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Completed

NCT Number: NCT03523325

Achilles Tendinopathy, Treatment With eXercise Comparing Men and Women

This study will evaluate if there is a difference in recovery of tendon structure and mechanical properties between males and females with Achilles tendinopathy receiving exercise treatment. It will evaluate recovery of tendinopathy with exercise intervention using outcome measures for tendon structure and mechanical properties along with validated measures of muscle-tendon function and symptoms.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware

Newark, Delaware, 19713, United States

About this study

Achilles tendinopathy has an incidence rate of 2.35 per 1000 in the general population and is most prevalent in middle-aged individuals (35-55 y/o), but occurs in men and women of all ages. The primary symptom is pain during daily activities such as walking and exercising such as running. Aside from the pain, Achilles tendinopathy has been shown to significantly decrease physical activity level, resulting in further negative effects on overall health and well-being. The treatment for Achilles tendinopathy with the highest level of evidence is eccentric exercise, providing mechanical loading of the muscle-tendon unit. In a recent systematic review, all studies reported significant improvements in patient-reported symptoms but at 12 weeks the means ranged from 69-80 (100 being fully recovered) indicating that even with the most effective treatment individuals continued to have symptoms. At this time, other more invasive interventions such as injection therapies (ex. platelet-rich plasma) and surgery are recommended for patients who fail exercise treatment despite a lack of understanding of what factors are related to continued problems. Just achieving a reduction in pain and symptoms with treatment also does not ensure resolution of the tendon's structural abnormalities. In fact, studies evaluating the recovery of tendon structure with exercise suggest that at least 24 weeks may be needed to observe a significant change. Other individual factors such as sex, degree of tendon structural damage and functional deficits are also proposed to influence both the time course and success rate of recovery. The long-term goal of our research is to advance understanding of tendon injuries and repair, enabling tailored treatments to be developed. This study begins to address this long-term goal by evaluating the time-course of recovery in terms of tendon structure (ultrasound imaging) and viscoelastic properties (elastography) along with symptoms (patient-reported outcomes) and muscle-tendon function (functional test-battery) in males and females with Achilles tendinopathy treated with an exercise program. Aim 1 is to evaluate if there are differences in change over time in symptoms, muscle-tendon function, tendon structure, and mechanical properties between males and females with Achilles tendinopathy receiving exercise treatment. Aim 2 is to investigate whether the presence and magnitude of tendon structural abnormality at baseline will affect the ability and time-course of recovery with exercise treatment for Achilles tendinopathy. Aim 3 is to explore if patients who continue to have symptoms at the 16-week evaluation will further improve in symptoms, muscle-tendon function, tendon structure and mechanical properties over the course of one year.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of midportion Achilles tendinopathy

Exclusion criteria

  • Previous Achilles tendon rupture
  • Diagnosis of only insertional Achilles tendinopathy or bursitis

Treatment and study plan

Exercise treatment

Other

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

Primary outcomes

  1. 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.

  2. Tendon Structure

    Time frame: Change over time during 12 months with evaluation every 8 weeks

    Ultrasound imaging of tendon structure

  3. 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

  4. 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

Secondary outcomes

  1. Activity level

    Time frame: Change over time during 12 months with evaluation every 8 weeks

    Measure of daily step counts

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Mechanical Pain Threshold

    Time frame: Change over time during 12 months with evaluation every 8 weeks

    Pressure Pain Threshold

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Registry information

Official study title

Recovery of Symptoms, Function, Tendon Structure and Mechanical Properties in Patients With Achilles Tendinopathy: A Comparison Between Men and Women

Acronym: ATX

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
May 14, 2018
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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