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

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ClinicalTrials.gov Identifier: NCT01902433
Recruitment Status : Terminated (We were unable to recruit participants to the study)
First Posted : July 18, 2013
Last Update Posted : January 24, 2017
Sponsor:
Collaborator:
Performance Dynamics
Information provided by (Responsible Party):
Emily Slaven, PT, PhD, University of Indianapolis

Tracking Information
First Submitted Date  ICMJE July 15, 2013
First Posted Date  ICMJE July 18, 2013
Last Update Posted Date January 24, 2017
Study Start Date  ICMJE August 2013
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2013)
VISA-A [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01902433 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2013)
Numeric Pain Rating Scale [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Astym® Compared Eccentric Exercise for Chronic Mid-substance Achilles Tendinopathy
Official Title  ICMJE Astym® Treatment Compared With Eccentric Exercise in the Management of Chronic Mid-substance Achilles Tendinopathy: A Multisite a Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Achilles Tendon Pain
Intervention  ICMJE Procedure: Astym
Study Arms  ICMJE
  • Experimental: Astym
    A form of soft tissue mobilization using instruments
    Intervention: 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.
    Intervention: Procedure: Astym
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: July 17, 2013)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01902433
Other Study ID Numbers  ICMJE ASTYM2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Only two participants were recruited to the study at the closure of the study
Responsible Party Emily Slaven, PT, PhD, University of Indianapolis
Study Sponsor  ICMJE Emily Slaven, PT, PhD
Collaborators  ICMJE Performance Dynamics
Investigators  ICMJE
Principal Investigator: Emily J Slaven, PhD University of Indianapolis
PRS Account University of Indianapolis
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP