Augmenting Standard Rehabilitation With Blood Flow Restriction for Chronic Achilles Tendinopathy (NCT07699497) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Augmenting Standard Rehabilitation With Blood Flow Restriction for Chronic Achilles Tendinopathy
Egypt80 participantsStarted 2025-08-01
Plain-language summary
Chronic insertional Achilles tendinopathy is a common overuse condition that can be slow to improve with traditional loading-based rehab (e.g., eccentric loading, activity modification, graded return to function). Outcomes are often variable, and persistent symptoms can limit how much load patients can tolerate early in rehab.
This outpatient randomized controlled trial will compare standard-of-care rehabilitation alone versus standard-of-care rehabilitation plus blood flow restriction (BFR) training in adults with chronic insertional Achilles tendinopathy. BFR uses an external cuff to partially restrict blood flow during low-load resistance exercise, aiming to produce strength and hypertrophy adaptations with less mechanical stress than high-load training. Evidence supporting BFR's physiologic effects and safety in musculoskeletal rehab is summarized in clinical research literature.
Participants will be randomized (stratified by baseline activity level and symptom severity) to receive the same rehab program, with the experimental group performing strengthening with BFR using Smart Tools Plus cuffs applied at the proximal thigh and set to 40-80% limb occlusion pressure. The primary outcome will be the VISA-A score (a validated measure of Achilles tendinopathy severity), with secondary outcomes including pain ratings, functional performance tests (e.g., single-leg heel raise endurance, hopping/time-to fatigue), and calf strength via handheld dynamometry.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-65 years
* Chronic insertional Achilles tendinopathy (symptoms \>3 months but \<3 years)
* VISA-A score \<80
* Confirmed diagnosis via:
* Palpation pain within 2 cm of calcaneal insertion
* Positive single leg-hop test
* Ultrasound or MRI evidence of structural tendon changes (hypoechoic areas, thickening, or Doppler flow)
* No prior BFR training as part of rehab within the last 3 months
Exclusion Criteria:
* Inability to give informed consent
* Uncontrolled blood pressure (\>160/100 mmHg)
* Uncontrolled diabetes
* Familial hypercholesterolemia
* History of deep vein thrombosis
* History of blood clots
* Hypercoagulable states
* Cancer
* Active infection
* History of sickle cell anemia
* Peripheral vascular disease
* Morbid obesity (BMI \>40)
* End-stage renal disease requiring dialysis
* Alcohol use disorder / alcohol abuse
* Claustrophobia
* Pregnant woman
* Inability to follow study protocol (e.g., cannot attend visits or comprehend instructions)
* Psychiatric illness preventing comprehension or interfering with follow up
* Lymphadenectomy
* Any clinical finding that places the patient at health risk, impacts the study, or affects completion
* History of Achilles tendon rupture or surgery
* Concurrent midportion Achilles tendinopathy or other ankle pathology (e.g., arthritis)
* Recent treatments within the past 3 months: physiotherapy, local injections, shockwave therapy, orthotic use
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
VISA-A (Victorian Institute of Sport Assessment-Achilles) Score
Timeframe: Baseline (pre-intervention) and Week 8 (end of intervention period)