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Clinical Trials/NCT03523325
NCT03523325
Completed
Not Applicable

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

University of Delaware1 site in 1 country182 target enrollmentJuly 2, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Achilles Degeneration
Sponsor
University of Delaware
Enrollment
182
Locations
1
Primary Endpoint
Tendon Structure
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
July 2, 2018
End Date
March 12, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of midportion Achilles tendinopathy

Exclusion Criteria

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

Outcomes

Primary Outcomes

Tendon Structure

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

Ultrasound imaging of tendon structure

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.

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

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

Secondary Outcomes

  • Pain level(Change over time during 12 months with evaluation every 8 weeks)
  • Foot and Ankle related quality of life(Change over time during 12 months with evaluation every 8 weeks)
  • Kinesiophobia(Change over time during 12 months with evaluation every 8 weeks)
  • Activity level(Change over time during 12 months with evaluation every 8 weeks)
  • Physical Activity level(Change over time during 12 months with evaluation every 8 weeks)
  • Mechanical Pain Threshold(Change over time during 12 months with evaluation every 8 weeks)
  • General Health Status- Health related Quality of Life(Change over time during 12 months with evaluation every 8 weeks)

Study Sites (1)

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