European University of Valencia
Valencia, 46010, Spain
NCT Number: NCT07654660
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.
Trial opening soon.
Get Notified30 year–65 year
All sexes
Interventional
Not applicable
Valencia, 46010, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 performed using a standardized surgical technique followed by a standardized postoperative rehabilitation program.
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.
Time frame: Baseline, 3 weeks, 6 weeks, and 12 weeks
Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS).
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).
Time frame: During the 6-week intervention period
Treatment adherence will be assessed as the proportion of scheduled sessions attended by participants.
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.
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.
Contact information is provided by the study sponsor or research team.
Universidad Europea de Valencia
Other
Study Protocol for a Multicenter Controlled Trial Comparing Multimodal Conservative Intervention Versus Surgical Management in Chronic Refractory Plantar Fasciopathy
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.
Published trials that share one or more normalized conditions with this study.
NCT07703111
Fasciitis, Fasciitis, Plantar
Lahore, Punjab Province, Pakistan
View Trial DetailsNCT07657533
Fasciitis, Fasciitis, Plantar
Al Kharj, Saudi Arabia
View Trial DetailsNCT07626723
Extracorporeal Shock Wave Therapy, Fasciitis
Kırşehir, Turkey (Türkiye)
View Trial DetailsNCT07587255
Fasciitis, Fasciitis, Plantar
View Trial Details