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

NCT06969859 | Recruiting DMC

• 1 other identifier: 2025.193
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Mid-portion Achilles Tendinopathy

Outcome Measures

Primary Outcomes (1)

• Victorian Institute of Sports Assessment (VISA-A)

  The primary outcome measure will be the Victorian Institute of Sport Assessment (VISA-A) questionnaire, available in either the original English or validated Chinese version, depending on the participant's native language. This specific scoring system developed for the Achilles tendon is the most widely used score for clinical Achilles research. The VISA-A is scored on a scale of 0 to 100; lower scores indicate more severity of symptoms, while a score of 100 indicates a healthy and pain-free Achilles tendon.

  Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention

Secondary Outcomes (8)

• Numeric Pain Rating Scale (NPRS)

  Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention

• Foot and Ankle Outcome Scores (FAOS)

  Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention

• Achilles tendon resting angle (ATRA)

  Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention

• Tendon thickness

  Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention

• Tendon cross sectional area

  Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention

Study Arms (2)

PEMF Therapy + Exercise

EXPERIMENTAL

Device: PEMF; Behavioral: Alfredson eccentric training program

sham Therapy + Exercise

SHAM COMPARATOR

Behavioral: Alfredson eccentric training program

Interventions

PEMF DEVICE

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.

PEMF Therapy + Exercise

Alfredson eccentric training program BEHAVIORAL

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

PEMF Therapy + Exercise; sham Therapy + Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, New Territories, 000000, Hong Kong

RECRUITING

Central Study Contacts

Samuel Ling, Dr.

CONTACT

852-35052010; samuel.ling@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor of Orthopaedics and Traumatology, CUHK Head of the Foot and Ankle Team / Honorary Associate Consultant, Prince of Wales Hospital Specialist in Orthopaedics and Traumatology, CUHK Medical Centre

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 14, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: From 2028-5-31 to 2033-5-28

Locations

HK (1)