High Energy Density Pulse Electromagnetic Field for Patients With Rotator Cuff Tendinopathy

Last updated: February 21, 2025
Sponsor: Tri-Service General Hospital
Overall Status: Completed

Phase

N/A

Condition

Sprains

Tendon Injuries

Treatment

High energy density pulse electromagnetic field

physiotherapy

sham High energy density pulse electromagnetic field

Clinical Study ID

NCT05483517
A202205076
  • Ages 20-75
  • All Genders

Study Summary

The aim of our study is to investigate the efficacy of high energy density pulse electromagnetic field for patients with rotator cuff tendinopathy

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. age between 20 to 75 years old

  2. persistent shoulder pain for at least 3 months and pain VAS score >=5

  3. positive result in any of the following physical examinations: Hawkins-Kennedy, Neeror Jobe tests

  4. confirmed rotator cuff tendinopathy by ultrasonography or MRI

Exclusion

Exclusion Criteria:

  1. complete or full-thickness tear of rotator cuff found by ultrasonography or MRI

  2. previous shoulder surgery

  3. previous history of severe trauma in shoulder

  4. cervical radiculopathy related shoulder pain or referred pain

  5. other shoulder diseases: adhesive capsulitis, calcifying tendinopathy,radiology-confirmed acromion type III, shoulder instability, degenerativeosteoarthritis, labral tear

  6. present with any of the following systemic diseases: active infection, sever anduncontrolled medical condition, cancer, immune-related or rheumatoid arthritis,hyperuricemia and gout

  7. previous treatment with articular or subacromial steroid injections within the last 3 months

  8. cognitive impairment with loss of ability to sign the agreement and receiverehabilitation

  9. pregnancy or lactating women

  10. has any of the following contraindications: Carriers of pacemakers, internaldefibrillators,internal metal implants (locally dependent), Cochlea implants,metallic stents, insulin pumps

Study Design

Total Participants: 24
Treatment Group(s): 3
Primary Treatment: High energy density pulse electromagnetic field
Phase:
Study Start date:
January 31, 2023
Estimated Completion Date:
August 30, 2024

Study Description

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(200kHz300MHz) is very different from traditional PEMF. Magnetic field about 50150 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.

Connect with a study center

  • Tri-service general hospital

    Taipei, Neihu 11490
    Taiwan

    Site Not Available

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