Completed

Efficacy of High Energy Density Pulse Electromagnetic Field for Patients With Rotator Cuff Tendinopathy: A Double-blinded, Randomized Controlled Trail

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What is being tested

High energy density pulse electromagnetic field

+ physiotherapy

+ sham High energy density pulse electromagnetic field

DeviceBehavioral
Who is being recruted

Shoulder Injuries+2

+ Rotator Cuff Injuries

+ Rupture

From 20 to 75 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: January 2023
See protocol details

Summary

Principal SponsorTri-Service General Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 31, 2023

Actual date on which the first participant was enrolled.

Traditional pulse electromagnetic field (PEMF) devices have been approved by the U.S. Food and Drug Administration (FDA) to treat nonunion fractures and cleared to treat post-operative pain and edema, osteoarthritis, and plantar fasciitis. However, high level of evidence indicated that the lack of beneficial effects of PEMF on pain, function or range of motion in the treatment of shoulder pain. High energy density pulse electromagnetic field(High-PEMF) which builds up a voltage up to 30 kilovolt (kV) with shorter impulse time(50us) and broad band-width(200kHz\~300MHz) is very different from traditional PEMF. Magnetic field about 50\~150 millitesla (mT) is created and it can penetrate the body up to 20 cm. The aim of our study is to investigate the efficacy of High-PEMF for patients with rotator cuff tendinopathy.

Official TitleEfficacy of High Energy Density Pulse Electromagnetic Field for Patients With Rotator Cuff Tendinopathy: A Double-blinded, Randomized Controlled Trail
NCT05483517
Principal SponsorTri-Service General Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Shoulder InjuriesRotator Cuff InjuriesRuptureTendon InjuriesWounds and Injuries

Criteria

4 inclusion criteria required to participate
age between 20 to 75 years old
persistent shoulder pain for at least 3 months and pain VAS score >=5
positive result in any of the following physical examinations: Hawkins-Kennedy, Neer or Jobe tests
confirmed rotator cuff tendinopathy by ultrasonography or MRI
10 exclusion criteria prevent from participating
complete or full-thickness tear of rotator cuff found by ultrasonography or MRI
previous shoulder surgery
previous history of severe trauma in shoulder
cervical radiculopathy related shoulder pain or referred pain
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
The patient receives physiotherapy under the physiotherapist's guidance and high-PEMF therapy for three weeks, following two sessions a week.

Group II

Sham
The patient receives physiotherapy under the physiotherapist's guidance and sham high-PEMF therapy for three weeks, following two sessions a week.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Tri-service general hospital

Taipei, TaiwanOpen Tri-service general hospital in Google Maps
CompletedOne Study Center