Trial Outcomes & Findings for High Energy Density Pulse Electromagnetic Field for Patients With Rotator Cuff Tendinopathy (NCT NCT05483517)
NCT ID: NCT05483517
Last Updated: 2025-02-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
baseline, immediate after treatment, 4 weeks, 12 weeks
Results posted on
2025-02-25
Participant Flow
Participant milestones
| Measure |
Physiotherapy and High-PEMF
The patient receives physiotherapy under the physiotherapist's guidance and high-PEMF therapy for three weeks, following two sessions a week.
High energy density pulse electromagnetic field: 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: 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 Sham High-PEMF
The patient receives physiotherapy under the physiotherapist's guidance and sham high-PEMF therapy for three weeks, following two sessions a week.
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(normal energy, a rate of 2 pulse per second) with the difference that the energy output doesn't export to the patient.
physiotherapy: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Physiotherapy and High-PEMF
n=11 Participants
The patient receives physiotherapy under the physiotherapist's guidance and high-PEMF therapy for three weeks, following two sessions a week.
High energy density pulse electromagnetic field: 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: 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 Sham High-PEMF
n=10 Participants
The patient receives physiotherapy under the physiotherapist's guidance and sham high-PEMF therapy for three weeks, following two sessions a week.
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(normal energy, a rate of 2 pulse per second) with the difference that the energy output doesn't export to the patient.
physiotherapy: 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.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
age
|
62.73 years
STANDARD_DEVIATION 7.51 • n=11 Participants
|
56.10 years
STANDARD_DEVIATION 10.55 • n=10 Participants
|
59.57 years
STANDARD_DEVIATION 9.47 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=11 Participants
|
6 Participants
n=10 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=11 Participants
|
4 Participants
n=10 Participants
|
10 Participants
n=21 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Taiwan
|
11 participants
n=11 Participants
|
10 participants
n=10 Participants
|
21 participants
n=21 Participants
|
|
BMI (kg/m2)
|
23.49 kg/m2
STANDARD_DEVIATION 2.11 • n=11 Participants
|
23.47 kg/m2
STANDARD_DEVIATION 2.01 • n=10 Participants
|
23.48 kg/m2
STANDARD_DEVIATION 2.01 • n=21 Participants
|
|
Duration (weeks)
|
13.91 weeks
STANDARD_DEVIATION 3.70 • n=11 Participants
|
19.80 weeks
STANDARD_DEVIATION 14.91 • n=10 Participants
|
16.71 weeks
STANDARD_DEVIATION 10.77 • n=21 Participants
|
PRIMARY outcome
Timeframe: baseline, immediate after treatment, 4 weeks, 12 weeksThe 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.
Outcome measures
| Measure |
Physiotherapy and High-PEMF
n=11 Participants
The patient receives physiotherapy under the physiotherapist's guidance and high-PEMF therapy for three weeks, following two sessions a week.
High energy density pulse electromagnetic field: 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: 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 Sham High-PEMF
n=10 Participants
The patient receives physiotherapy under the physiotherapist's guidance and sham high-PEMF therapy for three weeks, following two sessions a week.
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(normal energy, a rate of 2 pulse per second) with the difference that the energy output doesn't export to the patient.
physiotherapy: 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.
|
|---|---|---|
|
Change in Pain Visual Analogue Scale(VAS)
4 weeks
|
3.55 score on a scale
Standard Deviation 1.69
|
4.90 score on a scale
Standard Deviation 1.52
|
|
Change in Pain Visual Analogue Scale(VAS)
baseline
|
5.91 score on a scale
Standard Deviation 2.51
|
5.90 score on a scale
Standard Deviation 1.91
|
|
Change in Pain Visual Analogue Scale(VAS)
immediate after treatment
|
4.73 score on a scale
Standard Deviation 2.37
|
4.60 score on a scale
Standard Deviation 2.27
|
|
Change in Pain Visual Analogue Scale(VAS)
12 weeks
|
3.72 score on a scale
Standard Deviation 2.61
|
3.50 score on a scale
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: baseline, immediate after treatment, 4 weeks, 12 weeksThe 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 Disability subscales, with a range from 0 to 130. A higher total score indicates greater pain and disability.
Outcome measures
| Measure |
Physiotherapy and High-PEMF
n=11 Participants
The patient receives physiotherapy under the physiotherapist's guidance and high-PEMF therapy for three weeks, following two sessions a week.
High energy density pulse electromagnetic field: 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: 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 Sham High-PEMF
n=10 Participants
The patient receives physiotherapy under the physiotherapist's guidance and sham high-PEMF therapy for three weeks, following two sessions a week.
