Post Andrew A, Rio Ebonie K, Sluka Kathleen A, Moseley G Lorimer, Bayman Emine O, Hall Mederic M, de Cesar Netto Cesar, Wilken Jason M, Danielson Jessica F, Chimenti Ruth
Department of Physical Therapy & Rehabilitation Science, University of Iowa, Iowa City, IA, United States.
School of Allied Health, La Trobe University, Bundoora, Australia.
JMIR Res Protoc. 2020 Nov 3;9(11):e19111. doi: 10.2196/19111.
Achilles tendinopathy (AT) rehabilitation traditionally includes progressive tendon loading exercises. Recent evidence suggests a biopsychosocial approach that incorporates patient education on psychosocial factors and mechanisms of pain can reduce pain and disability in individuals with chronic pain. This is yet to be examined in individuals with AT.
This study aims to compare the effects on movement-evoked pain and self-reported function of pain education as part of a biopsychosocial approach with pathoanatomical education for people with AT when combined with a progressive tendon loading exercise program.
A single-site, randomized, double-blind, placebo-controlled clinical trial will be conducted in a university-based hospital in a laboratory setting and/or by telehealth. A total of 66 participants with chronic (>3 months) midportion or insertional AT will be randomized for the Tendinopathy Education of the Achilles (TEAch) study. All participants will complete progressive Achilles tendon loading exercises over 12 weeks and will be encouraged to continue with self-selected exercises as tolerated. All participants will complete 6-7 one-to-one sessions with a physical therapist to progress exercises in a standardized manner over 8 weeks. During the last 4 weeks of the intervention, participants will be encouraged to maintain their home exercise program. Participants will be randomized to 1 of 2 types of education (pain education or pathoanatomic), in addition to exercise. Pain education will focus on the biological and psychological mechanisms of pain within a biopsychosocial framing of AT. Pathoanatomic education will focus on biological processes within a more traditional biomedical framework of AT. Evaluation sessions will be completed at baseline and 8-week follow-up, and self-reported outcome measures will be completed at the 12-week follow-up. Both groups will complete progressive Achilles loading exercises in 4 phases throughout the 12 weeks and will be encouraged to continue with self-selected exercises as tolerated. Primary outcomes are movement-evoked pain during heel raises and self-reported function (patient-reported outcome measure information system-Physical Function). Secondary outcomes assess central nervous system nociceptive processing, psychological factors, motor function, and feasibility.
Institutional review board approval was obtained on April 15, 2019, and study funding began in July 2019. As of March 2020, we randomized 23 out of 66 participants. In September 2020, we screened 267 individuals, consented 68 participants, and randomized 51 participants. We anticipate completing the primary data analysis by March 2022.
The TEAch study will evaluate the utility of pain education for those with AT and the effects of improved patient knowledge on pain, physical function, and clinical outcomes.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/19111.
跟腱病（AT）的康复传统上包括渐进性的肌腱负荷训练。最近有证据表明，采用生物心理社会方法，结合对患者进行心理社会因素及疼痛机制的教育，可减轻慢性疼痛患者的疼痛并降低其残疾程度。但这一方法在跟腱病患者中尚未得到验证。
本研究旨在比较将疼痛教育作为生物心理社会方法的一部分，与病理解剖学教育，在与渐进性肌腱负荷训练计划相结合时，对跟腱病患者运动诱发疼痛和自我报告功能的影响。
将在一所大学附属医院的实验室环境中，和/或通过远程医疗开展一项单中心、随机、双盲、安慰剂对照临床试验。共有66例慢性（>3个月）跟腱中部或止点处跟腱病患者将被随机纳入跟腱病教育（TEAch）研究。所有参与者将在12周内完成渐进性跟腱负荷训练，并鼓励他们在耐受的情况下继续进行自选训练。所有参与者将与物理治疗师进行6至7次一对一的训练，以便在8周内以标准化方式推进训练。在干预的最后4周，鼓励参与者维持其家庭训练计划。除训练外，参与者将被随机分为两种教育类型（疼痛教育或病理解剖学教育）中的一种。疼痛教育将在生物心理社会框架内聚焦于跟腱病疼痛的生物学和心理学机制。病理解剖学教育将在更传统生物医学框架内聚焦于生物学过程。评估将在基线和8周随访时完成，自我报告结局指标将在12周随访时完成。两组将在12周内分4个阶段完成渐进性跟腱负荷训练，并鼓励他们在耐受的情况下继续进行自选训练。主要结局为提踵时的运动诱发疼痛和自我报告功能（患者报告结局测量信息系统-身体功能）。次要结局评估中枢神经系统伤害性加工、心理因素、运动功能和可行性。
2019年4月15日获得机构审查委员会批准，研究资金于2019年7月开始。截至2020年3月，我们已将66名参与者中的23名随机分组。2020年9月，我们筛查了267人，68名参与者同意参与，51名参与者被随机分组。我们预计在2022年3月前完成主要数据分析。
TEAch研究将评估疼痛教育对跟腱病患者效用，以及改善患者知识对疼痛、身体功能和临床结局的影响。
国际注册报告识别码（IRRID）：DERR1-10.2196/19111
