The Efficacy of Fundamental Advice and a Heel Cup Versus Fundamental Advice and a Heel Cup Plus eXercise Versus Fundamental Advice and a Heel Cup Plus Exercise and a Corticosteroid Injection in Individuals With Plantar Fasciopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change in Foot Health Status Questionnaire pain domain
研究概览
简要总结
The purpose of this trial is to investigate the efficacy of fundamental patient advice and a heel cup versus fundamental patient advice and a heel cup plus heavy-slow resistance training versus fundamental patient advice and a heel cup plus heavy-slow resistance training and an ultrasound-guided corticosteroid injection in improving the Foot Health Status Questionnaire pain domain score in individuals with plantar fasciopathy after 12 weeks.
详细描述
This trial will be designed as a randomised, data analyst-blinded, superiority trial, with a 3-group parallel design to be conducted in Aalborg, Denmark. Reporting of the trial will follow CONSORT guidelines and TIDieR for intervention description. Reporting of the protocol will follow the SPIRIT statement. The planning of the trial is done in accordance with the PREPARE Trial guide.
Participants will be stratified by sex and block randomised in block sizes of 3 to 12 (1:1:1) into 3 parallel groups of 60 participants using a random number generator on www.sealedenvelope.com. The block sizes will be random and concealed to the research assistants responsible of including participants. Group allocation will be coded, and the data analyst will be blinded to this code until after the analyses have been performed.
The investigators will only conclude superiority of one intervention over the other if the intention-to-treat analysis leads to mean between-group differences of the Foot Health Status Questionnaire pain domain ≥14 points (minimally important difference) and P-values <0.05 at the primary endpoint (12 weeks) after adjustment for the baseline value.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Analyses will be carried out by a blinded data analyst
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of inferior heel pain for at least three months before enrolment
- •pain on palpation of the medial calcaneal tubercle or the proximal plantar fascia
- •thickness of the plantar fascia of 4.0 mm or greater as measured by ultrasonography
- •mean heel pain of ≥30 mm on a 100 mm VAS during the previous week
排除标准
- •below 18 years of age
- •history of inflammatory systemic diseases
- •pregnancy or breastfeeding
- •corticosteroid injection for plantar fasciopathy within the previous six months
- •pain or stiffness in the 1st metatarsophalangeal joint to an extent where the exercises cannot be performed
- •known hypersensitivity to corticosteroids or local anaesthetics
- •skin or soft tissue infection near the injection site
- •received treatment by a healthcare professional for plantar fasciopathy within the previous 12 weeks
- •made any substantial changes to usual self-care of the condition in the last 4 weeks (e.g. started using insoles, started performing stretching, made a substantial decrease in physical activity level)
研究组 & 干预措施
Fundamental advice and a heel cup
干预措施: Fundamental advice and a silicone heel cup (Other)
Fundamental advice and a heel cup plus exercise
干预措施: Heavy-slow resistance training (Other)
Fundamental advice and a heel cup plus exercise
干预措施: Fundamental advice and a silicone heel cup (Other)
Fundamental advice and a heel cup plus exercise and injection
干预措施: Ultrasound-guided corticosteroid injection (Drug)
Fundamental advice and a heel cup plus exercise and injection
干预措施: Heavy-slow resistance training (Other)
Fundamental advice and a heel cup plus exercise and injection
干预措施: Fundamental advice and a silicone heel cup (Other)
结局指标
主要结局
Change in Foot Health Status Questionnaire pain domain
时间窗: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
The Foot Health Status Questionnaire is a self-report questionnaire ranging from 0 (poor foot health) to 100 (optimum foot health) that assesses multiple dimensions of foot health and function. A validated Danish translation of the original questionnaire will be used.
次要结局
- Global Rating of Change(At follow-ups after 12, 26 and 52 weeks)
- Change in Pain Self-Efficacy Questionnaire score(During baseline and at follow-ups after 4, 12, 26 and 52 weeks)
- Change in Foot Health Status Questionnaire general foot health domain(During baseline and at follow-ups after 4, 12, 26 and 52 weeks)
- Time to Patient Acceptable Symptom State(From 0 to 52 weeks)
- Change in Foot Health Status Questionnaire footwear domain(During baseline and at follow-ups after 4, 12, 26 and 52 weeks)
- Change in weekly light, moderate and vigorous physical activity level expressed as Metabolic Equivalents(Week 1 and Week 13 of the interventions)
- Change in self-reported health state as measured by the EQ-5D-5L(During baseline and at follow-ups after 4, 12, 26 and 52 weeks)
- Change in Foot Health Status Questionnaire function domain(During baseline and at follow-ups after 4, 12, 26 and 52 weeks)
研究者
Henrik Riel
PhD student
Aalborg University