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

NCT01902433 | Terminated

• 1 other identifier: ASTYM2013
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Achilles Tendon Pain

Outcome Measures

Primary Outcomes (1)

• VISA-A

  1 year

Secondary Outcomes (1)

• Numeric Pain Rating Scale

  1 year

Study Arms (2)

Astym

EXPERIMENTAL

A form of soft tissue mobilization using instruments

Procedure: Astym

Eccentric Exercise

ACTIVE COMPARATOR

Eccentric exercise is a form of exercise where the benefit comes from applying a controlled lengthening stress to the muscle and tendon.

Procedure: Astym

Interventions

Astym PROCEDURE

Astym; Eccentric Exercise

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pain for 3 months or longer in the mid portion of only one Achilles tendon.
• Must read, speak and understand English

You may not qualify if:

• 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

Sponsors & Collaborators

• Emily Slaven, PT, PhD: lead
• Performance Dynamics: collaborator

Study Sites (2)

IU Health

Indianapolis, Indiana, 46254, United States

Location

Utah Physical Therapy

Lehi, Utah, 84043, United States

Location

Study Officials

• Emily J Slaven, PhD

  University of Indianapolis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 15, 2013
• First Posted: July 18, 2013
• Study Start: August 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 24, 2017

Record last verified: 2017-01

Locations

US (2)