The Efficacy of Brisement Compared to Physical Therapy for the Treatment of Achilles Tendinosis

Phase 4

Withdrawn

• Conditions: Achilles Tendinopathy
• Interventions: Biological: Brisement injection; Procedure: Physical Therapy

• Registration Number: NCT03363789
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-30
• Study First Submitted QC: 2017-12-01
• Study First Posted: 2017-12-06
• Study Start: 2018-02-01
• Status Verified: 2019-07
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-02
• Last Update Submitted: 2019-07-16
• Last Update Posted: 2019-07-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brisement	Brisement injection	Patients will receive a series of brisement injections for treatment of non insertional Achilles tendinosis.
Physical Therapy	Physical Therapy	Patients will undergo physical therapy for treatment of non insertional Achilles tendinosis.

Primary Outcome Measures

Name	Time	Method
VISA - A	3 months

Secondary Outcome Measures

Name	Time	Method
PROMIS	6 weeks, 3 months, 6 months, 1 year
VAS Pain Scale	Weekly for 3 months, 6 months, 1 year

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States