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

NCT ID: NCT05483517

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2024-08-30

Brief Summary

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

Detailed 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.

Conditions

Rotator Cuff Tendinosis

Study Design

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

Study Groups

physiotherapy and high-PEMF

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

Group Type: EXPERIMENTAL

High energy density pulse electromagnetic field

Intervention Type: DEVICE

The treatment coil is placed over the shoulder region at the maximum pain point for 9 minutes. A normal energy of high-PEMF with a rate of 2 pulse per second is applied to the patient.

physiotherapy

Intervention Type: BEHAVIORAL

Physiotherapy includes shoulder range of motion (ROM), stretching and muscle strengthening exercises. Under the physiotherapist's guidance, the patient receives the training session about 30 minutes every time.

physiotherapy and sham high-PEMF

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

Group Type: SHAM_COMPARATOR

sham High energy density pulse electromagnetic field

Intervention Type: DEVICE

The sham treatment coil is placed over the shoulder region at the maximum pain point for 9 minutes. The setting is the same as the experimental group(normal energy, a rate of 2 pulse per second) with the difference that the energy output doesn't export to the patient.

physiotherapy

Intervention Type: BEHAVIORAL

Physiotherapy includes shoulder range of motion (ROM), stretching and muscle strengthening exercises. Under the physiotherapist's guidance, the patient receives the training session about 30 minutes every time.

Interventions

High energy density pulse electromagnetic field

The treatment coil is placed over the shoulder region at the maximum pain point for 9 minutes. A normal energy of high-PEMF with a rate of 2 pulse per second is applied to the patient.

Intervention Type: DEVICE

sham High energy density pulse electromagnetic field

The sham treatment coil is placed over the shoulder region at the maximum pain point for 9 minutes. The setting is the same as the experimental group(normal energy, a rate of 2 pulse per second) with the difference that the energy output doesn't export to the patient.

Intervention Type: DEVICE

physiotherapy

Physiotherapy includes shoulder range of motion (ROM), stretching and muscle strengthening exercises. Under the physiotherapist's guidance, the patient receives the training session about 30 minutes every time.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tri-Service General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Liang-Cheng Chen

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liang cheng Chen, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Medicine and Rehabilitation, Tri-Service General

Locations

Tri-service general hospital

Taipei, Neihu, Taiwan

Countries

Taiwan

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

A202205076

Identifier Type: -

Identifier Source: org_study_id