N/A N=24 Randomized Triple-blind Treatment

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

Rotator Cuff Tendinosis

Bottom Line

View on ClinicalTrials.gov: NCT05483517 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2025

Primary outcome: Primary: Change in Pain Visual Analogue Scale(VAS) — 5.91; 5.90; 4.73; 4.60 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: High energy density pulse electromagnetic field (Device); sham High energy density pulse electromagnetic field (Device); physiotherapy (Behavioral)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Tri-Service General Hospital
Primary completion: Apr 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Pain Visual Analogue Scale(VAS)	5.91; 5.90; 4.73; 4.60; 3.55; 4.90	—
SECONDARY Change in Total Score of Shoulder Pain and Disability Index (SPADI)	58.27; 65.80; 39.18; 52.40; 41.27; 60.20	—
SECONDARY Changes of Shoulder Range of Motion in Active Flexion	143.74; 154.11; 147.76; 152.53; 144.89; 149.79	—
SECONDARY Changes of Shoulder Range of Motion in Active Abduction	142.51; 153.79; 147.16; 154.22; 152.93; 153.00	—
SECONDARY Changes of Shoulder Range of Motion in Active Internal Rotation	60.75; 73.03; 68.46; 73.33; 71.19; 80.94	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05483517). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.