Improving Disability in Knee Osteoarthritis by Targeting Neuromuscular Deficits

 描述（由申请人提供）：本R21初步和可行性临床研究提案的重点是将经皮神经电刺激（TENS）用于治疗神经肌肉激活缺陷的膝关节骨关节炎（OA）患者的神经肌肉激活的新适应症。总体目标是通过开发增强的康复策略来改善与传统治疗性运动（TE）相关的结果，该策略通过TENS（TENS+TE）增强TE，以治疗潜在的神经肌肉激活缺陷。大约75%的膝关节OA患者存在神经肌肉激活缺陷，导致残疾并阻碍TE干预可实现的力量增益。基于申请人之前在高度受控的实验室中进行的已发表工作，TENS激发神经通路，立即增加神经肌肉激活;此外，与传统TE相比，TENS+TE可持续改善膝关节OA患者的神经肌肉激活和更大的力量增益。有必要将增强的康复策略转化为以社区为基础的物理治疗（PT）诊所，其中TE通常发生，以提高膝关节OA患者非手术康复的受益。本R21的目的是报告使用TENS靶向神经肌肉激活缺陷的可行性并确定其初步效果，并增强PT诊所为膝关节OA患者提供的传统TE。我们将评估TENS+TE对肌肉力量、神经肌肉激活、步态生物力学、身体功能、身体活动、自我效能的影响。 身体活动、自我报告的生活质量、残疾和疼痛。中心假设是，增强的TENS+TE干预将导致更好的临床结果，增加体力活动，并改善总体健康状况。进行小型临床试验的基本原理是证明增强康复策略的可行性并确立其初步效果，最终为未来更大规模临床试验的开发提供信息，以确立膝关节OA增强康复策略的有效性。这一假设将通过两个具体目标进行检验：1）收集和报告进行未来随机临床试验的可行性数据，以评价在膝关节OA患者中使用TENS+ TE与假TENS+TE和仅TE相比的疗效，以及2）确定4周TENS+TE干预与假TENS+TE和仅TE相比对肌肉力量、神经肌肉激活的初步影响，步态生物力学，身体机能，身体活动，自我效能 膝关节OA患者的体力活动、自我报告的生活质量、残疾和疼痛。术后将在基线后4周和8周进行。这种方法是创新的，因为它为TENS引入了一种新的适应症，同时开发了一种新的增强型康复模式，针对神经肌肉激活缺陷，这是一种目前被传统TE忽视的损伤。从拟议的随机对照试验的结果将是显着的开发未来的临床试验，以建立证据基础的膝关节骨性关节炎康复的范式转变。

 DESCRIPTION (provided by applicant): The focus of this R21 Pilot and Feasibility Clinical Research proposal is to use transcutaneous electrical nerve stimulation (TENS) for the novel indication of treating neuromuscular activation in knee osteoarthritis (OA) patients that exhibit neuromuscular activation deficits. The overall goal is to improve outcomes associated traditional therapeutic exercise (TE) by developing an enhanced rehabilitation strategy, which augments TE with TENS (TENS+TE), for the purpose of treating underlying neuromuscular activation deficits. Approximately 75% of knee OA patients have neuromuscular activation deficits that lead to disability and impede strength gains that can be achieved with TE interventions. Based on the applicant's prior published work, conducted in a highly controlled laboratory, TENS excites neural pathways that immediately increase neuromuscular activation; also, TENS+TE produces sustained improvements in neuromuscular activation and greater strength gains in knee OA patients compared to traditional TE. There is a need to translate the enhanced rehabilitation strategy into community-based physical therapy (PT) clinics, where TE typically occurs, to improve the benefits of non-surgical rehabilitation for knee OA patients. The objective of this R21 is to report the feasibility and determine the preliminary effects of using TENS to target neuromuscular activation deficits and enhance the traditional TE provided to knee OA patients in PT clinics. We will evaluate the effect of TENS+TE on muscle strength, neuromuscular activation, gait biomechanics, physical function, physical activity, self-efficacy of physical activity, self-reported quality of life, disability and pain. The central hypothesis is tht an enhanced TENS+TE intervention will lead to better clinical outcomes, increased physical activity, and improved general health. The rationale for conducting a small clinical trial, which demonstrates the feasibility and establishes the preliminary effects of an enhanced rehabilitation strategy, is ultimately to inform the development of a future larger clinical trial to establish th efficacy of an enhanced rehabilitation strategy for knee OA. This hypothesis will be tested through two specific aims: 1) to collect and report feasibility data for conducting a future randomized clinical trial to evaluate the efficacy of using TENS+TE compared to sham TENS+TE and to TE only in patients with knee OA, and 2) to determine preliminary effects of a 4-week TENS+TE intervention compared to sham TENS+TE, and TE only on muscle strength, neuromuscular activation, gait biomechanics, physical function, physical activity, self-efficacy of physical activity, self-reported quality of life, disability, and pain in knee OA patients. Posttess will be at 4 and 8-weeks following baseline. This approach is innovative because it introduces a novel indication for TENS and simultaneously develops a new, enhanced rehabilitation paradigm that targets neuromuscular activation deficits, an impairment currently ignored by traditional TE. The results from the proposed randomized controlled trial will be significant for developing a future clinical trial to establish the evidence base for a paradigm shift in knee OA rehabilitation.