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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal Conservative Intervention | Experimental | 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). |
|
| Surgical Management | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal Conservative Intervention | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Foot Function Index (FFI) total score | 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. | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain intensity measured by the Visual Analog Scale (VAS) | Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS). | Baseline, 3 weeks, 6 weeks, and 12 weeks |
| Change in health-related quality of life assessed by the EQ-5D-5L |
| Measure | Description | Time Frame |
|---|---|---|
| Tibial nerve sensory conduction velocity assessed by electromyography | Exploratory neurophysiological assessment of tibial nerve sensory conduction velocity measured by electromyography to investigate potential changes associated with the interventions. | Baseline and 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Javier Bonastre Férez, PhD | Contact | +34644120315 | javier.bonastre@universidadeuropea.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European University of Valencia | Valencia | Valencia | 46010 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25956159 | Background | Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015 May 8;350:h2147. doi: 10.1136/bmj.h2147. No abstract available. | |
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At the time of study registration, no final decision has been made regarding the sharing of individual participant data (IPD). Any future data sharing will be considered in accordance with institutional policies, ethical approvals, participant consent, and applicable data protection regulations. If data sharing is approved, only de-identified data will be made available.
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| ID | Term |
|---|---|
| D036981 | Fasciitis, Plantar |
| ID | Term |
|---|---|
| D005208 | Fasciitis |
| D009140 | Musculoskeletal Diseases |
| D005534 | Foot Diseases |
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Participants will be assigned to one of two parallel intervention groups according to their informed treatment preference following a standardized shared decision-making process. One group will receive a multimodal conservative intervention consisting of manual therapy and ultrasound-guided percutaneous neuromodulation, while the other group will undergo endoscopic plantar fascial release followed by standardized postoperative rehabilitation.
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Outcome assessors will be independent physiotherapists blinded to treatment allocation. Due to the nature of the interventions, participants and treating clinicians cannot be blinded.
|
| Endoscopic Plantar Fascial Release | Procedure | Endoscopic plantar fascial release performed using a standardized surgical technique followed by a standardized postoperative rehabilitation program. |
|
Health-related quality of life will be evaluated using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L).
| Baseline, 6 weeks, and 12 weeks |
| Treatment adherence | Treatment adherence will be assessed as the proportion of scheduled sessions attended by participants. | During the 6-week intervention period |
| Incidence of adverse events | Adverse events will be recorded and classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | From baseline through 12 weeks |
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