Achilles Tendinopathy, Treatment With eXercise Comparing Men and Women (ATX)

• ClinicalTrials.gov Identifier: NCT03523325
• Recruitment Status: Recruiting
• First Posted: May 14, 2018
• Last Update Posted: September 25, 2019
• Sponsor: University of Delaware
• Information provided by (Responsible Party): University of Delaware

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Achilles Tendinopathy; Achilles Tendonitis; Achilles Tendon Pain; Achilles Degeneration; Achillodynia	Other: Exercise treatment	Not Applicable

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.

Study Design

• 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

Arms and Interventions

Intervention Details:

• 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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

- Diagnosis of midportion Achilles tendinopathy

Exclusion Criteria:

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

Contacts and Locations

Contacts

Contact: Karin Gravare Silbernagel, PT, ATC, PhD; 302-831 4808; kgs@udel.edu

Locations

United States, Delaware

University of Delaware; Recruiting

Newark, Delaware, United States, 19713

Contact: Karin Gravare Silbernagel, PT, ATC, PhD

Sponsors and Collaborators

University of Delaware

More Information

• 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
• 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

Keywords provided by University of Delaware:

Tendinopathy; Tendon; Rehabilitation; Exercise treatment

Additional relevant MeSH terms:

Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries