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

Tri-Service General Hospital

Status: Completed

Conditions: Rotator Cuff Tendinosis

Treatments: Behavioral: physiotherapy; Device: High energy density pulse electromagnetic field; Device: sham High energy density pulse electromagnetic field

Study type: Interventional

Funder types: Other

Identifiers

NCT05483517

A202205076

Details and patient eligibility

About

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

Full 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(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.

Enrollment: 24 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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, Neer or Jobe tests
4. confirmed rotator cuff tendinopathy by ultrasonography or MRI

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, degenerative osteoarthritis, labral tear
6. present with any of the following systemic diseases: active infection, sever and uncontrolled 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 receive rehabilitation
9. pregnancy or lactating women
10. has any of the following contraindications: Carriers of pacemakers, internal defibrillators,internal metal implants (locally dependent), Cochlea implants, metallic stents, insulin pumps

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups

physiotherapy and high-PEMF

Experimental group

Description:

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

Treatment:

Device: High energy density pulse electromagnetic field

Behavioral: physiotherapy

physiotherapy and sham high-PEMF

Sham Comparator group

Description:

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

Treatment:

Device: sham High energy density pulse electromagnetic field

Behavioral: physiotherapy