High Energy Density Pulse Electromagnetic Field for Patients With Rotator Cuff Tendinopathy

NCT05483517 | Completed Results DMC

• 1 other identifier: A202205076
• Study Type: interventional
• Target: 24
• 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 rotator cuff tendinopathy

Conditions

Rotator Cuff Tendinosis

Keywords

rotator cuff tendinopathy; high energy density pulse electromagnetic field

Outcome Measures

Primary Outcomes (1)

• Change in Pain Visual Analogue Scale(VAS)

  The Visual Analog Scale (VAS) was used to measure pain intensity. The scale ranges from 0 to 10, where 0 indicates no pain and 10 represents the worst possible pain. Higher scores indicate worse outcomes.

  baseline, immediate after treatment, 4 weeks, 12 weeks

Secondary Outcomes (4)

• Change in Total Score of Shoulder Pain and Disability Index (SPADI)

  baseline, immediate after treatment, 4 weeks, 12 weeks

• Changes of Shoulder Range of Motion in Active Flexion

  baseline, immediate after treatment, 4 weeks, 12 weeks

• Changes of Shoulder Range of Motion in Active Abduction

  baseline, immediately after treatment, 4 weeks, 12 weeks

• Changes of Shoulder Range of Motion in Active Internal Rotation

  baseline, immediately after treatment, 4 weeks, 12 weeks

Study Arms (2)

physiotherapy and high-PEMF

EXPERIMENTAL

The patient receives physiotherapy under the physiotherapist's guidance and high-PEMF therapy for three weeks, following two sessions a week.

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

physiotherapy and sham high-PEMF

SHAM COMPARATOR

The patient receives physiotherapy under the physiotherapist's guidance and sham high-PEMF therapy for three weeks, following two sessions a week.

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

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 normal energy of high-PEMF with a rate of 2 pulse per second is applied to the patient.

physiotherapy and 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(normal energy, a rate of 2 pulse per second) with the difference that the energy output doesn't export to the patient.

physiotherapy and sham high-PEMF

physiotherapy BEHAVIORAL

Physiotherapy includes shoulder range of motion (ROM), stretching and muscle strengthening 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

Eligibility Criteria

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

You may qualify if:

• age between 20 to 75 years old
• persistent shoulder pain for at least 3 months and pain VAS score \>=5
• positive result in any of the following physical examinations: Hawkins-Kennedy, Neer or Jobe tests
• confirmed rotator cuff tendinopathy by ultrasonography or MRI

You may not qualify if:

• complete or full-thickness tear of rotator cuff found by ultrasonography or MRI
• previous shoulder surgery
• previous history of severe trauma in shoulder
• cervical radiculopathy related shoulder pain or referred pain
• other shoulder diseases: adhesive capsulitis, calcifying tendinopathy, radiology-confirmed acromion type III, shoulder instability, degenerative osteoarthritis, labral tear
• present with any of the following systemic diseases: active infection, sever and uncontrolled medical condition, cancer, immune-related or rheumatoid arthritis, hyperuricemia and gout
• previous treatment with articular or subacromial steroid injections within the last 3 months
• cognitive impairment with loss of ability to sign the agreement and receive rehabilitation
• pregnancy or lactating women
• has any of the following contraindications: Carriers of pacemakers, internal defibrillators,internal metal implants (locally dependent), Cochlea implants, metallic stents, insulin pumps

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-service general hospital

Taipei, Neihu, 11490, Taiwan

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Results Point of Contact

• Title: Lai Chia-Ying
• Organization: Tri-service general hospital

pokerface165@gmail.com

87923311

Study Officials

• Liang cheng Chen, MD, MS

  Department of Physical Medicine and Rehabilitation, Tri-Service General

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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 29, 2022
• First Posted: August 2, 2022
• Study Start: January 31, 2023
• Primary Completion: April 8, 2024
• Study Completion: August 30, 2024
• Last Updated: February 25, 2025
• Results First Posted: February 25, 2025

Record last verified: 2025-02

Locations

TW (1)