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

Achilles Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03363789
• Other study ID #: 2017P002307
• Status: Withdrawn
• Phase: Phase 4
• Start date: February 1, 2018
• Est. completion date: July 2, 2019

Study information

• Verified date: July 2019
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Achilles Tendinopathy
• Tendinopathy

Intervention

Biological:
• Brisement injection
An injection of Lidocaine into the tendon sheath to break up adhesions that could be causing the condition.

Procedure:
• Physical Therapy
Patients will receive a prescription for physical therapy.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VISA - A		3 months
Secondary	PROMIS		6 weeks, 3 months, 6 months, 1 year
Secondary	VAS Pain Scale		Weekly for 3 months, 6 months, 1 year