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

Not Applicable

Completed

Conditions: Rotator Cuff Tendinosis

Interventions: Device: sham High energy density pulse electromagnetic field
Device: High energy density pulse electromagnetic field
Behavioral: physiotherapy

Registration Number: NCT05483517

Lead Sponsor: Tri-Service General Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

Inclusion Criteria

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

Exclusion Criteria

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
other shoulder diseases: adhesive capsulitis, calcifying tendinopathy, radiology-confirmed acromion type III, shoulder instability, degenerative osteoarthritis, labral tear
present with any of the following systemic diseases: active infection, sever and uncontrolled medical condition, cancer, immune-related or rheumatoid arthritis, hyperuricemia and gout
previous treatment with articular or subacromial steroid injections within the last 3 months
cognitive impairment with loss of ability to sign the agreement and receive rehabilitation
pregnancy or lactating women
has any of the following contraindications: Carriers of pacemakers, internal defibrillators,internal metal implants (locally dependent), Cochlea implants, metallic stents, insulin pumps

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
physiotherapy and high-PEMF	physiotherapy	The patient receives physiotherapy under the physiotherapist's guidance and high-PEMF therapy for three weeks, following two sessions a week.
physiotherapy and sham high-PEMF	sham High energy density pulse electromagnetic field	The patient receives physiotherapy under the physiotherapist's guidance and sham high-PEMF therapy for three weeks, following two sessions a week.
physiotherapy and sham high-PEMF	physiotherapy	The patient receives physiotherapy under the physiotherapist's guidance and sham high-PEMF therapy for three weeks, following two sessions a week.
physiotherapy and high-PEMF	High energy density pulse electromagnetic field	The patient receives physiotherapy under the physiotherapist's guidance and high-PEMF therapy for three weeks, following two sessions a week.

Primary Outcome Measures

Name	Time	Method
Change in Pain Visual Analogue Scale(VAS)	baseline, immediate after treatment, 4 weeks, 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in Total Score of Shoulder Pain and Disability Index (SPADI)	baseline, immediate after treatment, 4 weeks, 12 weeks	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.
Changes of Shoulder Range of Motion in Active Flexion	baseline, immediate after treatment, 4 weeks, 12 weeks	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
Changes of Shoulder Range of Motion in Active Abduction	baseline, immediately after treatment, 4 weeks, 12 weeks	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
Changes of Shoulder Range of Motion in Active Internal Rotation	baseline, immediately after treatment, 4 weeks, 12 weeks	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