Multimodal Conservative Intervention Versus Surgery for Chronic Refractory Plantar Fasciopathy
Not yet recruitingNot applicableNCT07654660
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Study Protocol for a Multicenter Controlled Trial Comparing Multimodal Conservative Intervention Versus Surgical Management in Chronic Refractory Plantar Fasciopathy
- Conditions
- Chronic Refractory Plantar Fasciopathy
- Interventions
- Procedure: Multimodal Conservative Intervention
- Procedure: Endoscopic Plantar Fascial Release
- Sponsor
- Universidad Europea de Valencia
- Start date
- 2026-12
- Primary completion
- 2027-09
- Sex
- All
- Age range
- from 30 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- Spain
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07654660