Chronic Refractory Plantar Fasciopathy
Conditions
Keywords
Plantar Fasciopathy, Plantar Fasciitis, Manual Therapy, Percutaneous Neuromodulation, Endoscopic Plantar Fasciotomy, Foot Function Index, Heel Pain, Conservative Treatment, Rehabilitation, Comparative Effectiveness
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREMultimodal 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.
PROCEDUREEndoscopic Plantar Fascial Release
Endoscopic plantar fascial release performed using a standardized surgical technique followed by a standardized postoperative rehabilitation program.
Sponsors
Universidad Europea de Valencia
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will be independent physiotherapists blinded to treatment allocation. Due to the nature of the interventions, participants and treating clinicians cannot be blinded.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Foot Function Index (FFI) total score | Baseline and 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity measured by the Visual Analog Scale (VAS) | Baseline, 3 weeks, 6 weeks, and 12 weeks | Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS). |
| Change in health-related quality of life assessed by the EQ-5D-5L | Baseline, 6 weeks, and 12 weeks | Health-related quality of life will be evaluated using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). |
| Treatment adherence | During the 6-week intervention period | Treatment adherence will be assessed as the proportion of scheduled sessions attended by participants. |
| Incidence of adverse events | From baseline through 12 weeks | Adverse events will be recorded and classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
Countries
Spain
Contacts
CONTACTJavier Bonastre Férez, PhD
Outcome results
None listed