Pulsed Electro-Magnetic Field Therapy for Treatment of Midportion Achilles Tendinopathy (EM-MAT)

The Chinese University of Hong Kong

Status: Not yet enrolling

Conditions: Mid-portion Achilles Tendinopathy

Treatments: Device: PEMF; Behavioral: Alfredson eccentric training program

Study type: Interventional

Funder types: Other

Identifiers

NCT06969859

2025.193

Details and patient eligibility

About

This is a multi-centre, randomised, double-blind, placebo-controlled trial with two parallel groups in a 1:1 allocation to study the efficacy of Pulsed Electromagnetic Field Therapy (PEMF) in patients with mid-portion Achilles tendinopathy. All participants will be randomly divided into two groups: an intervention group (active PEMF and standard rehabilitation exercise) and a control group (sham PEMF and standard rehabilitation exercise). All self-reported, functional, and ultrasound findings will be evaluated by the investigator at baseline assessment, 1-month, 2-month, 3-month, 6-month and 12-month follow-up after initiating the intervention.

The researcher will obtain written consent from all participants before the start of this study. All eligible participants will be informed about this study and given enough time to consider whether or not to participate; the clinician/research staff will answer all questions asked by the participants. The trial will be conducted in accordance with the Declaration of Helsinki and the ICH-GCP. Clinical research ethics approval for the trial will be obtained from the Joint Clinical Research Ethics Committee of The Chinese University of Hong Kong. All participants will be recruited from the clinics and centres of the participating institutions.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults (>18 years of age)
• Clinical diagnosis of mid-Achilles tendinopathy
• VISA-A score of <60
• Ultrasound evidence of Achilles tendinopathy (thickening >7mm)

Exclusion criteria

• Previous invasive treatment to the Achilles tendon (e.g. rupture repair, PRP injection etc)
• Contraindication to PEMF (e.g. pregnancy, pacemakers)
• Physical or psychological comorbidities impairing the ability to complete assessments (eg neurological deficits etc.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

PEMF Therapy + Exercise

Experimental group

Treatment:

Behavioral: Alfredson eccentric training program

Device: PEMF

sham Therapy + Exercise

Sham Comparator group

Treatment:

Behavioral: Alfredson eccentric training program