Multimodal Conservative Intervention Versus Surgery for Chronic Refractory Plantar Fasciopathy

ConditionChronic Refractory Plantar Fasciopathy

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age30-65

SponsorUniversidad Europea de Valencia

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Multimodal Conservative Intervention
Procedure/Surgery
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/Surgery
Endoscopic plantar fascial release performed using a standardized surgical technique followed by a standardized postoperative rehabilitation program.

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: Multimodal Conservative InterventionExperimental treatment 1 intervention

Group B: Surgical ManagementActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Baseline and 6 weeks

Secondary outcomes

Change in pain intensity measured by the Visual Analog Scale (VAS)

Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS).

Time frame

Baseline, 3 weeks, 6 weeks, and 12 weeks

Change in health-related quality of life assessed by the EQ-5D-5L

Health-related quality of life will be evaluated using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L).

Time frame

Baseline, 6 weeks, and 12 weeks

Treatment adherence

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

Time frame

During the 6-week intervention period

Incidence of adverse events

Adverse events will be recorded and classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Time frame

From baseline through 12 weeks

Other outcomes

Tibial nerve sensory conduction velocity assessed by electromyography

Exploratory neurophysiological assessment of tibial nerve sensory conduction velocity measured by electromyography to investigate potential changes associated with the interventions.

Time frame

Baseline and 12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad Europea de Valencia

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: