Achilles Tendinopathy, Treatment With eXercise Comparing Men and Women (ATX)
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ClinicalTrials.gov Identifier: NCT03523325 |
Recruitment Status :
Recruiting
First Posted : May 14, 2018
Last Update Posted : September 25, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Achilles Tendinopathy Achilles Tendonitis Achilles Tendon Pain Achilles Degeneration Achillodynia | Other: Exercise treatment | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | One intervention with comparison between males and females |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Recovery of Symptoms, Function, Tendon Structure and Mechanical Properties in Patients With Achilles Tendinopathy: A Comparison Between Men and Women |
Actual Study Start Date : | July 2, 2018 |
Estimated Primary Completion Date : | March 31, 2023 |
Estimated Study Completion Date : | March 31, 2023 |

- Other: Exercise treatment
Treatment protocol is an exercise program consisting of four different phases (Silbernagel protocol). The progression consists of increasing number of repetitions, resistance, speed and range of motion of the exercises. A pain-monitoring model is used to adjust the exercise loads and progression through the four phases.Other Names:
- Rehabilitation exercise
- Physical Therapy treatment
- Symptoms [ Time Frame: Change over time during 12 months with evaluation every 8 weeks ]Victorian Institute of Sports Assessment - Achilles questionnaire (VISA-A), Scale 0-100 with higher scores indicate better outcome.
- Tendon Structure [ Time Frame: Change over time during 12 months with evaluation every 8 weeks ]Ultrasound imaging of tendon structure
- Tendon Mechanical Properties [ Time Frame: Change over time during 12 months with evaluation every 8 weeks ]Use of Continuous shear wave elastography to measure shear modulus and viscosity
- Muscle-tendon function [ Time Frame: Change over time during 12 months with evaluation every 8 weeks ]Functional test battery consisting of one endurance heel-rise test and three jump tests
- Activity level [ Time Frame: Change over time during 12 months with evaluation every 8 weeks ]Measure of daily step counts
- Foot and Ankle related quality of life [ Time Frame: Change over time during 12 months with evaluation every 8 weeks ]Foot and Ankle Outcome Score (FAOS) Quality of Life subscale, scale ranges from 0-100 with higher score indicate better outcome.
- Kinesiophobia [ Time Frame: Change over time during 12 months with evaluation every 8 weeks ]Tampa Scale of Kinesiophobia (TSK), scale ranges from 17 to 68 where the higher scores indicate an increasing degree of kinesiophobia.
- Physical Activity level [ Time Frame: Change over time during 12 months with evaluation every 8 weeks ]Physical Activity Scale (PAS), scale ranges from 1-6 with higher score indicting greater degree of physical activity.
- Pain level [ Time Frame: Change over time during 12 months with evaluation every 8 weeks ]Numeric Pain rating scale, scale ranges from 0-10 with higher scores indicating greater degree of pain.
- General Health Status- Health related Quality of Life [ Time Frame: Change over time during 12 months with evaluation every 8 weeks ]Patient-Reported Outcomes Measurement Information System® (PROMIS) - 29, measures health-related quality of life consisting of 29 question survey divided into seven sub-domains of function including physical functioning, social function, pain interference, pain intensity, sleep, depression, and anxiety.
- Mechanical Pain Threshold [ Time Frame: Change over time during 12 months with evaluation every 8 weeks ]Pressure Pain Threshold

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of midportion Achilles tendinopathy
Exclusion Criteria:
- Previous Achilles tendon rupture
- Diagnosis of only insertional Achilles tendinopathy or bursitis

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523325
Contact: Karin Gravare Silbernagel, PT, ATC, PhD | 302-831 4808 | kgs@udel.edu |
United States, Delaware | |
University of Delaware | Recruiting |
Newark, Delaware, United States, 19713 | |
Contact: Karin Gravare Silbernagel, PT, ATC, PhD |
Responsible Party: | University of Delaware |
ClinicalTrials.gov Identifier: | NCT03523325 |
Other Study ID Numbers: |
1R01AR072034-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | May 14, 2018 Key Record Dates |
Last Update Posted: | September 25, 2019 |
Last Verified: | September 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Tendinopathy Tendon Rehabilitation Exercise treatment |
Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendon Injuries Wounds and Injuries |