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(normal energy, a rate of 2 pulse per second) with the difference that the energy output doesn't export to the patient.
physiotherapy: 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.
|
|---|---|---|
|
Change in Total Score of Shoulder Pain and Disability Index (SPADI)
baseline
|
58.27 score on a scale
Standard Deviation 22.85
|
65.80 score on a scale
Standard Deviation 32.25
|
|
Change in Total Score of Shoulder Pain and Disability Index (SPADI)
immediate after treatment
|
39.18 score on a scale
Standard Deviation 25.13
|
52.40 score on a scale
Standard Deviation 26.83
|
|
Change in Total Score of Shoulder Pain and Disability Index (SPADI)
4 weeks
|
41.27 score on a scale
Standard Deviation 30.21
|
60.20 score on a scale
Standard Deviation 41.16
|
|
Change in Total Score of Shoulder Pain and Disability Index (SPADI)
12 weeks
|
33.27 score on a scale
Standard Deviation 21.28
|
30.80 score on a scale
Standard Deviation 33.27
|
SECONDARY outcome
Timeframe: baseline, immediate after treatment, 4 weeks, 12 weeksShoulder 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
Outcome measures
| Measure |
Physiotherapy and High-PEMF
n=11 Participants
The patient receives physiotherapy under the physiotherapist's guidance and high-PEMF therapy for three weeks, following two sessions a week.
High energy density pulse electromagnetic field: 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: 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 Sham High-PEMF
n=10 Participants
The patient receives physiotherapy under the physiotherapist's guidance and sham high-PEMF therapy for three weeks, following two sessions a week.
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(normal energy, a rate of 2 pulse per second) with the difference that the energy output doesn't export to the patient.
physiotherapy: 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.
|
|---|---|---|
|
Changes of Shoulder Range of Motion in Active Flexion
baseline
|
143.74 degree
Standard Deviation 20.18
|
154.11 degree
Standard Deviation 23.47
|
|
Changes of Shoulder Range of Motion in Active Flexion
immediately
|
147.76 degree
Standard Deviation 19.81
|
152.53 degree
Standard Deviation 24.93
|
|
Changes of Shoulder Range of Motion in Active Flexion
4 weeks
|
144.89 degree
Standard Deviation 21.66
|
149.79 degree
Standard Deviation 24.70
|
|
Changes of Shoulder Range of Motion in Active Flexion
12 weeks
|
148.25 degree
Standard Deviation 22.54
|
159.29 degree
Standard Deviation 25.29
|
SECONDARY outcome
Timeframe: baseline, immediately after treatment, 4 weeks, 12 weeksShoulder 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
Outcome measures
| Measure |
Physiotherapy and High-PEMF
n=11 Participants
The patient receives physiotherapy under the physiotherapist's guidance and high-PEMF therapy for three weeks, following two sessions a week.
High energy density pulse electromagnetic field: 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: 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 Sham High-PEMF
n=10 Participants
The patient receives physiotherapy under the physiotherapist's guidance and sham high-PEMF therapy for three weeks, following two sessions a week.
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(normal energy, a rate of 2 pulse per second) with the difference that the energy output doesn't export to the patient.
physiotherapy: 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.
|
|---|---|---|
|
Changes of Shoulder Range of Motion in Active Abduction
baseline
|
142.51 degree
Standard Deviation 24.13
|
153.79 degree
Standard Deviation 26.34
|
|
Changes of Shoulder Range of Motion in Active Abduction
immediately
|
147.16 degree
Standard Deviation 24.78
|
154.22 degree
Standard Deviation 29.54
|
|
Changes of Shoulder Range of Motion in Active Abduction
4 weeks
|
152.93 degree
Standard Deviation 27.24
|
153.00 degree
Standard Deviation 28.30
|
|
Changes of Shoulder Range of Motion in Active Abduction
12 weeks
|
149.74 degree
Standard Deviation 25.48
|
163.34 degree
Standard Deviation 27.59
|
SECONDARY outcome
Timeframe: baseline, immediately after treatment, 4 weeks, 12 weeksShoulder 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
Outcome measures
| Measure |
Physiotherapy and High-PEMF
n=11 Participants
The patient receives physiotherapy under the physiotherapist's guidance and high-PEMF therapy for three weeks, following two sessions a week.
High energy density pulse electromagnetic field: 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: 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 Sham High-PEMF
n=10 Participants
The patient receives physiotherapy under the physiotherapist's guidance and sham high-PEMF therapy for three weeks, following two sessions a week.
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(normal energy, a rate of 2 pulse per second) with the difference that the energy output doesn't export to the patient.
physiotherapy: 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.
|
|---|---|---|
|
Changes of Shoulder Range of Motion in Active Internal Rotation
baseline
|
60.75 degree
Standard Deviation 18.71
|
73.03 degree
Standard Deviation 15.41
|
|
Changes of Shoulder Range of Motion in Active Internal Rotation
immediately
|
68.46 degree
Standard Deviation 18.68
|
73.33 degree
Standard Deviation 14.33
|
|
Changes of Shoulder Range of Motion in Active Internal Rotation
4 weeks
|
71.19 degree
Standard Deviation 15.56
|
80.94 degree
Standard Deviation 7.29
|
|
Changes of Shoulder Range of Motion in Active Internal Rotation
12 weeks
|
76.66 degree
Standard Deviation 12.36
|
81.79 degree
Standard Deviation 11.29
|
Adverse Events
Physiotherapy and High-PEMF
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Physiotherapy and Sham High-PEMF
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place