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

Mass General Brigham logo

Mass General Brigham

Status and phase

Withdrawn
Phase 4

Conditions

Achilles Tendinopathy

Treatments

Biological: Brisement injection
Procedure: Physical Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03363789
2017P002307

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups

Brisement
Active Comparator group
Description:
Patients will receive a series of brisement injections for treatment of non insertional Achilles tendinosis.
Treatment:
Biological: Brisement injection
Physical Therapy
Active Comparator group
Description:
Patients will undergo physical therapy for treatment of non insertional Achilles tendinosis.
Treatment:
Procedure: Physical Therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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