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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2019-07-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Achilles Tendinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Control Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The outcomes assessor will analyze the data as group 1 and 2, not knowing which group received what treatment.

Study Groups

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Brisement

Patients will receive a series of brisement injections for treatment of non insertional Achilles tendinosis.

Group Type ACTIVE_COMPARATOR

Brisement injection

Intervention Type BIOLOGICAL

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

Physical Therapy

Patients will undergo physical therapy for treatment of non insertional Achilles tendinosis.

Group Type ACTIVE_COMPARATOR

Physical Therapy

Intervention Type PROCEDURE

Patients will receive a prescription for physical therapy.

Interventions

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Brisement injection

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

Intervention Type BIOLOGICAL

Physical Therapy

Patients will receive a prescription for physical therapy.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No