Pulsed Electro-Magnetic Field Therapy for Treatment of Midportion Achilles Tendinopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PEMF, Alfredson eccentric training program.
- Who it may be relevant to
- Registry conditions: Mid-portion Achilles Tendinopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multicentre Randomised Controlled Trial of Pulsed Electro-Magnetic Field Therapy for Treatment of Midportion Achilles Tendinopathy（EM-MAT Trial)
Overview
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.
Interventions
- 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 - 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 fo
Primary outcome measures
- Victorian Institute of Sports Assessment (VISA-A) [Time frame: Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention]
Secondary outcome measures (8)
- Numeric Pain Rating Scale (NPRS) [Time frame: Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention]
- Foot and Ankle Outcome Scores (FAOS) [Time frame: Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention]
- Achilles tendon resting angle (ATRA) [Time frame: Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention]
- Tendon thickness [Time frame: Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention]
- Tendon cross sectional area [Time frame: Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention]
- Tendon vascularity [Time frame: Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention]
- Tendon elasticity [Time frame: Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention]
- Calf muscle strength [Time frame: Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention]
Eligibility criteria
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.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- Prince of Wales Hospital — Shatin
Identifiers
NCT: NCT06969859 · 2025.193