A Prospective Clinical Trial Comparing the Efficacy of Brisement to Physical Therapy for the Treatment of Achilles Tendinosis

Brigham and Women's Hospital1 site in 1 countryFebruary 1, 2018

ConditionsAchilles Tendinopathy

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Achilles Tendinopathy
Sponsor: Brigham and Women's Hospital
Locations: 1
Primary Endpoint: VISA - A
Status: Withdrawn
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare the effectiveness of ultrasound guided brisement, brisement without ultrasound guidance and standard conservative treatment in patients who have been diagnosed with Achilles tendinosis. We are asking you to take part in this research study because you are a patient of the Brigham Foot and Ankle Clinic who has been diagnosed with Achilles tendinosis. About 100 people will take part in this research study, all at Brigham and Women's Hospital (BWH).

To our knowledge, there has been very little research in the efficacy of the addition of briesment injections to standard, conservative treatment of Achilles tendinosis. We hope our results will show which method is the most effective conservative treatment for Achilles tendinosis. This information will help doctors make decisions in the future.

Registry

clinicaltrials.gov

Start Date

February 1, 2018

End Date

July 2, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Brigham and Women's Hospital

Responsible Party

Principal Investigator

Christopher Chiodo

Division Chief

Brigham and Women's Hospital

Eligibility Criteria

Inclusion Criteria

•All patients enrolled in the study must have a diagnosis of Achilles tendinosis with at least 2 weeks of pain at the distal Achilles tendon which is typically worsened with activity. Only cases of non-insertional Achilles tendinosis (tendinosis occurring above the point of tendon insertion) will be included.

Exclusion Criteria

•Patients with a prior Achilles tendon tear, chronic inflammatory disease, or history of posterior calf surgery will be excluded from the study. Additionally, patients with prior injuries or fractures to the ankle and hind foot (talus and calcaneus) requiring surgery will be excluded.