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

NCT03363789 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 2017P002307
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Achilles Tendinopathy

Outcome Measures

Primary Outcomes (1)

• VISA - A

  3 months

Secondary Outcomes (2)

• PROMIS

  6 weeks, 3 months, 6 months, 1 year

• VAS Pain Scale

  Weekly for 3 months, 6 months, 1 year

Study Arms (2)

Brisement

ACTIVE COMPARATOR

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

Biological: Brisement injection

Physical Therapy

ACTIVE COMPARATOR

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

Procedure: Physical Therapy

Interventions

Brisement injection BIOLOGICAL

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

Brisement

Physical Therapy PROCEDURE

Patients will receive a prescription for physical therapy.

Physical Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Christopher Chiodo, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will analyze the data as group 1 and 2, not knowing which group received what treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 6, 2017
• Study Start: February 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 2, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)