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Efficacy of High Energy Density Pulse Electromagnetic Field for Patients With Frozen Shoulder: 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 frozen shoulder
Frozen shoulder causes shoulder pain and limited range of motion(ROM). It is thought to afflict between 2 and 5% of the general population. Individuals of middle age are most often affected, typically during the 5th to 7th decades of life. Typical symptoms include gradual onset of shoulder pain, limited shoulder ROM at least in two or more directions (especially in external rotation). In the case of primary adhesive capsulitis, the disease is usually self-limiting, and typically lasts 18-24 months. However, persistent symptoms and movement restriction beyond 3 years have been reported in up to 40% of patients, with up to 15% of patients suffering permanent disability. Therefore, an effective treatment is necessary to treat the shoulder pain and disability caused by frozen shoulder. High energy density pulse electromagnetic field (High-PEMF), different from traditional PEMF, includes characteristics as following: 1. The short pulse duration (50μs) with a damped oscillation 2. The broad bandwidth(200kHz\~300MHz) with a basic frequency 240kHz 3. High voltages (up to 40 kV) and peak currents (up to 10 kA) arise in the applicator spool 4. Delivery of energy per pulse of about 96Ws (Joule) with a magnetic flux density of 50\~100mT 5. Depth penetration for tissue and organ up to 20 cm It has been applied in chronic tendinopathy with positive outcomes. However, few studies support its application in the setting of frozen shoulder. Hence, the aim of our study is to investigate the efficacy and the underlying possible mechanism of High-PEMF for patients with frozen shoulder.
Age
20 - 75 years
Sex
ALL
Healthy Volunteers
No
Tri-service general hospital
Taipei, Taiwan
Start Date
October 31, 2023
Primary Completion Date
October 15, 2024
Completion Date
November 30, 2024
Last Updated
January 3, 2025
17
ACTUAL participants
High energy density pulse electromagnetic field
DEVICE
physiotherapy
OTHER
sham High energy density pulse electromagnetic field
DEVICE
Lead Sponsor
Tri-Service General Hospital
NCT07368751
NCT02283996
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View ClinicalTrials.gov Terms and ConditionsNCT06725823