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

NCT ID: NCT06969859

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2027-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PEMF Therapy + Exercise

Group Type: EXPERIMENTAL

PEMF

Intervention Type: 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.

Alfredson eccentric training program

Intervention Type: 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

sham Therapy + Exercise

Group Type: SHAM_COMPARATOR

Alfredson eccentric training program

Intervention Type: 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

Interventions

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.

Intervention Type: DEVICE

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

Intervention Type: BEHAVIORAL

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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Samuel KK Ling

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2025.193

Identifier Type: -

Identifier Source: org_study_id