title: Daily repetitive transcranial magnetic stimulation of primary motor cortex for neuropathic pain: a randomized, multicenter, double-blind, crossover, sham-controlled trial.
abstract: There is little evidence for multisession repetitive transcranial magnetic stimulation (rTMS) on pain relief in patients with neuropathic pain (NP), although single-session rTMS was suggested to provide transient pain relief in NP patients. We aimed to assess the efficacy and safety of 10 daily rTMS in NP patients. We conducted a randomized, double-blind, sham-controlled, crossover study at 7 centers. Seventy NP patients were randomly assigned to 2 groups. A series of 10 daily 5-Hz rTMS (500 pulses/session) of primary motor cortex (M1) or sham stimulation was applied to each patient with a follow-up of 17days. The primary outcome was short-term pain relief assessed using a visual analogue scale (VAS). The secondary outcomes were short-term change in the short form of the McGill pain questionnaire (SF-MPQ), cumulative changes in the following scores (VAS, SF-MPQ, the Patient Global Impression of Change scale [PGIC], and the Beck Depression Inventory [BDI]), and the incidence of adverse events. Analysis was by intention to treat. This trial is registered with the University hospital Medical Information Network Clinical Trials Registry. Sixty-four NP patients were included in the intention-to-treat analysis. The real rTMS, compared with the sham, showed significant short-term improvements in VAS and SF-MPQ scores without a carry-over effect. PGIC scores were significantly better in real rTMS compared with sham during the period with daily rTMS. There were no significant cumulative improvements in VAS, SF-MPQ, and BDI. No serious adverse events were observed. Our findings demonstrate that daily high-frequency rTMS of M1 is tolerable and transiently provides modest pain relief in NP patients.
authors.affiliation: Department of Neuromodulation and Neurosurgery, Office for University-Industry Collaboration, Osaka University, Osaka 565-0871, Japan.
authors.forename: Koichi
authors.initials: K
authors.lastname: Hosomi
authors.forename: Toshio
authors.initials: T
authors.lastname: Shimokawa
authors.forename: Katsunori
authors.initials: K
authors.lastname: Ikoma
authors.forename: Yusaku
authors.initials: Y
authors.lastname: Nakamura
authors.forename: Kenji
authors.initials: K
authors.lastname: Sugiyama
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Ugawa
authors.forename: Takenori
authors.initials: T
authors.lastname: Uozumi
authors.forename: Takamitsu
authors.initials: T
authors.lastname: Yamamoto
authors.forename: Youichi
authors.initials: Y
authors.lastname: Saitoh
mesh_terms: D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007564:Japan / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009044:Motor Cortex; D009437:Neuralgia / Q000175:diagnosis / Q000453:epidemiology* / Q000517:prevention & control*; D010147:Pain Measurement / Q000706:statistics & numerical data*; D015990:Placebo Effect; D015995:Prevalence; D012307:Risk Factors; D050781:Transcranial Magnetic Stimulation / Q000706:statistics & numerical data*; D016896:Treatment Outcome