NCT06000254

High Energy Density Pulse Electromagnetic Field for Patients With Adhensive Capsulitis

Efficacy of High Energy Density Pulse Electromagnetic Field for Patients With Adhensive Capsulitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Tri-Service General Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of our study is to investigate the efficacy of high energy density pulse electromagnetic field for patients with adhesive capsulitis

Detailed description

Adhesive capsulitis, a condition causing shoulder pain and limited range of motion (ROM), is estimated to affect 2-5% of the general population. Typically occurring in middle-aged individuals during their 50s to 70s, it presents with gradually developing shoulder pain and restricted ROM, particularly in external rotation. In cases of primary adhesive capsulitis, the condition often resolves on its own, lasting around 18-24 months. However, some individuals experience persistent symptoms beyond 3 years, with up to 40% of patients and 15% facing lasting disability. Therefore, effective treatment is essential to alleviate the pain and disability associated with frozen shoulder. High energy density pulse electromagnetic field (High-PEMF) differs from traditional PEMF and possesses the following characteristics: Brief pulse duration (50μs) with a damped oscillation. Wide bandwidth (200kHz\~300MHz) centered around 240kHz. High voltages (up to 40 kV) and peak currents (up to 10 kA) in the applicator spool. Delivery of around 96Ws (Joule) of energy per pulse with a magnetic flux density of 50\~100mT. Tissue and organ penetration up to 20 cm. Although High-PEMF has shown positive results in chronic tendinopathy, there is limited evidence of its effectiveness in treating adhesive capsulitis. Therefore, our study aims to explore the efficacy and potential mechanisms underlying the use of High-PEMF in treating adhesive capsulitis patients.

Conditions

• Adhesive Capsulitis

Interventions

Type	Name	Description
DEVICE	High energy density pulse electromagnetic field	The treatment coil is positioned over the area of the shoulder that experiences the most pain, and it remains in place for a duration of 9 minutes. The patient is subjected to a high-energy high-PEMF with a frequency of 3 pulses per second during the session.
OTHER	physiotherapy	Physiotherapy includes a range of activities such as passive and active-assisted shoulder range of motion (ROM) exercises, Pendulum exercises, Codman's exercises, and Cross-body reach exercises. These exercises are conducted under the supervision of a physiotherapist and each training session lasts approximately 30 minutes.
DEVICE	sham High energy density pulse electromagnetic field	The sham treatment coil is positioned over the area of the shoulder where maximum pain is experienced, and it remains in place for a duration of 9 minutes. The parameters are consistent with those used in the experimental group. The key distinction lies in the fact that the energy output is not delivered to the patient.

Timeline

• Start date: 2024-02-21
• Primary completion: 2024-12-01
• Completion: 2024-12-31
• First posted: 2023-08-21
• Last updated: 2025-01-03

Locations

1 site across 1 country: Taiwan