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

Primary Purpose

Achilles Tendinopathy, Achilles Tendonitis, Achilles Tendon Pain

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise treatment
Sponsored by
University of Delaware
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achilles Tendinopathy focused on measuring Tendinopathy, Tendon, Rehabilitation, Exercise treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Diagnosis of midportion Achilles tendinopathy

Exclusion Criteria:

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

Sites / Locations

  • University of Delaware

Outcomes

Primary Outcome Measures

Symptoms
Victorian Institute of Sports Assessment - Achilles questionnaire (VISA-A), Scale 0-100 with higher scores indicate better outcome.
Tendon Structure
Ultrasound imaging of tendon structure
Tendon Mechanical Properties
Use of Continuous shear wave elastography to measure shear modulus and viscosity
Muscle-tendon function
Functional test battery consisting of one endurance heel-rise test and three jump tests

Secondary Outcome Measures

Activity level
Measure of daily step counts
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.
Kinesiophobia
Tampa Scale of Kinesiophobia (TSK), scale ranges from 17 to 68 where the higher scores indicate an increasing degree of kinesiophobia.
Physical Activity level
Physical Activity Scale (PAS), scale ranges from 1-6 with higher score indicting greater degree of physical activity.
Pain level
Numeric Pain rating scale, scale ranges from 0-10 with higher scores indicating greater degree of pain.
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.
Mechanical Pain Threshold
Pressure Pain Threshold

Full Information

First Posted
May 1, 2018
Last Updated
May 10, 2023
Sponsor
University of Delaware
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1. Study Identification

Unique Protocol Identification Number
NCT03523325
Brief Title
Achilles Tendinopathy, Treatment With eXercise Comparing Men and Women
Acronym
ATX
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Delaware

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendinopathy, Achilles Tendonitis, Achilles Tendon Pain, Achilles Degeneration, Achillodynia
Keywords
Tendinopathy, Tendon, Rehabilitation, Exercise treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One intervention with comparison between males and females
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Diagnosis of midportion Achilles tendinopathy Exclusion Criteria: Previous Achilles tendon rupture Diagnosis of only insertional Achilles tendinopathy or bursitis
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35922770
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.
Results Reference
derived

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Achilles Tendinopathy, Treatment With eXercise Comparing Men and Women

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