Multimodal Conservative Intervention Versus Surgery for Chronic Refractory Plantar Fasciopathy

NCT07654660 | Not Yet Recruiting

• 1 other identifier: UEV-PF-MTPNM-2026-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Refractory Plantar Fasciopathy

Keywords

Plantar Fasciopathy; Plantar Fasciitis; Manual Therapy; Percutaneous Neuromodulation; Endoscopic Plantar Fasciotomy; Foot Function Index; Heel Pain; Conservative Treatment; Rehabilitation; Comparative Effectiveness

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Change in pain intensity measured by the 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

  Baseline, 6 weeks, and 12 weeks

• Treatment adherence

  During the 6-week intervention period

• Incidence of adverse events

  From baseline through 12 weeks

Other Outcomes (1)

• Tibial nerve sensory conduction velocity assessed by electromyography

  Baseline and 12 weeks

Study Arms (2)

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).

Procedure: Multimodal Conservative Intervention

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.

Procedure: Endoscopic Plantar Fascial Release

Interventions

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.

Multimodal Conservative Intervention

Endoscopic Plantar Fascial Release PROCEDURE

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

Surgical Management

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Europea de Valencia: lead

Study Sites (1)

European University of Valencia

Valencia, Valencia, 46010, Spain

Location

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MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Central Study Contacts

Javier Bonastre Férez, PhD

CONTACT

+34644120315; javier.bonastre@universidadeuropea.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be independent physiotherapists blinded to treatment allocation. Due to the nature of the interventions, participants and treating clinicians cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physiotherapy

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

ES (1)