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重复经颅磁刺激对比镜像疗法治疗截肢后幻肢痛的随机对照研究

Randomized Controlled Trial of the Effects of Repetitive Transcranial Magnetic Stimulation and Mirror Therapy on Phantom Limb Pain in Amputees

  • 摘要:
      目的  探讨重复经颅磁刺激(repetitive transcranial magnetic stimulation, rTMS)对截肢患者幻肢痛的影响,并与镜像疗法(mirror therapy, MT)进行比较。
      方法  本研究采用随机对照试验设计,评估者盲,受试者和治疗师非盲。通过计算机生成随机数字表,将受试者随机分配到rTMS组或MT组。2018年6月–2020年12月期间,从四川大学华西医院康复医学中心的45例截肢患者中筛查出符合研究标准的30例纳入研究。4例中途退出,最终26例完成规定治疗和评估(rTMS组12例,MT组14例)。rTMS组在常规康复治疗的基础上,还接受为期2周的重复经颅磁刺激(1 Hz,15 min,5 d/周),MT组在常规康复治疗的基础上,还接受为期2周的镜像疗法(肢体相应动作,15 min, 5 d/周)。结局指标为基础疼痛视觉模拟评分(visual analogue scale, VAS)和神经病理性疼痛四问(Douleur Neuropathique 4 questions, DN-4)。在治疗前(t0)、治疗结束后即刻(t1)、治疗结束后3个月(t2)对受试者进行疼痛评估。
      结果  26例患者平均年龄(39.73±12.64)岁,男性15例,女性11例。纳入的截肢患者对幻肢痛特征描述中,总体发生率最高的依次是麻刺感、刀割感、麻木感、放电感和灼烧感;两组间幻肢痛特征发生率差异无统计学意义(P>0.05)。两组基线可比,VAS和DN-4在t0差异无统计学意义(P>0.05)。两组患者t1t2的VAS和DN-4较t0降低,差异均有统计学意义(P均<0.01);rTMS组患者t2的VAS和DN-4与t1相当,差异均无统计学意义(P>0.05);MT组患者t2的VAS和DN-4低于t1,差异均有统计学意义(P<0.05)。两组间治疗前后各时点VAS和DN-4疼痛差值差异均无统计学意义(P>0.05)。26例完成试验的患者在研究过程中未见头晕、头痛等异常。
      结论  rTMS对截肢患者幻肢痛有改善作用,但其改善作用与镜像疗法相当。

     

    Abstract:
      Objective  To investigate the effect of repetitive transcranial magnetic stimulation (rTMS) on phantom limb pain (PLP) in amputees, and to compare the therapeutic effect with that of mirror therapy (MT).
      Methods  The study was designed as a randomized controlled trial. The evaluators were blinded, while the subjects and the therapists were unblinded. Subjects were randomly assigned to either the rTMS group or the MT group with a computer-generated random number table. From June 2018 to December 2020, from out of 45 amputee patients screened for the study, 30 who met the inclusion criteria were recruited for the study. All patients were recruited from the Rehabilitation Medicine Center, West China Hospital, Sichuan University. In the end, 4 patients withdrew from the study and 26 patients (12 in the rTMS group and 14 in the MT group) completed the prescribed treatment and evaluation. The rTMS group was given rTMS (1 Hz, 15 min, 5 d/week) for 2 weeks in addition to conventional rehabilitation therapy, while the MT group received MT (corresponding movements of limbs, 15 min, 5 d/week) for 2 weeks in addition to conventional rehabilitation therapy. PLP was evaluated by the Visual Analogue Scale (VAS) and Douleur Neuropathique 4 Questions (DN-4). Subjects were assessed before treatment (t0), immediately after the completion of the treatment (t1) and 3 months after the completion of the treatment (t2).
      Results  The mean age of the 26 patients was 39.73±12.64. There were 15 males and 11 females. According to the reported description of the characteristics of the PLP by the patients, the characteristics with the highest incidence were tingling, stabbing, numbing, electric shocks and burning in descending order. There was no significant difference in the incidence of PLP characteristics between the two groups (P>0.05). The two groups had comparable baseline data, showing no significant difference in VAS and DN-4 between the two groups at t0 (P>0.05). At t1 and t2, the VAS and DN-4 scores were decreased from those of t0, showing statistically significant difference in both groups (P<0.01 for both scores). In the rTMS group, there was no significant difference between VAS and DN-4 scores at t1 and those at t2 (P>0.05). In the MT group, the VAS and DN-4 scores at t2 were significantly lower than those of t1 (P<0.05). There was no statistically significant difference between the rTMS group and MT group in the changes in pain measurements, i.e., VAS and DN-4 scores, before and after the intervention (P>0.05). The 26 patients who completed the experiment showed no dizziness, headache, or other abnormalities during the study.
      Conclusion  The results of this study indicate that repetitive transcranial magnetic stimulation could improve PLP in amputees, and the improvement effect was comparable to that of mirror therapy.

     

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