Clinical trial NCT06969859: Pulsed Electro-Magnetic Field Therapy for Treatment of Midportion Achilles Tendinopathy
Official title: Multicentre Randomised Controlled Trial of Pulsed Electro-Magnetic Field Therapy for Treatment of Midportion Achilles Tendinopathy（EM-MAT Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mid-portion Achilles Tendinopathy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.)

Primary outcomes:
measure: Victorian Institute of Sports Assessment (VISA-A)
timeFrame: Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention
Secondary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention
measure: Foot and Ankle Outcome Scores (FAOS)
timeFrame: Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention
measure: Achilles tendon resting angle (ATRA)
timeFrame: Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention
measure: Tendon thickness
timeFrame: Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention
measure: Tendon cross sectional area
timeFrame: Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention
measure: Tendon vascularity
timeFrame: Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention
measure: Tendon elasticity
timeFrame: Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention
measure: Calf muscle strength
timeFrame: Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention
Other outcomes:
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