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Multimodal Conservative Intervention Versus Surgery for Chronic Refractory Plantar Fasciopathy

12 juni 2026 bijgewerkt door: Dr. Javier Bonastre Férez, Universidad Europea de Valencia

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

120

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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).
Procedure: 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.
Actieve vergelijker: 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.
Procedure: Endoscopic Plantar Fascial Release
Endoscopic plantar fascial release performed using a standardized surgical technique followed by a standardized postoperative rehabilitation program.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Foot Function Index (FFI) total score
Tijdsspanne: 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.
Baseline and 6 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in pain intensity measured by the Visual Analog Scale (VAS)
Tijdsspanne: Baseline, 3 weeks, 6 weeks, and 12 weeks
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
Tijdsspanne: 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).
Baseline, 6 weeks, and 12 weeks
Treatment adherence
Tijdsspanne: During the 6-week intervention period
Treatment adherence will be assessed as the proportion of scheduled sessions attended by participants.
During the 6-week intervention period
Incidence of adverse events
Tijdsspanne: From baseline through 12 weeks
Adverse events will be recorded and classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
From baseline through 12 weeks

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Tibial nerve sensory conduction velocity assessed by electromyography
Tijdsspanne: Baseline and 12 weeks
Exploratory neurophysiological assessment of tibial nerve sensory conduction velocity measured by electromyography to investigate potential changes associated with the interventions.
Baseline and 12 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Universidad Europea de Valencia

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 december 2026

Primaire voltooiing (Geschat)

1 september 2027

Studie voltooiing (Geschat)

1 januari 2028

Studieregistratiedata

Eerst ingediend

12 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

12 juni 2026

Eerst geplaatst (Werkelijk)

17 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

12 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • UEV-PF-MTPNM-2026-01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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