CompletedNot Applicable

Assessment of Pain in Plantar Fasciitis Managed by Histotripsy

France31 participantsStarted 2023-12-06

Plain-language summary

Plantar fasciitis or plantar fasciitis is the most commonly reported cause of pain under the heel. Its prevalence varies from 3.6 to 7% in the general population. It is a painful condition of the foot that corresponds to an inflammation of the plantar fascia. At present, histotripsy in the field of orthopedics is very little used. The concept of therapeutic ultrasound intended for the treatment of plantar fasciitis by fascial section was developed in the United States but no study evaluating its effects on pain is available. There is no equivalent study on histotripsy in the pathology of chronic plantar fasciitis or fasciitis. In this study, histotripsy will be performed using a conventional serial ultrasound system with this focused energy function. The research hypothesis is that histotripsy treatment may be an alternative to pain management in patients with plantar fasciitis who have failed conventional treatments. The main objective of this study is to evaluate the evolution of the pain felt by patients with plantar fasciitis resistant to conventional medical treatment, one month after two ultrasound histotripsy sessions.

Who can participate

Age range

18 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: * Patient, male or female, aged 18 years minimum * Patient with plantar fasciitis evolving for at least 6 months * Patients with radiology and MRI of the foot less than 3 months old * Visual analogue pain scale greater than 5 at inclusion * Patient in whom conventional medical treatment has failed by the combination of radial shock waves, plantar orthoses, and corticosteroid infiltration that has not provided relief. * Patient affiliated with or beneficiary of a social security scheme. * Patient who has been informed and has given his/her free, informed and written consent. Exclusion Criteria: * Minor patient * Major retraction of the triceps surae on the MAESTRO oblique board test: sequelae of bone trauma to the hindfoot and ankle. * Inflammatory rheumatological diseases * Fibromyalgia * Patients in whom a specific underlying organic pathology (inflammatory, infectious, neoplastic, etc.) has been identified. * Psychiatric disorders * Patient participating in another research study. * Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision * Pregnant, breastfeeding or parturient woman. * Patient hospitalized without consent.

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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.

What they're measuring

the percentage of change in pain (VAS 0-10)

Timeframe: 1 month and a half

Trial details

NCT IDNCT06697834

SponsorRamsay Générale de Santé

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-06

View on ClinicalTrials.gov More Fasciitis, Plantar trials