Multimodal Conservative Intervention Versus Surgery for Chronic Refractory Plantar Fasciopathy

Official title

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

Overview

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.

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.

Interventions

• 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.
• Procedure Endoscopic Plantar Fascial Release
  Endoscopic plantar fascial release performed using a standardized surgical technique followed by a standardized postoperative rehabilitation program.

Primary outcome measures

• Change in Foot Function Index (FFI) total score [Time frame: Baseline and 6 weeks]

Secondary outcome measures (4)

• Change in pain intensity measured by the 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 [Time frame: Baseline, 6 weeks, and 12 weeks]
• Treatment adherence [Time frame: During the 6-week intervention period]
• Incidence of adverse events [Time frame: From baseline through 12 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• European University of Valencia — Valencia

Publications

• Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015 May 8;350:h2147. doi: 10.1136/bmj.h2147. No abstract available. PMID 25956159
• Austin PC. The performance of different propensity-score methods for estimating differences in proportions (risk differences or absolute risk reductions) in observational studies. Stat Med. 2010 Sep 10;29(20):2137-48. doi: 10.1002/sim.3854. PMID 20108233
• Baxter DE, Thigpen CM. Heel pain--operative results. Foot Ankle. 1984 Jul-Aug;5(1):16-25. doi: 10.1177/107110078400500103. PMID 6479759
• Morrissey D, Cotchett M, Said J'Bari A, Prior T, Griffiths IB, Rathleff MS, Gulle H, Vicenzino B, Barton CJ. Management of plantar heel pain: a best practice guide informed by a systematic review, expert clinical reasoning and patient values. Br J Sports Med. 2021 Oct;55(19):1106-1118. doi: 10.1136/bjsports-2019-101970. Epub 2021 Mar 30. PMID 33785535
• Roy J. Applied Longitudinal Analysis , Second Edition, by G. M. Fitzmaurice, N. M. Laird, and J. H. Ware. J Biopharm Stat 2013; 23: 491-492.
• Steyerberg EW, Vergouwe Y. Towards better clinical prediction models: seven steps for development and an ABCD for validation. Eur Heart J. 2014 Aug 1;35(29):1925-31. doi: 10.1093/eurheartj/ehu207. Epub 2014 Jun 4. PMID 24898551
• Vickers AJ, Altman DG. Statistics notes: Analysing controlled trials with baseline and follow up measurements. BMJ. 2001 Nov 10;323(7321):1123-4. doi: 10.1136/bmj.323.7321.1123. No abstract available. PMID 11701584
• Carroll C, Patterson M, Wood S, Booth A, Rick J, Balain S. A conceptual framework for implementation fidelity. Implement Sci. 2007 Nov 30;2:40. doi: 10.1186/1748-5908-2-40. PMID 18053122

Identifiers

NCT: NCT07654660 · UEV-PF-MTPNM-2026-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