Rotator Cuff Tendinosis
Conditions
Keywords
rotator cuff tendinopathy, high energy density pulse electromagnetic field
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
Detailed description
Traditional pulse electromagnetic field (PEMF) devices have been approved by the U.S. Food and Drug Administration (FDA) to treat nonunion fractures and cleared to treat post-operative pain and edema, osteoarthritis, and plantar fasciitis. However, high level of evidence indicated that the lack of beneficial effects of PEMF on pain, function or range of motion in the treatment of shoulder pain. High energy density pulse electromagnetic field(High-PEMF) which builds up a voltage up to 30 kilovolt (kV) with shorter impulse time(50us) and broad band-width(200kHz\ 300MHz) is very different from traditional PEMF. Magnetic field about 50\ 150 millitesla (mT) is created and it can penetrate the body up to 20 cm. The aim of our study is to investigate the efficacy of High-PEMF for patients with rotator cuff tendinopathy.
Interventions
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.
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.
BEHAVIORALphysiotherapy
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.
Sponsors
Tri-Service General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. age between 20 to 75 years old 2. persistent shoulder pain for at least 3 months and pain VAS score \>=5 3. positive result in any of the following physical examinations: Hawkins-Kennedy, Neer or Jobe tests 4. confirmed rotator cuff tendinopathy by ultrasonography or MRI
Exclusion criteria
1. complete or full-thickness tear of rotator cuff found by ultrasonography or MRI 2. previous shoulder surgery 3. previous history of severe trauma in shoulder 4. cervical radiculopathy related shoulder pain or referred pain 5. other shoulder diseases: adhesive capsulitis, calcifying tendinopathy, radiology-confirmed acromion type III, shoulder instability, degenerative osteoarthritis, labral tear 6. present with any of the following systemic diseases: active infection, sever and uncontrolled medical condition, cancer, immune-related or rheumatoid arthritis, hyperuricemia and gout 7. previous treatment with articular or subacromial steroid injections within the last 3 months 8. cognitive impairment with loss of ability to sign the agreement and receive rehabilitation 9. pregnancy or lactating women 10. has any of the following contraindications: Carriers of pacemakers, internal defibrillators,internal metal implants (locally dependent), Cochlea implants, metallic stents, insulin pumps
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Visual Analogue Scale(VAS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Score of Shoulder Pain and Disability Index (SPADI) | 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 Disability subscales, with a range from 0 to 130. A higher total score indicates greater pain and disability. |
| Changes of Shoulder Range of Motion in Active Flexion | 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 |
| Changes of Shoulder Range of Motion in Active Abduction | 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 |
| Changes of Shoulder Range of Motion in Active Internal Rotation | 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 |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| 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. | 10 |
| Total | 21 |
Baseline characteristics
| Characteristic | Physiotherapy and Sham High-PEMF | Total | Physiotherapy and High-PEMF |
|---|---|---|---|
| Age, Continuous age | 56.10 years STANDARD_DEVIATION 10.55 | 59.57 years STANDARD_DEVIATION 9.47 | 62.73 years STANDARD_DEVIATION 7.51 |
| BMI (kg/m2) | 23.47 kg/m2 STANDARD_DEVIATION 2.01 | 23.48 kg/m2 STANDARD_DEVIATION 2.01 | 23.49 kg/m2 STANDARD_DEVIATION 2.11 |
| Duration (weeks) | 19.80 weeks STANDARD_DEVIATION 14.91 | 16.71 weeks STANDARD_DEVIATION 10.77 | 13.91 weeks STANDARD_DEVIATION 3.7 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Taiwan | 10 participants | 21 participants | 11 participants |
| Sex: Female, Male Female | 6 Participants | 11 Participants | 5 Participants |
| Sex: Female, Male Male | 4 Participants | 10 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 10 |
| other Total, other adverse events | 0 / 11 | 0 / 10 |
| serious Total, serious adverse events | 0 / 11 | 0 / 10 |
Outcome results
Primary
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.
Time frame: baseline, immediate after treatment, 4 weeks, 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Physiotherapy and High-PEMF | Change in Pain Visual Analogue Scale(VAS) | baseline | 5.91 score on a scale | Standard Deviation 2.51 |
| Physiotherapy and High-PEMF | Change in Pain Visual Analogue Scale(VAS) | immediate after treatment | 4.73 score on a scale | Standard Deviation 2.37 |
| Physiotherapy and High-PEMF | Change in Pain Visual Analogue Scale(VAS) | 4 weeks | 3.55 score on a scale | Standard Deviation 1.69 |
| Physiotherapy and High-PEMF | Change in Pain Visual Analogue Scale(VAS) | 12 weeks | 3.72 score on a scale | Standard Deviation 2.61 |
| Physiotherapy and Sham High-PEMF | Change in Pain Visual Analogue Scale(VAS) | 12 weeks | 3.50 score on a scale | Standard Deviation 1.27 |
| Physiotherapy and Sham High-PEMF | Change in Pain Visual Analogue Scale(VAS) | baseline | 5.90 score on a scale | Standard Deviation 1.91 |
| Physiotherapy and Sham High-PEMF | Change in Pain Visual Analogue Scale(VAS) | 4 weeks | 4.90 score on a scale | Standard Deviation 1.52 |
| Physiotherapy and Sham High-PEMF | Change in Pain Visual Analogue Scale(VAS) | immediate after treatment | 4.60 score on a scale | Standard Deviation 2.27 |
Secondary
Change in Total Score of Shoulder Pain and Disability Index (SPADI)
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 Disability subscales, with a range from 0 to 130. A higher total score indicates greater pain and disability.
