NCT06697834

Assessment of Pain in Plantar Fasciitis Managed by Histotripsy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Ramsay Générale de Santé · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fasciitis, Plantar
• Aponeurosis Contusion

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2023-12-06
• Primary completion: 2024-05-06
• Completion: 2024-09-06
• First posted: 2024-11-20
• Last updated: 2024-11-20

Locations

1 site across 1 country: France