High Energy Density Pulse Electromagnetic Field for Patients With Frozen Shoulder

NCT ID: NCT05979974

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2024-11-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

physiotherapy and high-PEMF

The patient undergoes physiotherapy and high-PEMF therapy twice a week, for a duration of three weeks.

Group Type: EXPERIMENTAL

High energy density pulse electromagnetic field

Intervention Type: DEVICE

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.

physiotherapy

Intervention Type: OTHER

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.

physiotherapy and sham high-PEMF

The patient undergoes physiotherapy and sham high-PEMF therapy twice a week, for a duration of three weeks.

Group Type: SHAM_COMPARATOR

physiotherapy

Intervention Type: OTHER

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.

sham High energy density pulse electromagnetic field

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Frozen shoulder is diagnosed by physicians based on the patient's medical history, physical examination, X-ray, and ultrasound reports.

2. The symptoms persist for more than 3 months.

3. There is a reduction of at least 30 degrees in at least two of the affected shoulder joint angles compared to the angles of the healthy side: shoulder flexion, abduction, and external rotation.

Exclusion Criteria

1. Shoulder musculoskeletal ultrasound reveals a full-thickness tear or massive tear of the shoulder rotator cuff tendons or calcific tendinitis.

2. Systemic rheumatic disease.

3. History of shoulder fracture or previous surgical treatment of the shoulder joint.

4. Acute cervical nerve root compression.

5. Patients with instability (e.g., those with symptoms of internal bleeding) or cancer patients.

6. Received shoulder injections for treatment within the past 3 months.

7. Impaired cognitive function that prevents the patient from providing informed consent or participating in rehabilitation therapy.

8. Pregnant or breastfeeding women.

9. Meets any of the contraindications for high-energy electromagnetic pulse therapy: organ transplant recipients; individuals with implanted cardiac pacemakers, defibrillators, metal implants (such as stents), cochlear implants, and insulin supplementation.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tri-Service General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Liang-Cheng Chen

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liang cheng Chiang, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Medicine and Rehabilitation, Tri-Service General

Locations

Tri-service general hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

A202305106

Identifier Type: -

Identifier Source: org_study_id