Astym® Compared Eccentric Exercise for Chronic Mid-substance Achilles Tendinopathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Indianapolis
Sponsor:
Collaborator:
Performance Dynamics
Information provided by (Responsible Party):
Emily Slaven, PT, PhD, University of Indianapolis
ClinicalTrials.gov Identifier:
NCT01902433
First received: July 15, 2013
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Achilles Tendon Pain
Procedure: Astym

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Astym® Treatment Compared With Eccentric Exercise in the Management of Chronic Mid-substance Achilles Tendinopathy: A Multisite a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Indianapolis:

Primary Outcome Measures:
  • VISA-A [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Numeric Pain Rating Scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Astym
A form of soft tissue mobilization using instruments
Procedure: Astym
Active Comparator: Eccentric Exercise
Eccentric exercise is a form of exercise where the benefit comes from applying a controlled lengthening stress to the muscle and tendon.
Procedure: Astym

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01902433

Contacts
Contact: Emily J Slaven, PhD 317-788-3305 slavene@uindy.edu

Locations
United States, Arizona
Spooner Physical Therapy Recruiting
Scottsdale, Arizona, United States, 85260
Contact: Torrey Foster, PT    480-551-4952    t.foster@spoonerphysicaltherapy.com   
Principal Investigator: Torrey Foster, PT         
Sub-Investigator: Corrie Schofield, PT         
United States, Iowa
Stadia Sports Medicine Recruiting
West Des Moines, Iowa, United States, 50266
Contact: Detlef Maltas, PT    515-221-1102    dmaltas@stadiasportsmedicine.com   
Principal Investigator: Detlef Maltas, PT         
United States, Kansas
Preferred Physical Therapy Recruiting
Sterling, Kansas, United States, 67579
Contact: Tad Wrench, PT    620-204-6116    twrench@aptclinics.com   
Principal Investigator: Tad Wrench, PT         
United States, New York
Orthosport Recruiting
Snyder, New York, United States, 14226
Contact: Peter Young, PT    716-839-3705    phyyoung1@yahoo.com   
Principal Investigator: Peter Young, PT         
United States, Oregon
Oregon Health and Science University Recruiting
Beaverton, Oregon, United States, 97006
Contact: Valerie Priest, PT    503-418-2448    priestv@ohsu.edu   
Principal Investigator: Valerie Priest, PT         
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Lindsay Brown, PT    503-494-3151    brlindsa@ohsu.edu   
Principal Investigator: Lindsey Brown, PT         
Sub-Investigator: Chante' Larlee, PT         
United States, Tennessee
Alliance Physical Therapy Recruiting
Chattanooga, Tennessee, United States, 37404
Contact: Jeff Poteralski, PT    423-702-9984    jpoteralski@nopainpt.com   
Principal Investigator: Jeff Poteralski, PT         
United States, Utah
Mountain Land Rehabilitation Recruiting
Lehi, Utah, United States, 84043
Contact: David Butler, PT    801-602-8803    davidb@mlrehab.com   
Principal Investigator: David Butler, PT         
United States, Virginia
Rockingham Memorial Hospital Recruiting
Harrisonburg, Virginia, United States, 22801
Contact: Dani Hargens, PT    540-433-4555    Pir8pt2004@gmail.com   
Principal Investigator: Dani Hargens, PT         
United States, Washington
Elite Physical Therapy Recruiting
Tacoma, Washington, United States, 98407
Contact: Anna DeLaRosby, PT    253-507-7450    Anna.delarosby@gmail.com   
Principal Investigator: Anna DeLaRosby, PT         
Sponsors and Collaborators
Emily Slaven, PT, PhD
Performance Dynamics
Investigators
Principal Investigator: Emily J Slaven, PhD University of Indianapolis
  More Information

No publications provided

Responsible Party: Emily Slaven, PT, PhD, Assistant Professor, University of Indianapolis
ClinicalTrials.gov Identifier: NCT01902433     History of Changes
Other Study ID Numbers: ASTYM2013
Study First Received: July 15, 2013
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 29, 2014