Clinical and Economic Effectiveness of Barefoot Walking Compared to Standardised Conservative Care for the Treatment of Plantar Fasciopathy: a Pragmatic Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- First-Step Pain
研究概览
简要总结
The goal of this clinical trial is to learn if a barefoot walking programme can treat plantar fasciopathy (heel pain) in adults aged 18-70. The main questions it aims to answer are:
- Does a barefoot walking programme reduce heel pain compared to a standardised stretching and strengthening programme?
- Does a barefoot walking programme improve foot function and quality of life in adults with plantar fasciopathy?
Researchers will compare a barefoot walking programme to a standardised stretching and strengthening programme to see if barefoot walking is an effective conservative management approach for plantar fasciopathy.
Participants will:
- Be randomly assigned to either a barefoot walking programme or a stretching and strengthening programme
- Complete a 12-week home-based exercise programme
- Complete short weekly questionnaires throughout the 12 weeks
- Complete 3 follow-up surveys over 6 months after the intervention ends
- Receive education on load management and plantar fasciopathy
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
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the interventions (home-based exercise programmes), blinding of participants and the care provider was not feasible. The investigator analysing the outcome data will be blinded to group allocation during data analysis.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-70 years;
- •Clinical diagnosis of Plantar Fasciopahty, defined by: a) Pain localised to the medial calcaneal tubercle of sharp or stabbing quality; b) Pain worst with the first few steps in the morning or after a period of rest (first-step pain); c) Pain reproduced with palpation of the medial calcaneal tubercle OR positive Windlass Test;
- •Symptom duration greater than 4 weeks;
- •Able to walk independently without a mobility aid
- •Able to provide informed consent and comply with study protocol
排除标准
- •Prior surgery on the affected foot
- •Diabetes with peripheral neuropathy or other neurological condition affecting lower limb sensation or motor control
- •Active inflammatory arthropathy, uncontrolled vascular disease, or inability to walk unaided
- •Current or recent (less than 6 months) bony stress fracture or other acute foot or ankle injury on the affected side
- •Pregnancy during the intervention period
- •BMI greater than 40 kg/m²
- •Corticosteroid injection to the affected foot within the previous 3 months
- •Night splints initiated less than 4 weeks prior to enrolment
- •Any condition that would make participation unsafe, including open foot wounds
研究组 & 干预措施
Barefoot Walking
Participants allocated to this arm will follow a structured 12-week progressive barefoot walking programme on grass completed at home. The programme involves gradually increasing the duration and frequency of barefoot walking on grass. Participants will receive education on plantar fasciopathy, load management principles, and guidance on how to progress the programme safely. Adherence and symptom response will be monitored through weekly short questionnaires.
干预措施: Barefoot Walking Programme (Behavioral)
Standardised Conservative Care
Participants allocated to this arm will follow a structured 12-week standardised stretching and strengthening programme completed at home. The programme includes plantar fascia and calf stretching exercises alongside progressive foot and lower limb strengthening exercises. Participants will receive education on plantar fasciopathy and load management principles. Adherence and symptom response will be monitored through weekly short questionnaires.
干预措施: Standardised Conservative Care (Behavioral)
结局指标
主要结局
First-Step Pain
时间窗: From the baseline assessment (Week 0) until end of intervention (Week 12)
Changes in average first-step morning pain over the last 7 days measured with the Numeric Pain Rating Scale (NPRS), where 0 = no pain and 10 = worst imaginable pain.
次要结局
- Adherence(Weekly during the 12-week intervention period.)
- Cost-Effectiveness (Incremental Cost-Effectiveness Ratio)(At week 12 and at 6 months post-intervention (week 36).)
- Adverse Events(Throughout the 12-week intervention and at 2, 4, and 6 months post-intervention.)
- Function(From baseline (Week 0) until the end of intervention (Week 12))
研究者
Elisabetta Brigo
PhD Student
South East Technological University