Achilles Tendinopathy, Treatment With eXercise Comparing Men and Women

Achilles Tendinopathy Clinical Trial

— ATX  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03523325
• Other study ID #: 1R01AR072034-01A1
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis of midportion Achilles tendinopathy

Exclusion Criteria:

• Previous Achilles tendon rupture

• Diagnosis of only insertional Achilles tendinopathy or bursitis

Related Conditions & MeSH terms

• Achilles Degeneration
• Achilles Tendinopathy
• Achilles Tendon Pain
• Achilles Tendonitis
• Achillodynia
• Tendinopathy

Intervention

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.

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms	Victorian Institute of Sports Assessment - Achilles questionnaire (VISA-A), Scale 0-100 with higher scores indicate better outcome.	Change over time during 12 months with evaluation every 8 weeks
Primary	Tendon Structure	Ultrasound imaging of tendon structure	Change over time during 12 months with evaluation every 8 weeks
Primary	Tendon Mechanical Properties	Use of Continuous shear wave elastography to measure shear modulus and viscosity	Change over time during 12 months with evaluation every 8 weeks
Primary	Muscle-tendon function	Functional test battery consisting of one endurance heel-rise test and three jump tests	Change over time during 12 months with evaluation every 8 weeks
Secondary	Activity level	Measure of daily step counts	Change over time during 12 months with evaluation every 8 weeks
Secondary	Foot and Ankle related quality of life	Foot and Ankle Outcome Score (FAOS) Quality of Life subscale, scale ranges from 0-100 with higher score indicate better outcome.	Change over time during 12 months with evaluation every 8 weeks
Secondary	Kinesiophobia	Tampa Scale of Kinesiophobia (TSK), scale ranges from 17 to 68 where the higher scores indicate an increasing degree of kinesiophobia.	Change over time during 12 months with evaluation every 8 weeks
Secondary	Physical Activity level	Physical Activity Scale (PAS), scale ranges from 1-6 with higher score indicting greater degree of physical activity.	Change over time during 12 months with evaluation every 8 weeks
Secondary	Pain level	Numeric Pain rating scale, scale ranges from 0-10 with higher scores indicating greater degree of pain.	Change over time during 12 months with evaluation every 8 weeks
Secondary	General Health Status- Health related Quality of Life	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.	Change over time during 12 months with evaluation every 8 weeks
Secondary	Mechanical Pain Threshold	Pressure Pain Threshold	Change over time during 12 months with evaluation every 8 weeks