The Efficacy of Brisement Compared to Physical Therapy fo... | NCT03363789

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

NCT03363789

Sponsor

Brigham and Women's Hospital

Status

Withdrawn

Last Update Posted

Jul 18, 2019Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Achilles Tendinopathy

Interventions

Brisement injection
Physical Therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient recruitment

Expanded Access Info

Start Date

Feb 1, 2018Actual

Primary Completion Date

Jul 1, 2019Actual

Completion Date

Jul 2, 2019Actual

First Submitted Date

Nov 30, 2017

First Submission Date that Met QC Criteria

Dec 1, 2017

First Posted Date

Dec 6, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2019

Last Update Posted Date

Jul 18, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Brisement injection	Biological	An injection of Lidocaine into the tendon sheath to break up adhesions that could be causing the condition.	Brisement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VISA - A		3 months

Secondary Outcomes

Measure	Description	Time Frame
PROMIS		6 weeks, 3 months, 6 months, 1 year
VAS Pain Scale		Weekly for 3 months, 6 months, 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher Chiodo, MD	Brigham and Women's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brigham and Women's Hospital		Boston	Massachusetts	02130	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

IPD will not be available to other researchers.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D026741	Physical Therapy Modalities

Ancestor Terms

ID	Term
D013812	Therapeutics
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided