Astym® Compared Eccentric Exercise for Chronic Mid-substance Achilles Tendinopathy
Primary Purpose
Achilles Tendon Pain
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Astym
Sponsored by
About this trial
This is an interventional treatment trial for Achilles Tendon Pain
Eligibility Criteria
Inclusion Criteria
- Pain for 3 months or longer in the mid portion of only one Achilles tendon.
- Must read, speak and understand English
Exclusion Criteria
- Previous surgery to the Achilles tendon that is currently painful
- An injection into the Achilles tendon in the previous 4 weeks
- Have symptoms in both Achilles tendons concurrently
- Have taken fluoroquinolone antibiotics in the past 6 months
Sites / Locations
- IU Health
- Utah Physical Therapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Astym
Eccentric Exercise
Arm Description
A form of soft tissue mobilization using instruments
Eccentric exercise is a form of exercise where the benefit comes from applying a controlled lengthening stress to the muscle and tendon.
Outcomes
Primary Outcome Measures
VISA-A
Secondary Outcome Measures
Numeric Pain Rating Scale
Full Information
NCT ID
NCT01902433
First Posted
July 15, 2013
Last Updated
January 21, 2017
Sponsor
Emily Slaven, PT, PhD
Collaborators
Performance Dynamics
1. Study Identification
Unique Protocol Identification Number
NCT01902433
Brief Title
Astym® Compared Eccentric Exercise for Chronic Mid-substance Achilles Tendinopathy
Official Title
Astym® Treatment Compared With Eccentric Exercise in the Management of Chronic Mid-substance Achilles Tendinopathy: A Multisite a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
We were unable to recruit participants to the study
Study Start Date
August 2013 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emily Slaven, PT, PhD
Collaborators
Performance Dynamics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the changes in pain and self-perceived function between two different treatments for Achilles tendinopathy: the Astym® protocol (a form of soft tissue mobilization using instruments) and a specific exercise protocol that involves strengthening the calf and Achilles tendon. Astym® (A-stim) is not an acronym, but rather stands for "A Stimulation" of the body's healing response, describing the physiologic process which occurs with Astym treatment. Astym is the trademark name of a non-invasive treatment where instruments are applied topically to locate unhealthy soft tissue, and to transfer mild to moderate pressure to the underlying soft tissue structures. The aim of Astym treatment is to eliminate scar tissue and stimulate tissue regeneration. Both the principal investigator and co-investigator have been trained and certified in administering the Astym treatment. The specific exercise protocol will involve exercises that strengthen the Achilles and calf through eccentric exercise. Eccentric exercise is a form of exercise where the benefit comes from applying a controlled lengthening stress to the muscle and tendon.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendon Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Astym
Arm Type
Experimental
Arm Description
A form of soft tissue mobilization using instruments
Arm Title
Eccentric Exercise
Arm Type
Active Comparator
Arm Description
Eccentric exercise is a form of exercise where the benefit comes from applying a controlled lengthening stress to the muscle and tendon.
Intervention Type
Procedure
Intervention Name(s)
Astym
Primary Outcome Measure Information:
Title
VISA-A
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Pain for 3 months or longer in the mid portion of only one Achilles tendon.
Must read, speak and understand English
Exclusion Criteria
Previous surgery to the Achilles tendon that is currently painful
An injection into the Achilles tendon in the previous 4 weeks
Have symptoms in both Achilles tendons concurrently
Have taken fluoroquinolone antibiotics in the past 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily J Slaven, PhD
Organizational Affiliation
University of Indianapolis
Official's Role
Principal Investigator
Facility Information:
Facility Name
IU Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
Facility Name
Utah Physical Therapy
City
Lehi
State/Province
Utah
ZIP/Postal Code
84043
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Only two participants were recruited to the study at the closure of the study
Learn more about this trial
Astym® Compared Eccentric Exercise for Chronic Mid-substance Achilles Tendinopathy
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