NCT05979974

High Energy Density Pulse Electromagnetic Field for Patients With Frozen Shoulder

Efficacy of High Energy Density Pulse Electromagnetic Field for Patients With Frozen Shoulder: A Double-blinded, Randomized Controlled Trail

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (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 frozen shoulder

Detailed description

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.

Conditions

• Frozen Shoulder

Interventions

Type	Name	Description
DEVICE	High energy density pulse electromagnetic field	The treatment coil is placed over the shoulder region at the maximum pain point for 9 minutes. A high energy of high-PEMF with a rate of 3 pulse per second is applied to the patient.
OTHER	physiotherapy	Physiotherapy such as shoulder passive and active-assisted range of motion (ROM) exercises, Pendulum exercises, Codman's exercises and Cross-body reach exercises. Under the physiotherapist's guidance, the patient receives the training session about 30 minutes every time.
DEVICE	sham High energy density pulse electromagnetic field	The sham treatment coil is placed over the shoulder region at the maximum pain point for 9 minutes. The setting is the same as the experimental group(high energy, a rate of 3 pulse per second) with the difference that the energy output doesn't export to the patient.

Timeline

• Start date: 2023-10-31
• Primary completion: 2024-10-15
• Completion: 2024-11-30
• First posted: 2023-08-07
• Last updated: 2025-01-03

Locations

1 site across 1 country: Taiwan