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

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ClinicalTrials.gov Identifier: NCT03363789
Recruitment Status : Not yet recruiting
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
Christopher Chiodo, Brigham and Women's Hospital

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.


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
Allocation: Randomized
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.
Primary Purpose: 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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. VISA - A [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. PROMIS [ Time Frame: 6 weeks, 3 months, 6 months, 1 year ]
  2. VAS Pain Scale [ Time Frame: Weekly for 3 months, 6 months, 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Christopher Chiodo, MD 6179837202 cchiodo@partners.org
Contact: Cornelia Keyser, BA 6179837184 ckeyser@partners.org

Locations
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    ckeyser@parnters.org   
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Christopher Chiodo, MD Brigham and Women's Hospital

Responsible Party: Christopher Chiodo, Division Chief, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03363789     History of Changes
Other Study ID Numbers: 2017P002307
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be available to other researchers.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries