Clinical trial NCT05483517: High Energy Density Pulse Electromagnetic Field for Patients With Rotator Cuff Tendinopathy
Official title: Efficacy of High Energy Density Pulse Electromagnetic Field for Patients With Rotator Cuff Tendinopathy: A Double-blinded, Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tendinosis
Keywords: rotator cuff tendinopathy
high energy density pulse electromagnetic field
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Pain Visual Analogue Scale(VAS)
timeFrame: baseline, immediate after treatment, 4 weeks, 12 weeks
Secondary outcomes:
measure: Change in Total Score of Shoulder Pain and Disability Index (SPADI)
timeFrame: baseline, immediate after treatment, 4 weeks, 12 weeks
measure: Changes of Shoulder Range of Motion in Active Flexion
timeFrame: baseline, immediate after treatment, 4 weeks, 12 weeks
measure: Changes of Shoulder Range of Motion in Active Abduction
timeFrame: baseline, immediately after treatment, 4 weeks, 12 weeks
measure: Changes of Shoulder Range of Motion in Active Internal Rotation
timeFrame: baseline, immediately after treatment, 4 weeks, 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-service general hospital
state: Neihu
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, Tri-Service General
name: Liang cheng Chen, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: