A Prospective Clinical Trial Comparing the Efficacy of Brisement to Physical Therapy for the Treatment of Achilles Tendinosis
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Brigham and Women's Hospital
- Locations
- 2
- Primary Endpoint
- VISA - A
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The outcomes assessor will analyze the data as group 1 and 2, not knowing which group received what treatment.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Brisement
Patients will receive a series of brisement injections for treatment of non insertional Achilles tendinosis.
Intervention: Brisement injection (Biological)
Physical Therapy
Patients will undergo physical therapy for treatment of non insertional Achilles tendinosis.
Intervention: Physical Therapy (Procedure)
Outcomes
Primary Outcomes
VISA - A
Time Frame: 3 months
Secondary Outcomes
- PROMIS(6 weeks, 3 months, 6 months, 1 year)
- VAS Pain Scale(Weekly for 3 months, 6 months, 1 year)
Investigators
Christopher Chiodo
Division Chief
Brigham and Women's Hospital