The Efficacy of Brisement Compared to Physical Therapy for the Treatment of Achilles Tendinosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03363789|
Recruitment Status : Not yet recruiting
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Achilles Tendinopathy||Biological: Brisement injection Procedure: Physical Therapy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized Control Trial|
|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.|
|Official Title:||A Prospective Clinical Trial Comparing the Efficacy of Brisement to Physical Therapy for the Treatment of Achilles Tendinosis|
|Estimated Study Start Date :||February 2018|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Brisement
Patients will receive a series of brisement injections for treatment of non insertional Achilles tendinosis.
Biological: Brisement injection
An injection of Lidocaine into the tendon sheath to break up adhesions that could be causing the condition.
Active Comparator: Physical Therapy
Patients will undergo physical therapy for treatment of non insertional Achilles tendinosis.
Procedure: Physical Therapy
Patients will receive a prescription for physical therapy.
- VISA - A [ Time Frame: 3 months ]
- PROMIS [ Time Frame: 6 weeks, 3 months, 6 months, 1 year ]
- VAS Pain Scale [ Time Frame: Weekly for 3 months, 6 months, 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363789
|Contact: Christopher Chiodo, MDfirstname.lastname@example.org|
|Contact: Cornelia Keyser, BAemail@example.com|
|United States, Massachusetts|
|Brigham and Women's Hospital||Not yet recruiting|
|Boston, Massachusetts, United States, 02130|
|Contact: Chistopher P Chiodo, MD 617-983-7202|
|Contact: Cornelia Keyser, BA 6179837184 firstname.lastname@example.org|
|Principal Investigator:||Christopher Chiodo, MD||Brigham and Women's Hospital|