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

Sponsor
Emily Slaven, PT, PhD (Other)
Overall Status
Terminated
CT.gov ID
NCT01902433
Collaborator
Performance Dynamics (Other)
50
Enrollment
2
Locations
2
Arms
41
Duration (Months)
25
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Astym
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (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
Study Start Date :
Aug 1, 2013
Actual Primary Completion Date :
Jan 1, 2017
Actual Study Completion Date :
Jan 1, 2017

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. VISA-A [1 year]

Secondary Outcome Measures

  1. Numeric Pain Rating Scale [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Locations

Site City State Country Postal Code
1 IU Health Indianapolis Indiana United States 46254
2 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Emily Slaven, PT, PhD, Assistant Professor, University of Indianapolis
ClinicalTrials.gov Identifier:
NCT01902433
Other Study ID Numbers:
  • ASTYM2013
First Posted:
Jul 18, 2013
Last Update Posted:
Jan 24, 2017
Last Verified:
Jan 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:
Tendinopathy

Study Results

No Results Posted as of Jan 24, 2017