High Energy Density Pulse Electromagnetic Field for Patients With Frozen Shoulder

NCT05979974 | Terminated DMC

• 1 other identifier: A202305106
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Frozen Shoulder

Keywords

Frozen Shoulder; high energy density pulse electromagnetic field

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Shoulder Pain and Disability Index (SPADI)

  the change from baseline, post-intervention immediately, post-intervention 1, 3, 6 months

Study Arms (2)

physiotherapy and high-PEMF

EXPERIMENTAL

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

Device: High energy density pulse electromagnetic field; Other: physiotherapy

physiotherapy and sham high-PEMF

SHAM COMPARATOR

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

Other: physiotherapy; Device: sham High energy density pulse electromagnetic field

Interventions

High energy density pulse electromagnetic field 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 and high-PEMF

physiotherapy 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 high-PEMF; physiotherapy and sham high-PEMF

sham High energy density pulse electromagnetic field 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.

physiotherapy and sham high-PEMF

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Frozen shoulder is diagnosed by physicians based on the patient's medical history, physical examination, X-ray, and ultrasound reports.
• The symptoms persist for more than 3 months.
• 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.

You may not qualify if:

• Shoulder musculoskeletal ultrasound reveals a full-thickness tear or massive tear of the shoulder rotator cuff tendons or calcific tendinitis.
• Systemic rheumatic disease.
• History of shoulder fracture or previous surgical treatment of the shoulder joint.
• Acute cervical nerve root compression.
• Patients with instability (e.g., those with symptoms of internal bleeding) or cancer patients.
• Received shoulder injections for treatment within the past 3 months.
• Impaired cognitive function that prevents the patient from providing informed consent or participating in rehabilitation therapy.
• Pregnant or breastfeeding women.
• 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.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-service general hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Bursitis

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Liang cheng Chiang, MD, MS

  Department of Physical Medicine and Rehabilitation, Tri-Service General

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 30, 2023
• First Posted: August 7, 2023
• Study Start: October 31, 2023
• Primary Completion: October 15, 2024
• Study Completion: November 30, 2024
• Last Updated: January 3, 2025

Record last verified: 2024-12

Locations

TW (1)