High Energy Density Pulse Electromagnetic Field for Patients With Adhensive Capsulitis

NCT06000254 | Completed

• 1 other identifier: C202305036
• Study Type: interventional
• Target: 13
• 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 adhesive capsulitis

Conditions

Adhesive Capsulitis

Keywords

adhesive capsulitis; 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 receives physiotherapy and high-PEMF therapy twice weekly, over a period of three weeks.

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

physiotherapy and sham high-PEMF

SHAM COMPARATOR

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

physiotherapy 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 high-PEMF; physiotherapy and sham high-PEMF

sham High energy density pulse electromagnetic field 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 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:

• Physicians diagnose frozen shoulder by considering the patient's medical background, conducting a physical assessment, and reviewing X-ray and ultrasound findings.
• The symptoms endure for a duration exceeding 3 months.
• 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.

You may not qualify if:

• Musculoskeletal ultrasound of the shoulder identifies a full-thickness tear or substantial tear in the rotator cuff tendons or presents calcific tendinitis.
• Presence of systemic rheumatic disease.
• Prior history of shoulder fracture or surgical intervention involving the shoulder joint.
• Acute compression of cervical nerve root.
• Patients displaying instability (e.g., those with signs of internal bleeding) or individuals with cancer.
• Recent receipt of shoulder injections for treatment within the last 3 months.
• Impaired cognitive function that hinders the patient's ability to provide informed consent or engage in rehabilitation therapy.
• Expectant or breastfeeding women.
• 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.

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 Chen, 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: August 12, 2023
• First Posted: August 21, 2023
• Study Start: February 21, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: January 3, 2025

Record last verified: 2024-12

Locations

TW (1)