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Foot exercise plus education versus wait and see for the treatment of plantar heel pain (FEET trial): a protocol for a feasibility study
Journal of Foot and Ankle Research ( IF 2.9 ) Pub Date : 2020-05-08 , DOI: 10.1186/s13047-020-00384-1
Melinda M Franettovich Smith 1 , Natalie J Collins 1, 2 , Rebecca Mellor 1 , Alison Grimaldi 1, 3 , James Elliott 4, 5 , Mark Hoggarth 5 , Kenneth A Weber Ii 6 , Bill Vicenzino 1
Affiliation  

Background Plantar heel pain (PHP) is present in a wide range of individuals and creates significant burden to quality of life and participation in physical activity. The high recurrence rates and persistence of PHP suggests current management options may not address all potentially modifiable factors associated with the condition. Reports of intrinsic foot muscle (IFM) atrophy in individuals with PHP, together with biomechanical evidence of their important contribution to optimal foot function, suggests that an intervention focused on IFM training may be beneficial in managing PHP. We will test the feasibility of a prospective, assessor-blinded, parallel-group, randomised clinical trial that compares foot exercise plus education to brief advice in individuals with PHP. Methods Twenty participants with PHP will be randomly allocated to one of two groups for a 12-week intervention period: (i) foot exercise plus education, or (ii) brief advice. The foot exercise plus education group will attend eight sessions with a physiotherapist and receive detailed education on self-management strategies as well as a progressive exercise program for the IFMs. The brief advice group will attend one session with a physiotherapist and receive brief information about self-management strategies and reassurance. Outcome measures will be obtained at baseline and the primary end-point of 12 weeks. Primary outcomes will be the feasibility of conducting a full-scale randomised clinical trial (RCT), and the credibility and acceptability of the foot exercise plus education intervention. Secondary outcomes will explore treatment effects, which will consist of pain, physical function, physical activity level, pain self-efficacy, perceived treatment effect, magnetic resonance and ultrasound image measurement of IFM morphology, ultrasound imaging measurement of plantar fascia thickness, IFM motor performance, foot posture, foot mobility, ankle dorsiflexion range of motion, toe flexor and plantar flexor strength/endurance. Discussion To reduce the burden of PHP on individuals and society, there is a need to establish effective treatments that are feasible and accepted by patients and health professionals. This trial will be the first to evaluate the feasibility of conducting a full-scale RCT, as well as the credibility, acceptability, and treatment effects, of education and foot exercise for PHP. The findings of this study will inform the development of a full-scale RCT. Trial registration The trial protocol was prospectively registered with the Australia and New Zealand Clinical Trial Registry ( ACTRN12619000987167 ) on 11th July 2019.

中文翻译:

足部运动加教育与观望治疗足跟痛(FEET 试验):可行性研究方案

背景足底足跟痛 (PHP) 存在于广泛的个体中,对生活质量和体育活动的参与造成重大负担。PHP 的高复发率和持续性表明当前的管理选项可能无法解决与该病症相关的所有潜在可改变因素。PHP 患者内在足部肌肉 (IFM) 萎缩的报告,以及他们对最佳足部功能的重要贡献的生物力学证据,表明以 IFM 训练为重点的干预措施可能有助于管理 PHP。我们将测试一项前瞻性、评估者盲法、平行组、随机临床试验的可行性,该试验将足部锻炼加教育与 PHP 患者的简要建议进行比较。方法 20 名 PHP 参与者将被随机分配到两组中的一组进行 12 周的干预:(i) 足部锻炼加教育,或 (ii) 简要建议。足部锻炼加教育小组将与物理治疗师一起参加八次会议,并接受有关自我管理策略的详细教育以及针对 IFM 的渐进式锻炼计划。简短的建议小组将与物理治疗师一起参加一次会议,并获得有关自我管理策略和安慰的简要信息。结果测量将在基线和 12 周的主要终点获得。主要结果将是进行全面随机临床试验 (RCT) 的可行性,以及足部锻炼加教育干预的可信度和可接受性。次要结果将探索治疗效果,包括疼痛、身体机能、身体活动水平、疼痛自我效能感、治疗效果感知、IFM 形态的磁共振和超声图像测量、足底筋膜厚度的超声成像测量、IFM 运动性能、足部姿势、足部活动度、踝关节背屈运动范围、脚趾屈肌和足底屈肌力量/耐力。讨论 为了减轻 PHP 对个人和社会的负担,需要建立可行且被患者和卫生专业人员接受的有效治疗方法。该试验将首次评估进行全面 RCT 的可行性,以及 PHP 教育和足部锻炼的可信度、可接受性和治疗效果。这项研究的结果将为全面 RCT 的发展提供信息。
更新日期:2020-05-08
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