Multimodal Conservative Intervention Versus Surgery for Chronic Refractory Plantar Fasciopathy

June 12, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Active Comparator: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Foot Function Index (FFI) total score
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain intensity measured by the Visual Analog Scale (VAS)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tibial nerve sensory conduction velocity assessed by electromyography
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Europea de Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

June 12, 2026

First Submitted That Met QC Criteria

June 12, 2026

First Posted (Actual)

June 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 12, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UEV-PF-MTPNM-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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