Multimodal Conservative Intervention Versus Surgery for Chronic Refractory Plantar Fasciopathy
Study Protocol for a Multicenter Controlled Trial Comparing Multimodal Conservative Intervention Versus Surgical Management in Chronic Refractory Plantar Fasciopathy
Chronic refractory plantar fasciopathy is a common musculoskeletal condition that can cause persistent heel pain and functional limitations despite conservative treatment. When symptoms do not improve, patients often face the decision between continuing non-surgical management or undergoing surgery. However, direct comparative evidence between these treatment strategies is limited.
This multicenter controlled trial aims to compare the effectiveness of a multimodal conservative intervention consisting of manual therapy and ultrasound-guided percutaneous neuromodulation with endoscopic plantar fascial release followed by standard postoperative rehabilitation in adults with chronic refractory plantar fasciopathy.
A total of 120 participants will be allocated to treatment groups according to their informed treatment preference within a shared decision-making process. The primary outcome will be the change in the Foot Function Index (FFI) after 6 weeks. Secondary outcomes include pain intensity, health-related quality of life, treatment adherence, adverse events, and exploratory neurophysiological measures. The results are expected to provide evidence to support clinical decision-making and optimize the management of patients with chronic refractory plantar fasciopathy.
研究概览
地位
详细说明
Chronic refractory plantar fasciopathy is one of the most common causes of persistent heel pain and is associated with substantial disability, reduced quality of life, and limitations in daily and occupational activities. Although most patients respond to conservative management, a subgroup continues to experience symptoms despite prolonged treatment and may be considered for surgical intervention. However, evidence directly comparing optimized multimodal conservative care with surgical management remains limited.
This multicenter, non-randomized controlled trial has been designed to evaluate the comparative effectiveness of these two therapeutic strategies under real-world clinical conditions. Participants will be allocated to treatment groups according to their informed treatment preference following a standardized shared decision-making process.
The experimental group will receive a 6-week multimodal conservative intervention consisting of manual therapy techniques and ultrasound-guided percutaneous neuromodulation delivered in 12 supervised sessions. The control group will undergo endoscopic plantar fascial release followed by a standardized postoperative rehabilitation program.
The primary outcome measure is the change in the Foot Function Index (FFI) at 6 weeks after treatment initiation. Secondary outcomes include pain intensity measured using the Visual Analog Scale (VAS), health-related quality of life assessed with the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L), treatment adherence, adverse events, and exploratory neurophysiological assessment through electromyography.
To minimize the effects of treatment selection bias inherent to the non-randomized design, analyses will include adjusted analysis of covariance (ANCOVA) and inverse probability of treatment weighting (IPTW). The findings of this study are expected to provide clinically relevant evidence to support shared decision-making and optimize treatment selection for patients with chronic refractory plantar fasciopathy.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Javier Bonastre Férez, PhD
- 电话号码：+34644120315
- 邮箱：javier.bonastre@universidadeuropea.es
学习地点
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Valencia
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Valencia、Valencia、西班牙、46010
- European University of Valencia
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接触：
- Javier Bonastre Férez, PhD
- 电话号码：+34644120315
- 邮箱：javier.bonastre@universidadeuropea.es
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Adults aged 30 to 65 years.
- Diagnosis of chronic refractory plantar fasciopathy with symptom duration greater than 6 months.
- Failure of at least two previous conservative treatments, each lasting at least 12 weeks.
- Foot Function Index (FFI) total score ≥45 points.
- Resting pain intensity ≥4/10 on the Visual Analog Scale (VAS).
- Plantar fascia thickness ≥4 mm at the calcaneal insertion confirmed by ultrasound.
- Ability to provide written informed consent and comply with study procedures.
Exclusion Criteria:
- Previous foot surgery on the affected side.
- Calcaneal stress fracture.
- Glycated hemoglobin (HbA1c) >7.5%.
- Inability or unwillingness to comply with study procedures or follow-up assessments.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Multimodal Conservative Intervention
Participants assigned to this arm will receive a 6-week multimodal conservative intervention consisting of manual therapy techniques combined with ultrasound-guided percutaneous neuromodulation, delivered in 12 supervised sessions (2 sessions per week).
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A 6-week multimodal conservative treatment including manual therapy techniques (gastrocnemius stretching, transverse friction massage, and tibial nerve neurodynamic mobilization) combined with ultrasound-guided percutaneous neuromodulation of the posterior tibial nerve using low-frequency electrical stimulation.
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有源比较器：Surgical Management
Participants assigned to this arm will undergo endoscopic plantar fascial release followed by a standardized postoperative rehabilitation program, including manual therapy during the rehabilitation period.
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Endoscopic plantar fascial release performed using a standardized surgical technique followed by a standardized postoperative rehabilitation program.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Foot Function Index (FFI) total score
大体时间：Baseline and 6 weeks
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The primary outcome is the change in the total Foot Function Index (FFI) score from baseline to 6 weeks after treatment initiation.
The FFI is a validated patient-reported outcome measure assessing pain and functional disability related to foot disorders.
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Baseline and 6 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in pain intensity measured by the Visual Analog Scale (VAS)
大体时间：Baseline, 3 weeks, 6 weeks, and 12 weeks
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Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS).
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Baseline, 3 weeks, 6 weeks, and 12 weeks
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Change in health-related quality of life assessed by the EQ-5D-5L
大体时间：Baseline, 6 weeks, and 12 weeks
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Health-related quality of life will be evaluated using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L).
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Baseline, 6 weeks, and 12 weeks
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Treatment adherence
大体时间：During the 6-week intervention period
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Treatment adherence will be assessed as the proportion of scheduled sessions attended by participants.
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During the 6-week intervention period
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Incidence of adverse events
大体时间：From baseline through 12 weeks
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Adverse events will be recorded and classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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From baseline through 12 weeks
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Tibial nerve sensory conduction velocity assessed by electromyography
大体时间：Baseline and 12 weeks
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Exploratory neurophysiological assessment of tibial nerve sensory conduction velocity measured by electromyography to investigate potential changes associated with the interventions.
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Baseline and 12 weeks
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合作者和调查者
出版物和有用的链接
一般刊物
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研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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其他研究编号
- UEV-PF-MTPNM-2026-01
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