Actively Recruiting
Evaluation of Adding Low-intensity Percutaneous Electrolysis to Conservative Treatment of Noninsertional Achilles Tendinopathy: A Randomized Controlled Trial
Led by Maimonides University · Updated on 2026-04-29
102
Participants Needed
1
Research Sites
52 weeks
Total Duration
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AI-Summary
What this Trial Is About
Achilles tendinopathy is a common tendon injury caused by overuse, affecting adults with an incidence of 2.35 cases per 1,000 people. Up to 29% of patients do not respond well to standard conservative treatments. This trial aims to assess whether adding low intensity percutaneous electrolysis to a high load eccentric exercise program can improve function in adults with Achilles tendinopathy. It is a randomized, triple-blind, controlled clinical trial with follow-ups at 26 and 52 weeks. Participants will be randomly assigned to one of two groups. The experimental group will receive a weekly ultrasound-guided application of low intensity galvanic currents via an acupuncture needle near the Achilles tendon. The control group will undergo a simulated treatment that mimics the procedure without actual current delivery. Both groups will follow a daily high load eccentric exercise program based on the Silbernagel protocol, which includes progressive heel-raising exercises. Throughout the 52-week study, participants will be regularly assessed using the Victorian Institute of Sport Assessment - Achilles, visual analog pain scale, Foot and Ankle Ability Measure, ultrasound shear wave elastography, and MRI scores. These evaluations will occur weekly for the first 12 weeks and again at 26 and 52 weeks to monitor changes in pain, function, tendon structure, and morphology. The study involves detailed monitoring of symptoms and imaging to determine treatment effects over time.
CONDITIONS
Brief Title
Efficacy of Percutaneous Electrolysis in the Treatment of Achilles Tendinopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Symptoms in one or both Achilles tendons lasting at least two months
- Pain score of at least 3 on a visual analog scale reproducible by palpation 2 to 6 cm above the heel bone
- Evidence of tendinopathy confirmed by MRI
- Presence of post-static dyskinesia
- Agree to avoid other treatments for Achilles tendon pain during the study
- Willing to stop using NSAIDs for at least 14 days before baseline and during the trial
You will not qualify if you...
- Pregnancy or suspicion of pregnancy
- Previous surgery on the symptomatic Achilles tendon
- Partial or total rupture of the symptomatic Achilles tendon
- Chronic ankle instability on the affected side
- Other conditions causing Achilles region pain like osteoarthritis or impingement
- Arthritis or metabolic/endocrine disorders such as diabetes
- Psychological disorders
- History of cancer
- Use of quinolones or fluoroquinolones in the past two years
- Use of statins for more than two months
- Recent treatments around the Achilles tendon with anesthetics, corticosteroids, or other drugs within three months
- Needle phobia
- Allergy to metals
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive a single weekly device intervention of low intensity percutaneous electrolysis or a sham application, combined with daily heel raising exercises following the Silbernagel protocol.
Weekly visits for up to 12 weeks
Duration - 40 weeks
Participants continue to be assessed for outcomes up to 52 weeks following treatment to monitor long-term effects.
Visits at Week 26 and Week 52
Trial Site Locations
Total: 1 location
1
Maimonides University
Buenos Aires, Buenos Aires F.D., Argentina, 1405
Actively Recruiting
Research Team
S
Santiago M d'Almeida, PT SCS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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