (-53.38±53.12% vs -22.93±57.16%; mean between-group difference=30.44%, 95%CI 0.30, 60.58; p=0.03). This effect was not significant 30 days after treatment. In addition, 70.3% (19) of subjects attained a clinically significant pain reduction (>30%) in the active group compared to 40.7% (11) in the sham group fifteen days after treatment (p=0.03). The administration of 10 Hz rTMS on the contralateral primary motor cortex for 2 weeks in traumatic amputees with PLP induces significant clinical improvement in pain. Trial registry www.clinicaltrials.gov: Code Number: NCT01872481 Perspective High frequency rTMS on the contralateral primary motor cortex of traumatic amputees induces a clinically significant pain reduction up to 15 days after treatment without any major secondary effect. These results indicate that rTMS is a safe and effective therapy in patients with phantom limb pain caused by landmine explosions.