Multimodal Conservative Intervention Versus Surgery for Chronic Refractory Plantar Fasciopathy (NCT07654660) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Multimodal Conservative Intervention Versus Surgery for Chronic Refractory Plantar Fasciopathy
Spain120 participantsStarted 2026-12
Plain-language summary
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.
Who can participate
Age range
30 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares a multimodal conservative treatment to surgery for chronic refractory plantar fasciopathy — since it hasn't started recruiting yet, can you tell me roughly when it might open and whether it would still be worth waiting for, or if I should consider starting a treatment path now?
2The trial is measuring improvement using the Foot Function Index score — can you explain what that tool actually measures and whether my current level of foot pain and disability would likely show meaningful change on that scale?
3Since my plantar fasciopathy is described as 'chronic and refractory,' can you walk me through what treatments I would typically need to have already tried and failed before I might even be considered for a study like this?
4This trial is comparing conservative care to surgery — given where I am in my treatment journey, do you think surgery is something I should genuinely be weighing right now, or are there conservative options I haven't fully exhausted yet?
5Because this trial is listed as 'Phase NA' and hasn't started recruiting, how confident are you in the safety profile of either the surgical or conservative arm being studied, and what should I know about the risks of each approach before considering participation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.