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NCT05483517

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

Completed NA Results posted Last updated 25 February 2025
What this trial tests

NA trial testing High energy density pulse electromagnetic field in Rotator Cuff Tendinosis in 24 participants. Completed in 30 August 2024.

Timeline
31 January 2023
Primary endpoint
8 April 2024
30 August 2024

Quick facts

Lead sponsorTri-Service General Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment24
Start date31 January 2023
Primary completion8 April 2024
Estimated completion30 August 2024
Sites1 location across Taiwan

Drugs / interventions tested

Conditions studied

Sponsor

Tri-Service General Hospital

Who can join

Adults 20 to 75, any sex, with Rotator Cuff Tendinosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Pain Visual Analogue Scale(VAS) Primary · baseline, immediate after treatment, 4 weeks, 12 weeks

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
GroupValue95% CI
Physiotherapy and High-PEMF5.91± 2.51
Physiotherapy and Sham High-PEMF5.90± 1.91
immediate after treatment
GroupValue95% CI
Physiotherapy and High-PEMF4.73± 2.37
Physiotherapy and Sham High-PEMF4.60± 2.27
4 weeks
GroupValue95% CI
Physiotherapy and High-PEMF3.55± 1.69
Physiotherapy and Sham High-PEMF4.90± 1.52
12 weeks
GroupValue95% CI
Physiotherapy and High-PEMF3.72± 2.61
Physiotherapy and Sham High-PEMF3.50± 1.27
Change in Total Score of Shoulder Pain and Disability Index (SPADI) Secondary · baseline, immediate after treatment, 4 weeks, 12 weeks

The Shoulder Pain and Disability Index (SPADI) is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with activity of daily livings (ADLs) requiring the use of the upper extremities. The pain subscale has 5-items and the Disability subscale has 8-items. The patient is instructed to choose the number that best describes their level of pain and extent of difficulty using the involved shoulder. The pain scale is summed up to a total of 50 while the disability scale sums up to 80. The total SPADI score is calculated by adding the scores of the Pain and D

baseline
GroupValue95% CI
Physiotherapy and High-PEMF58.27± 22.85
Physiotherapy and Sham High-PEMF65.80± 32.25
immediate after treatment
GroupValue95% CI
Physiotherapy and High-PEMF39.18± 25.13
Physiotherapy and Sham High-PEMF52.40± 26.83
4 weeks
GroupValue95% CI
Physiotherapy and High-PEMF41.27± 30.21
Physiotherapy and Sham High-PEMF60.20± 41.16
12 weeks
GroupValue95% CI
Physiotherapy and High-PEMF33.27± 21.28
Physiotherapy and Sham High-PEMF30.80± 33.27
Changes of Shoulder Range of Motion in Active Flexion Secondary · baseline, immediate after treatment, 4 weeks, 12 weeks

Shoulder ROM during flexion, abduction in the sitting position, internal rotation (IR) at 90° of abduction of the affected shoulder were measured using a digital goniometer, and the mean of three values was used for analysis

baseline
GroupValue95% CI
Physiotherapy and High-PEMF143.74± 20.18
Physiotherapy and Sham High-PEMF154.11± 23.47
immediately
GroupValue95% CI
Physiotherapy and High-PEMF147.76± 19.81
Physiotherapy and Sham High-PEMF152.53± 24.93
4 weeks
GroupValue95% CI
Physiotherapy and High-PEMF144.89± 21.66
Physiotherapy and Sham High-PEMF149.79± 24.70
12 weeks
GroupValue95% CI
Physiotherapy and High-PEMF148.25± 22.54
Physiotherapy and Sham High-PEMF159.29± 25.29
Changes of Shoulder Range of Motion in Active Abduction Secondary · baseline, immediately after treatment, 4 weeks, 12 weeks

Shoulder ROM during flexion, abduction in the sitting position, internal rotation (IR) at 90° of abduction of the affected shoulder were measured using a digital goniometer, and the mean of three values was used for analysis

baseline
GroupValue95% CI
Physiotherapy and High-PEMF142.51± 24.13
Physiotherapy and Sham High-PEMF153.79± 26.34
immediately
GroupValue95% CI
Physiotherapy and High-PEMF147.16± 24.78
Physiotherapy and Sham High-PEMF154.22± 29.54
4 weeks
GroupValue95% CI
Physiotherapy and High-PEMF152.93± 27.24
Physiotherapy and Sham High-PEMF153.00± 28.30
12 weeks
GroupValue95% CI
Physiotherapy and High-PEMF149.74± 25.48
Physiotherapy and Sham High-PEMF163.34± 27.59
Changes of Shoulder Range of Motion in Active Internal Rotation Secondary · baseline, immediately after treatment, 4 weeks, 12 weeks

Shoulder ROM during flexion, abduction in the sitting position, internal rotation (IR) at 90° of abduction of the affected shoulder were measured using a digital goniometer, and the mean of three values was used for analysis

baseline
GroupValue95% CI
Physiotherapy and High-PEMF60.75± 18.71
Physiotherapy and Sham High-PEMF73.03± 15.41
immediately
GroupValue95% CI
Physiotherapy and High-PEMF68.46± 18.68
Physiotherapy and Sham High-PEMF73.33± 14.33
4 weeks
GroupValue95% CI
Physiotherapy and High-PEMF71.19± 15.56
Physiotherapy and Sham High-PEMF80.94± 7.29
12 weeks
GroupValue95% CI
Physiotherapy and High-PEMF76.66± 12.36
Physiotherapy and Sham High-PEMF81.79± 11.29

Sponsor's own description

The aim of our study is to investigate the efficacy of high energy density pulse electromagnetic field for patients with rotator cuff tendinopathy

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of High energy density pulse electromagnetic field

Trials testing the same drug.

Other recruiting trials for Rotator Cuff Tendinosis

Currently open trials in the same condition.

Other Tri-Service General Hospital trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05483517.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing