High Energy Density Pulse Electromagnetic Field for Patients With Frozen Shoulder

Frozen Shoulder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05979974
• Other study ID #: A202305106
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: November 2023
• Source: Tri-Service General Hospital
• Contact: Liang cheng Chen, MD, MS
• Phone: 886-2-87923311
• Email: clctsgh[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bursitis
• Frozen Shoulder

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Tri-service general hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain Visual Analogue Scale(VAS)	The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. "0" means painless and "10" means extremely painful.	the change from baseline, post-intervention immediately, post-intervention 1, 3, 6 months
Secondary	Change in Shoulder Pain and Disability Index (SPADI)	Shoulder function and disability were evaluated using the Chinese version of the Shoulder Pain and Disability Index (SPADI), a self-report questionnaire that yields pain and disability domain and total scores. The SPADI includes five questions on pain and eight questions on disability, referring to various problems with the shoulder encountered over the preceding week. Each item's score ranges from 0 (no pain/normal) to 10 (maximal pain/disability), with total scores of pain from 0-50 and disability from to 0-80. A higher score shows more disability.	the change from baseline, post-intervention immediately, post-intervention 1, 3, 6 months
Secondary	Blood test	Perform blood test to analysis the change of interleukin-1ß, interleukin-6, interleukin-10	the change from baseline, post-intervention 1 and 6 months
Secondary	Blood test	Perform blood test to analysis the change of transforming growth factor-ß(TGF-ß)	the change from baseline, post-intervention 1 and 6 months