Clinical trial NCT03523325: Achilles Tendinopathy, Treatment With eXercise Comparing Men and Women
Official title: Recovery of Symptoms, Function, Tendon Structure and Mechanical Properties in Patients With Achilles Tendinopathy: A Comparison Between Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achilles Tendinopathy
Achilles Tendonitis
Achilles Tendon Pain
Achilles Degeneration
Achillodynia
Keywords: Tendinopathy
Tendon
Rehabilitation
Exercise treatment
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One intervention with comparison between males and females
Primary purpose: 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.

Eligibility criteria: Inclusion Criteria:

- Diagnosis of midportion Achilles tendinopathy

Exclusion Criteria:

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

Primary outcomes:
measure: Symptoms
timeFrame: Change over time during 12 months with evaluation every 8 weeks
measure: Tendon Structure
timeFrame: Change over time during 12 months with evaluation every 8 weeks
measure: Tendon Mechanical Properties
timeFrame: Change over time during 12 months with evaluation every 8 weeks
measure: Muscle-tendon function
timeFrame: Change over time during 12 months with evaluation every 8 weeks
Secondary outcomes:
measure: Activity level
timeFrame: Change over time during 12 months with evaluation every 8 weeks
measure: Foot and Ankle related quality of life
timeFrame: Change over time during 12 months with evaluation every 8 weeks
measure: Kinesiophobia
timeFrame: Change over time during 12 months with evaluation every 8 weeks
measure: Physical Activity level
timeFrame: Change over time during 12 months with evaluation every 8 weeks
measure: Pain level
timeFrame: Change over time during 12 months with evaluation every 8 weeks
measure: General Health Status- Health related Quality of Life
timeFrame: Change over time during 12 months with evaluation every 8 weeks
measure: Mechanical Pain Threshold
timeFrame: Change over time during 12 months with evaluation every 8 weeks
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
References:
citation: Sigurethsson HB, Couppe C, Silbernagel KG. Data driven model of midportion achilles tendinopathy health created with factor analysis. BMC Musculoskelet Disord. 2022 Aug 3;23(1):744. doi: 10.1186/s12891-022-05702-1.