NCT06969859

Pulsed Electro-Magnetic Field Therapy for Treatment of Midportion Achilles Tendinopathy

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Mid-portion Achilles Tendinopathy

Interventions

Type	Name	Description
DEVICE	PEMF	The PEMF will be delivered using a BIXEPS device (Quantum Tx, Singapore) ; It is utilised by the patient placing the leg into the machine. This device is operated by participant individualized NFC cards, which will be centrally programmed to deliver either active PEMF (uniform 1mT, 50Hz) or sham PEMF (0mT, 0Hz) for 30 minutes. Because this biophysical intervention is non-invasive, and the electromagnetic fields emitted into the legs do not generate any sensation (e.g. heat, sound), participants will be blinded to the treatment. The protocol will be 180 minutes of PEMF therapy, performed in six 30-minute sessions 3 times a week and completed in 2 weeks.
BEHAVIORAL	Alfredson eccentric training program	All participants will be subject to a standardised rehabilitation exercise region consisting of stretching and eccentric exercises following the Alfredson protocol. The 12-week program will be taught by a physiotherapist or athletic trainer and supplemented by video tutorials. The regime begins with three 30-second static stretches for the gastrocnemius (knee extension) and soleus (knee flexion) muscles with 1-minute rest between each stretch. The 2nd part is eccentric exercises to the calves following the Alfredson protocol. This will be three sets of eccentric exercises lasting 12 weeks, with 15 sets twice a day. If participants are unable to complete three sets of 15 repetitions, they can start with fewer repetitions and sets (at least 2 sets of 10 repetitions each) and gradually increase to the total number of sets. Participants will perform the static stretching exercises from Step 1 at the end of each session

Timeline

• Start date: 2025-10-15
• Primary completion: 2026-06-01
• Completion: 2027-12-31
• First posted: 2025-05-14
• Last updated: 2026-03-25

Locations

1 site across 1 country: Hong Kong