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

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

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

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tendinosis
• Intervention / Treatment: Device: High energy density pulse electromagnetic field; Behavioral: physiotherapy; Device: sham High energy density pulse electromagnetic field

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Neihu
    • Taipei, Neihu, Taiwan, 11490
      • Tri-Service General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Behavioral: 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.
Sham Comparator: 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.	Behavioral: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Visual Analogue Scale(VAS)	The Visual Analog Scale (VAS) was used to measure pain intensity. The scale ranges from 0 to 10, where 0 indicates no pain and 10 represents the worst possible pain. Higher scores indicate worse outcomes.	baseline, immediate after treatment, 4 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total Score of Shoulder Pain and Disability Index (SPADI)	The Shoulder Pain and Disability Index (SPADI) is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with activity of daily livings (ADLs) requiring the use of the upper extremities. The pain subscale has 5-items and the Disability subscale has 8-items. The patient is instructed to choose the number that best describes their level of pain and extent of difficulty using the involved shoulder. The pain scale is summed up to a total of 50 while the disability scale sums up to 80. The total SPADI score is calculated by adding the scores of the Pain and Disability subscales, with a range from 0 to 130. A higher total score indicates greater pain and disability.	baseline, immediate after treatment, 4 weeks, 12 weeks
Changes of Shoulder Range of Motion in Active Flexion	Shoulder ROM during flexion, abduction in the sitting position, internal rotation (IR) at 90° of abduction of the affected shoulder were measured using a digital goniometer, and the mean of three values was used for analysis	baseline, immediate after treatment, 4 weeks, 12 weeks
Changes of Shoulder Range of Motion in Active Abduction	Shoulder ROM during flexion, abduction in the sitting position, internal rotation (IR) at 90° of abduction of the affected shoulder were measured using a digital goniometer, and the mean of three values was used for analysis	baseline, immediately after treatment, 4 weeks, 12 weeks
Changes of Shoulder Range of Motion in Active Internal Rotation	Shoulder ROM during flexion, abduction in the sitting position, internal rotation (IR) at 90° of abduction of the affected shoulder were measured using a digital goniometer, and the mean of three values was used for analysis	baseline, immediately after treatment, 4 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: Tri-Service General Hospital
• Investigators: Principal Investigator: Liang cheng Chen, MD, MS, Department of Physical Medicine and Rehabilitation, Tri-Service General

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2023
• Primary Completion (Actual): April 8, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: July 29, 2022
• First Submitted That Met QC Criteria: July 30, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: rotator cuff tendinopathy; high energy density pulse electromagnetic field
• Additional Relevant MeSH Terms: Shoulder Injuries; Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries; Tendinopathy
• Other Study ID Numbers: A202205076

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No