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Clinical Trials in Spain / NCT07654660
Starting soon Not applicable

Multimodal Conservative Intervention Versus Surgery for Chronic Refractory Plantar Fasciopathy

NCT07654660 · tracked via the Priya Life Science Spain tracker
Sponsor
Universidad Europea de Valencia
Phase
Not applicable
Started
2026-12
Last updated
2026-06-17

Condition(s) studied

Chronic Refractory Plantar Fasciopathy

Investigational drug(s) / intervention(s)

Multimodal Conservative InterventionEndoscopic Plantar Fascial Release

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.

Endoscopic Plantar Fascial Release: Endoscopic plantar fascial release performed using a standardized surgical technique followed by a standardized postoperative rehabilitation program.

Study 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.

Eligibility

Sex
ALL
Min age
30 Years
Max age
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.

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
European University of Valencia Valencia Valencia

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07654660 on ClinicalTrials.gov ↗ ← All trials in Spain