背景:四头肌训练对膝骨关节炎(KOA)患者的功能和日常生活活动能力是必要的。然而,长期来看,这并没有降低终末期KOA的手术治疗率.这可能与KOA患者的大脑结构改变和适应可塑性不良有关。经颅磁刺激(TMS)可以增强脑区的功能连接并改善适应性可塑性。然而,两者联合治疗KOA的协同作用尚不清楚.因此,本研究的目的是探讨高频rTMS联合股四头肌力量训练是否比单纯股四头肌训练更有效地改善KOA的疼痛和功能,并探讨其作用机制。
方法:这项研究是一项评估盲,假控制,包括12周干预和6个月随访的随机对照试验。148名KOA参与者将接受常规护理管理,并平均随机分为四个亚组,包括股四头肌力量训练,高频rTMS训练,假rTMS和股四头肌力量训练,高频rTMS和股四头肌力量训练。康复干预措施将每周进行5天,共12周。所有结果将在基线测量,4周,8周,干预期间12周和1个月,随访3个月和6个月。有效性结果将包括视觉模拟量表,等速膝关节肌肉力量,膝关节损伤和骨关节炎结果评分和36项短期健康调查评分;行为机制结果将包括运动诱发电位,灰质密度,白质,皮质下核体积,通过MRI检查皮质厚度和功能连通性。具有重复测量的双向方差将用于测试结果测量的组和时间效应。
结论:该研究将是第一个研究高频rTMS联合股四头肌力量训练治疗KOA后是否存在协同作用并阐明作用机制的方案。如果证明有效,可以将高频rTMS添加到KOA患者的培训计划中。
背景:中国临床试验注册ChiCTR2300067617。注册于2013年1月23日。
BACKGROUND: Quadriceps training is necessary in function and activity of daily living for patients with knee osteoarthritis (KOA). However, it did not reduce the rate of surgical treatment for end-stage KOA in the long term. This may be related to brain structure changes and maladaptive plasticity in KOA patients. Transcranial Magnetic Stimulation (TMS) could enhance the functional connectivity of brain regions and improves maladaptive plasticity. However, the synergistic effect of the combination of the two for treat KOA is still unclear. Therefore, the purpose of this
study is to investigate whether the High-Frequency rTMS combined with quadriceps strength training can improve the pain and function in KOA more effectively than quadriceps training alone and explore the mechanism of action.
METHODS: This
study is an assessor-blind, sham-controlled, randomized controlled
trial involving 12 weeks of intervention and 6 months follow-up. 148 participants with KOA will receive usual care management and be randomized into four subgroups equally, including quadriceps strength training, high-frequency rTMS training, sham rTMS and quadriceps strength training, high-frequency rTMS and quadriceps strength training. The rehabilitation interventions will be carried out 5 days per week for a total of 12 weeks. All outcomes will be measured at baseline, 4 weeks, 8 weeks, and 12 weeks during the intervention and 1 month, 3 months and 6 months during the follow-up period. The effectiveness outcomes will be included visual analog scale, isokinetic knee muscle strength, Knee Injury and Osteoarthritis Outcome score and 36-Item Short-Form Health Survey score; The act mechanism outcomes will be included motor evoked potential, grey matter density, white matter, subcortical nuclei volumes, cortical thickness and functional connectivity by MRI. Two-way of variance with repeated measures will be used to test the group and time effect for outcome measures.
CONCLUSIONS: The
study will be the first protocol to examine whether there are synergistic effects following high-frequency rTMS combined with quadriceps strength training for treat KOA and clarify the mechanism of action. High-frequency rTMS can be added into the training program for KOA patients if it is proven effective.
BACKGROUND: Chinese Clinical
Trial Registry ChiCTR2300067617. Registered on Jan.13,2023.