High Energy Density Pulse Electromagnetic Field for Patients With Adhensive Capsulitis

NCT ID: NCT06000254

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-21
• Study Completion Date: 2024-12-31

Brief 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

Study Design

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

Study Groups

physiotherapy and high-PEMF

The patient receives physiotherapy and high-PEMF therapy twice weekly, over a period of three weeks.

Group Type: EXPERIMENTAL

High energy density pulse electromagnetic field

Intervention Type: DEVICE

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.

physiotherapy

Intervention Type: OTHER

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.

physiotherapy and sham high-PEMF

The patient receives physiotherapy and sham high-PEMF therapy twice weekly, over a period of three weeks.

Group Type: SHAM_COMPARATOR

sham High energy density pulse electromagnetic field

Intervention Type: DEVICE

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.

physiotherapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Physicians diagnose frozen shoulder by considering the patient's medical background, conducting a physical assessment, and reviewing X-ray and ultrasound findings.

2. The symptoms endure for a duration exceeding 3 months.

3. There exists a decrease of no less than 30 degrees in a minimum of two joint angles of the affected shoulder, namely flexion, abduction, and external rotation, in comparison to the corresponding angles of the unaffected side.

Exclusion Criteria

1. Musculoskeletal ultrasound of the shoulder identifies a full-thickness tear or substantial tear in the rotator cuff tendons or presents calcific tendinitis.

2. Presence of systemic rheumatic disease.

3. Prior history of shoulder fracture or surgical intervention involving the shoulder joint.

4. Acute compression of cervical nerve root.

5. Patients displaying instability (e.g., those with signs of internal bleeding) or individuals with cancer.

6. Recent receipt of shoulder injections for treatment within the last 3 months.

7. Impaired cognitive function that hinders the patient's ability to provide informed consent or engage in rehabilitation therapy.

8. Expectant or breastfeeding women.

9. Meets any of the contraindications for high-energy electromagnetic pulse therapy: individuals with organ transplants, implanted cardiac pacemakers, defibrillators, metal implants (such as stents), cochlear implants, and those requiring 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 Chen, 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

C202305036

Identifier Type: -

Identifier Source: org_study_id