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

Study Overview
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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.

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

Conditions
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Achilles Tendinopathy

Intervention / Treatment
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* Biological: Brisement injection
* Procedure: Physical Therapy


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Control Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brisement<br>Patients will receive a series of brisement injections for treatment of non insertional Achilles tendinosis. | Biological: Brisement injection<br>* An injection of Lidocaine into the tendon sheath to break up adhesions that could be causing the condition.<br>|
| Active Comparator: Physical Therapy<br>Patients will undergo physical therapy for treatment of non insertional Achilles tendinosis. | Procedure: Physical Therapy<br>* Patients will receive a prescription for physical therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VISA - A |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS |  | 6 weeks, 3 months, 6 months, 1 year | 
| VAS Pain Scale |  | Weekly for 3 months, 6 months, 1 year |