Multimodal Conservative Intervention Versus Surgery for Chronic Refractory Plantar Fasciopathy

Официальное название

Study Protocol for a Multicenter Controlled Trial Comparing Multimodal Conservative Intervention Versus Surgical Management in Chronic Refractory Plantar Fasciopathy

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Multimodal Conservative Intervention
  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.
• Процедура Endoscopic Plantar Fascial Release
  Endoscopic plantar fascial release performed using a standardized surgical technique followed by a standardized postoperative rehabilitation program.

Первичные конечные точки

• Change in Foot Function Index (FFI) total score [Срок оценки: Baseline and 6 weeks]

Вторичные конечные точки (4)

• Change in pain intensity measured by the Visual Analog Scale (VAS) [Срок оценки: Baseline, 3 weeks, 6 weeks, and 12 weeks]
• Change in health-related quality of life assessed by the EQ-5D-5L [Срок оценки: Baseline, 6 weeks, and 12 weeks]
• Treatment adherence [Срок оценки: During the 6-week intervention period]
• Incidence of adverse events [Срок оценки: From baseline through 12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• European University of Valencia — Valencia

Публикации

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Идентификаторы

NCT: NCT07654660 · UEV-PF-MTPNM-2026-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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