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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

November 30, 2017
December 6, 2017
December 6, 2017
February 2018
August 2018   (Final data collection date for primary outcome measure)
VISA - A [ Time Frame: 3 months ]
Same as current
No Changes Posted
  • PROMIS [ Time Frame: 6 weeks, 3 months, 6 months, 1 year ]
  • VAS Pain Scale [ Time Frame: Weekly for 3 months, 6 months, 1 year ]
Same as current
Not Provided
Not Provided
 
The Efficacy of Brisement Compared to Physical Therapy for the Treatment of Achilles Tendinosis
A Prospective Clinical Trial Comparing the Efficacy of Brisement to Physical Therapy for the Treatment of Achilles Tendinosis

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.

Not Provided
Interventional
Phase 4
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
Achilles Tendinopathy
  • Biological: Brisement injection
    An injection of Lidocaine into the tendon sheath to break up adhesions that could be causing the condition.
  • Procedure: Physical Therapy
    Patients will receive a prescription for physical therapy.
  • Active Comparator: Brisement
    Patients will receive a series of brisement injections for treatment of non insertional Achilles tendinosis.
    Intervention: Biological: Brisement injection
  • Active Comparator: Physical Therapy
    Patients will undergo physical therapy for treatment of non insertional Achilles tendinosis.
    Intervention: Procedure: Physical Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
Same as current
December 2018
August 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Christopher Chiodo, MD 6179837202 cchiodo@partners.org
Contact: Cornelia Keyser, BA 6179837184 ckeyser@partners.org
United States
 
 
NCT03363789
2017P002307
Yes
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
Plan to Share IPD: No
Plan Description: IPD will not be available to other researchers.
Christopher Chiodo, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Principal Investigator: Christopher Chiodo, MD Brigham and Women's Hospital
Brigham and Women's Hospital
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP