Achilles TendinopathyATXNCT03523325
Achilles Tendinopathy, Treatment With eXercise Comparing Men and Women
A study testing Exercise treatment in people with Achilles Tendinopathy and Achilles Tendonitis, run by University of Delaware at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Achilles Tendinopathy, Achilles Tendonitis, Achilles Tendon Pain
- What is being tested?
- Exercise treatment
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2018to 12 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of midportion Achilles tendinopathy
Who cannot join
- Previous Achilles tendon rupture
- Diagnosis of only insertional Achilles tendinopathy or bursitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recovery of Symptoms, Function, Tendon Structure and Mechanical Properties in Patients With Achilles Tendinopathy: A Comparison Between Men and Women
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.
Read the 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.
- Conditions
- Achilles Tendinopathy, Achilles Tendonitis, Achilles Tendon Pain, Achilles Degeneration, Achillodynia
- Being tested
- Exercise treatment
- Keywords
- Tendinopathy, Tendon, Rehabilitation, Exercise treatment
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise treatmentOther
Also called Rehabilitation exercise, Physical Therapy 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms
Victorian Institute of Sports Assessment - Achilles questionnaire (VISA-A), Scale 0-100 with higher scores indicate better outcome.
Measured: Change over time during 12 months with evaluation every 8 weeks
Tendon Structure
Ultrasound imaging of tendon structure
Measured: Change over time during 12 months with evaluation every 8 weeks
Tendon Mechanical Properties
Use of Continuous shear wave elastography to measure shear modulus and viscosity
Measured: Change over time during 12 months with evaluation every 8 weeks
Muscle-tendon function
Functional test battery consisting of one endurance heel-rise test and three jump tests
Measured: Change over time during 12 months with evaluation every 8 weeks
Secondary outcomes (7)
Activity level
Measure of daily step counts
Measured: Change over time during 12 months with evaluation every 8 weeks
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.
Measured: Change over time during 12 months with evaluation every 8 weeks
Kinesiophobia
Tampa Scale of Kinesiophobia (TSK), scale ranges from 17 to 68 where the higher scores indicate an increasing degree of kinesiophobia.
Measured: Change over time during 12 months with evaluation every 8 weeks
Physical Activity level
Physical Activity Scale (PAS), scale ranges from 1-6 with higher score indicting greater degree of physical activity.
Measured: Change over time during 12 months with evaluation every 8 weeks
Pain level
Numeric Pain rating scale, scale ranges from 0-10 with higher scores indicating greater degree of pain.
Measured: Change over time during 12 months with evaluation every 8 weeks
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.
Measured: Change over time during 12 months with evaluation every 8 weeks
Mechanical Pain Threshold
Pressure Pain Threshold
Measured: Change over time during 12 months with evaluation every 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start2 Jul 2018
- Primary completion12 Jan 2024
- Study completion12 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Achilles TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One intervention with comparison between males and females
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523325
- Sponsor's protocol ID
- 1R01AR072034-01A1
- Acronym
- ATX
- Status last verified
- Jun 2024
- First submitted
- 1 May 2018
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Smitheman HP, Lundberg M, Harnesand M, Gelfgren S, Gravare Silbernagel K. Putting the fear-avoidance model into practice - what can patients with chronic low back pain learn from patients with Achilles tendinopathy and vice versa? Braz J Phys Ther. 2023 Sep-Oct;27(5):100557. doi: 10.1016/j.bjpt.2023.100557. Epub 2023 Nov 4.
PubMed 37952338Hanlon SL, Pohlig RT, Silbernagel KG. Differences in Recovery of Tendon Health Explained by Midportion Achilles Tendinopathy Subgroups: A 6-Month Follow-up. J Orthop Sports Phys Ther. 2023 Apr;53(4):217-234. doi: 10.2519/jospt.2023.11330. Epub 2023 Jan 23.
PubMed 36688719Sigurethsson 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.
PubMed 35922770
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery of Symptoms, Function, Tendon Structure and Mechanical Properties in Patients With Achilles Tendinopathy: A Comparison Between Men and Women
- ClinicalTrials.gov ID
- NCT03523325
- Acronym / sponsor ID
- ATX / 1R01AR072034-01A1
- Conditions
- Achilles Tendinopathy, Achilles Tendonitis, Achilles Tendon Pain, Achilles Degeneration, Achillodynia
- Keywords
- Tendinopathy, Tendon, Rehabilitation, Exercise treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 14 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- One intervention with comparison between males and females
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of midportion Achilles tendinopathy
Key exclusion criteria (2 listed)
- Previous Achilles tendon rupture
- Diagnosis of only insertional Achilles tendinopathy or bursitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise treatmentAlso: Rehabilitation exercise, Physical Therapy treatmentTreatment 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 | – |
Primary outcome
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.
Tendon Structure
Time frame: Change over time during 12 months with evaluation every 8 weeks
Ultrasound imaging of tendon structure
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
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
7 secondary outcomes
Activity level
Time frame: Change over time during 12 months with evaluation every 8 weeks
Foot and Ankle related quality of life
Time frame: Change over time during 12 months with evaluation every 8 weeks
Kinesiophobia
Time frame: Change over time during 12 months with evaluation every 8 weeks
Physical Activity level
Time frame: Change over time during 12 months with evaluation every 8 weeks
Pain level
Time frame: Change over time during 12 months with evaluation every 8 weeks
General Health Status- Health related Quality of Life
Time frame: Change over time during 12 months with evaluation every 8 weeks
Mechanical Pain Threshold
Time frame: Change over time during 12 months with evaluation every 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Derived from this study: PubMed 37952338Smitheman HP, Lundberg M, Harnesand M, Gelfgren S, Gravare Silbernagel K. Putting the fear-avoidance model into practice - what can patients with chronic low back pain learn from patients with Achilles tendinopathy and vice versa? Braz J Phys Ther. 2023 Sep-Oct;27(5):100557. doi: 10.1016/j.bjpt.2023.100557. Epub 2023 Nov 4.
- Derived from this study: PubMed 36688719Hanlon SL, Pohlig RT, Silbernagel KG. Differences in Recovery of Tendon Health Explained by Midportion Achilles Tendinopathy Subgroups: A 6-Month Follow-up. J Orthop Sports Phys Ther. 2023 Apr;53(4):217-234. doi: 10.2519/jospt.2023.11330. Epub 2023 Jan 23.
- Derived from this study: PubMed 35922770Sigurethsson 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise treatment in people with Achilles Tendinopathy and Achilles Tendonitis, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms (time frame: Change over time during 12 months with evaluation every 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03523325, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.