Achilles tendinopathy Musculoskeletal Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female aged 19 years or older 2. Fluent in English 3. Diagnosis of unilateral or bilateral, midportion Achilles tendinopathy by a health professional (MD or physiotherapist) 4. Diagnostic criteria: Pain located in the midportion of Achilles tendon, pain during activity, the tendon is tender to palpation, pain is worsened by loading tests (e.g. heel rises or hopping) 5. Tendinopathy symptoms 3 months or greater 6. Willing to dedicate 30-40 minutes weekly to PhysViz exercises 7. VISA-A <80
Exclusion criteria
Exclusion criteria: 1. Insertional tendinopathy 2. BMI greater than 35.0 kg/m2 3. Previous or current diagnosis of Achilles tendon rupture 4. Chronic pain syndrome or systemic inflammatory diseases 5. Received corticosteroid injections in the Achilles region <3 months ago 6. Taken fluoroquinolones within the last 5 months 7. Unable to give informed consent 8. No home Wi-Fi or mobile internet 9. Severe vision impairment 10. Failed MRI screening If participants have any of the following, they will not be able to participate in the study: 11. Cardiac pacemaker, wires, or defibrillator 12. Metal fragment in the eye or orbit 13. Steel brain aneurysm clip 14. Pregnancy 15. Stainless steel Intrauterine Device (IUD) 16. Surgery or tattooing (including makeup tattoos) within the past 6 weeks If participants have any of the following, the individual’s case will be reviewed by the MR Technologist or Radiologist: 17. Artificial heart valve 18. Ear or eye implant 19. Brain aneurysm clip, titanium 20. Implanted drug infusion pump 21. Electrical stimulator for nerves or bones 22. Coil, catheter or filter in any blood vessel 23. Orthopedic hardware (artificial joint, plate, screws, rods) 24. Other metallic prostheses 25. Shrapnel, bullets, or other metallic fragments 26. Medical procedures within the past 6 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Program implementation: 1.1. Withdrawals and lost to follow-up: Will be tracked in the CONSORT flowchart, with reasons, and reported as a % of the total number of people enrolled. The feasibility target is 80% retention in the study; measured at week 12. 1.2. % prescribed time under tension and % force achieved (area under curve): Each prescribed repetition for the 12 weeks will be totalled and used as the denominator. The numerator will be the actual time spent loading the tendon or area under the curve (force x time), extracted from the PhysViz data; measured weekly, calculated at week 12. 2. Practicality: 2.1. Self-reported adverse events: Identified at the weekly check-ins or by emails or other messages sent to research staff. An arbitrary threshold would be a low rate of adverse events (<10%) and that those events are not serious in nature (e.g. causing significant injury); identified weekly, baseline to week 12. 2.2. Prescribed exercise sessions attempted and completed: The exercise session will be categorized as attempted if the session was started as indicated by PhysViz app data. It will be categorized as complete if all repetitions are initiated, even if not every repetition hits the target force level or duration. Reported as percentage of sessions attempted and completed; measured weekly from baseline to week 12. 2.3. System Usability Survey (SUS questionnaire): Usability questionnaire for rating the equipment experience, rated with a 10-item questionnaire (0-100 point scale); measured at week 12. 3. Acceptability: 3.1. Mobile application rating scale (UMARS): App usability questionnaire with 16 attributes (1 [inadequate] to 5 [excellent]). 3.2. Pain and pain tolerability of rehabilitation exercise: Researchers will report on the number of sessions in which people found their pain during exercise to be intolerable; measured weekly from baseline to week 12. 3.3. Semi-structured interview: Qualitative interview/debrief for experience with PhysViz app | — |
Secondary
| Measure | Time frame |
|---|---|
| Preliminary efficacy outcomes: 1. Achilles tendon strength: In vivo Achilles biomechanics estimation (load [N] and deformation [mm], stiffness [N/mm]) with ramped maximum voluntary contractions using a combination of real-time ultrasound, motion capture and dynamometry; measured at baseline and week 12. 2. Achilles elastic energy storage-release: In vivo Achilles hysteresis measurement (energy lost, %) during hopping using a combination of real-time ultrasound, motion capture and dynamometry; measured at baseline and week 12. 3. Morphology imaging: Achilles MRI imaging (cross-sectional area [mm2] and water content[total content]); measured at baseline and week 12. 4. VISA-A questionnaire: Achilles tendinopathy severity evaluation (0-100 point scale); measured at baseline and week 12. 5. Weekly average pain: Participant specified (0-10 point scale) weekly during exercise program; measured at baseline, weeks 0 to 12, and week 24. | — |
Countries
Canada