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Assessment of Pain in Plantar Fasciitis Managed by Histotripsy

NCT06697834 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2024-11-20

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • GCS Ramsay Santé pour l'Enseignement et la Recherche

    collaborator OTHER

  • Ramsay Générale de Santé

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-06
Primary Completion
2024-05-06
Completion
2024-09-06

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06697834 on ClinicalTrials.gov