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

This study is ongoing, but not recruiting participants.
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: August 20, 2016
Last verified: August 2016
  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: November 2016
Estimated Primary Completion Date: August 2016 (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   (Adult)
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

Locations
United States, Indiana
IU Health
Indianapolis, Indiana, United States, 46254
United States, Utah
Utah Physical Therapy
Lehi, Utah, United States, 84043
Sponsors and Collaborators
Emily Slaven, PT, PhD
Performance Dynamics
Investigators
Principal Investigator: Emily J Slaven, PhD University of Indianapolis
  More Information

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: August 20, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: Only two participants were recruited to the study at the closure of the study

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

ClinicalTrials.gov processed this record on September 28, 2016