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COMPLETED
NCT06697834
NA

Assessment of Pain in Plantar Fasciitis Managed by Histotripsy

Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

31

Start Date

2023-12-06

Completion Date

2024-09-06

Last Updated

2026-07-16

Healthy Volunteers

No

Interventions

PROCEDURE

Histotripsy ultrasound session

The study will be performed with the MINDRAY DP-10 ultrasound device equipped with a linear probe and histotripsy functionality.

OTHER

VAS questionnaire

Pain assessment with the EVA questionnaire

OTHER

AOFAS questionnaire

AOFAS questionnaire at visit 1 and visit 4 (75 days after the first visit).

Locations (1)

Clinique de Domont

Domont, France