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NCT Number: NCT07654660

Multimodal Conservative Intervention Versus Surgery for 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.

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Endoscopic Plantar Fascial Release

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. Treatment adherence

    Time frame: During the 6-week intervention period

    Treatment adherence will be assessed as the proportion of scheduled sessions attended by participants.

  4. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Javier Bonastre Férez, PhD

CONTACT

[email protected]

+34644120315

Sponsors and collaborators

Lead sponsor

Universidad Europea de Valencia

Other

Registry information

Official study title

Study Protocol for a Multicenter Controlled Trial Comparing Multimodal Conservative Intervention Versus Surgical Management in Chronic Refractory Plantar Fasciopathy

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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