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Achilles Tendinopathy, Treatment With eXercise Comparing Men and Women

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03523325
Acronym
ATX
Enrollment
182
Registered
2018-05-14
Start date
2018-07-02
Completion date
2024-03-12
Last updated
2024-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achilles Degeneration, Achilles Tendinopathy, Achilles Tendonitis, Achilles Tendon Pain, Achillodynia

Keywords

Tendinopathy, Tendon, Rehabilitation, Exercise treatment

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.

Interventions

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.

Sponsors

University of Delaware
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

One intervention with comparison between males and females

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

\- Diagnosis of midportion Achilles tendinopathy

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
SymptomsChange over time during 12 months with evaluation every 8 weeksVictorian Institute of Sports Assessment - Achilles questionnaire (VISA-A), Scale 0-100 with higher scores indicate better outcome.
Tendon StructureChange over time during 12 months with evaluation every 8 weeksUltrasound imaging of tendon structure
Tendon Mechanical PropertiesChange over time during 12 months with evaluation every 8 weeksUse of Continuous shear wave elastography to measure shear modulus and viscosity
Muscle-tendon functionChange over time during 12 months with evaluation every 8 weeksFunctional test battery consisting of one endurance heel-rise test and three jump tests

Secondary

MeasureTime frameDescription
Pain levelChange over time during 12 months with evaluation every 8 weeksNumeric Pain rating scale, scale ranges from 0-10 with higher scores indicating greater degree of pain.
Activity levelChange over time during 12 months with evaluation every 8 weeksMeasure of daily step counts
Mechanical Pain ThresholdChange over time during 12 months with evaluation every 8 weeksPressure Pain Threshold
General Health Status- Health related Quality of LifeChange over time during 12 months with evaluation every 8 weeksPatient-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.
Foot and Ankle related quality of lifeChange over time during 12 months with evaluation every 8 weeksFoot and Ankle Outcome Score (FAOS) Quality of Life subscale, scale ranges from 0-100 with higher score indicate better outcome.
KinesiophobiaChange over time during 12 months with evaluation every 8 weeksTampa Scale of Kinesiophobia (TSK), scale ranges from 17 to 68 where the higher scores indicate an increasing degree of kinesiophobia.
Physical Activity levelChange over time during 12 months with evaluation every 8 weeksPhysical Activity Scale (PAS), scale ranges from 1-6 with higher score indicting greater degree of physical activity.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026