Efficacy of High Energy Density Pulse Electromagnetic Field for Patients With Rotator Cuff Tendinopathy: A Double-blinded, Randomized Controlled Trail
Phase: NA
Conditions: Rotator Cuff Tendinosis
Sponsor: Tri-Service General Hospital

Official title: Efficacy of High Energy Density 
Pulse Electromagnetic Field for Patients With 
Rotator Cuff Tendinopathy: A Double-
blinded, Randomized Controlled Trail 
NCT number: NCT05483517 
document date: 2024.05.03 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Study Protocol with SAP 
 
objective(s): We aimed to evaluate the efficacy of high-energy-density pulsed 
electromagnetic field therapy combined with physiotherapy in treating rotator cuff 
tendinopathy. 
 
methods: The study had a randomized controlled trial with a two-parallel-group 
design. We included patients with RCT to compare the differences in the 
effectiveness of high PEMF in the treatment of shoulder joint mobility, pain, and 
functionality. The patients were categorized into those who received high PEMF with 
physiotherapy (high PEMF group) and those who received sham PEMF with 
physiotherapy (sham-PEMF group). The treatment course extended over 3 weeks, 
incorporating evaluations at baseline, immediately after treatment, and 4 and 12 
weeks after treatment. 
  
statistical analysis plan: Statistical analyses were performed using the IBM SPSS 
Statistics Version 22. Demographic data were analyzed using the Mann–Whitney U 
test for continuous variables and the chi-squared test or Fisher’s exact test for 
categorical variables. Within-group differences were assessed using the Wilcoxon 
signed-rank test; between-group differences were evaluated using the Mann–
Whitney U test. Statistical significance was defined as p < 0.05.