Time frame: baseline, immediate after treatment, 4 weeks, 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Physiotherapy and High-PEMF | Change in Total Score of Shoulder Pain and Disability Index (SPADI) | baseline | 58.27 score on a scale | Standard Deviation 22.85 |
| Physiotherapy and High-PEMF | Change in Total Score of Shoulder Pain and Disability Index (SPADI) | immediate after treatment | 39.18 score on a scale | Standard Deviation 25.13 |
| Physiotherapy and High-PEMF | Change in Total Score of Shoulder Pain and Disability Index (SPADI) | 4 weeks | 41.27 score on a scale | Standard Deviation 30.21 |
| Physiotherapy and High-PEMF | Change in Total Score of Shoulder Pain and Disability Index (SPADI) | 12 weeks | 33.27 score on a scale | Standard Deviation 21.28 |
| Physiotherapy and Sham High-PEMF | Change in Total Score of Shoulder Pain and Disability Index (SPADI) | 12 weeks | 30.80 score on a scale | Standard Deviation 33.27 |
| Physiotherapy and Sham High-PEMF | Change in Total Score of Shoulder Pain and Disability Index (SPADI) | baseline | 65.80 score on a scale | Standard Deviation 32.25 |
| Physiotherapy and Sham High-PEMF | Change in Total Score of Shoulder Pain and Disability Index (SPADI) | 4 weeks | 60.20 score on a scale | Standard Deviation 41.16 |
| Physiotherapy and Sham High-PEMF | Change in Total Score of Shoulder Pain and Disability Index (SPADI) | immediate after treatment | 52.40 score on a scale | Standard Deviation 26.83 |
Secondary
Changes of Shoulder Range of Motion in Active Abduction
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
Time frame: baseline, immediately after treatment, 4 weeks, 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Physiotherapy and High-PEMF | Changes of Shoulder Range of Motion in Active Abduction | baseline | 142.51 degree | Standard Deviation 24.13 |
| Physiotherapy and High-PEMF | Changes of Shoulder Range of Motion in Active Abduction | immediately | 147.16 degree | Standard Deviation 24.78 |
| Physiotherapy and High-PEMF | Changes of Shoulder Range of Motion in Active Abduction | 4 weeks | 152.93 degree | Standard Deviation 27.24 |
| Physiotherapy and High-PEMF | Changes of Shoulder Range of Motion in Active Abduction | 12 weeks | 149.74 degree | Standard Deviation 25.48 |
| Physiotherapy and Sham High-PEMF | Changes of Shoulder Range of Motion in Active Abduction | 12 weeks | 163.34 degree | Standard Deviation 27.59 |
| Physiotherapy and Sham High-PEMF | Changes of Shoulder Range of Motion in Active Abduction | baseline | 153.79 degree | Standard Deviation 26.34 |
| Physiotherapy and Sham High-PEMF | Changes of Shoulder Range of Motion in Active Abduction | 4 weeks | 153.00 degree | Standard Deviation 28.3 |
| Physiotherapy and Sham High-PEMF | Changes of Shoulder Range of Motion in Active Abduction | immediately | 154.22 degree | Standard Deviation 29.54 |
Secondary
Changes of Shoulder Range of Motion in Active Flexion
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
Time frame: baseline, immediate after treatment, 4 weeks, 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Physiotherapy and High-PEMF | Changes of Shoulder Range of Motion in Active Flexion | immediately | 147.76 degree | Standard Deviation 19.81 |
| Physiotherapy and High-PEMF | Changes of Shoulder Range of Motion in Active Flexion | baseline | 143.74 degree | Standard Deviation 20.18 |
| Physiotherapy and High-PEMF | Changes of Shoulder Range of Motion in Active Flexion | 12 weeks | 148.25 degree | Standard Deviation 22.54 |
| Physiotherapy and High-PEMF | Changes of Shoulder Range of Motion in Active Flexion | 4 weeks | 144.89 degree | Standard Deviation 21.66 |
| Physiotherapy and Sham High-PEMF | Changes of Shoulder Range of Motion in Active Flexion | 12 weeks | 159.29 degree | Standard Deviation 25.29 |
| Physiotherapy and Sham High-PEMF | Changes of Shoulder Range of Motion in Active Flexion | baseline | 154.11 degree | Standard Deviation 23.47 |
| Physiotherapy and Sham High-PEMF | Changes of Shoulder Range of Motion in Active Flexion | 4 weeks | 149.79 degree | Standard Deviation 24.7 |
| Physiotherapy and Sham High-PEMF | Changes of Shoulder Range of Motion in Active Flexion | immediately | 152.53 degree | Standard Deviation 24.93 |
Secondary
Changes of Shoulder Range of Motion in Active Internal Rotation
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
Time frame: baseline, immediately after treatment, 4 weeks, 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Physiotherapy and High-PEMF | Changes of Shoulder Range of Motion in Active Internal Rotation | baseline | 60.75 degree | Standard Deviation 18.71 |
| Physiotherapy and High-PEMF | Changes of Shoulder Range of Motion in Active Internal Rotation | immediately | 68.46 degree | Standard Deviation 18.68 |
| Physiotherapy and High-PEMF | Changes of Shoulder Range of Motion in Active Internal Rotation | 4 weeks | 71.19 degree | Standard Deviation 15.56 |
| Physiotherapy and High-PEMF | Changes of Shoulder Range of Motion in Active Internal Rotation | 12 weeks | 76.66 degree | Standard Deviation 12.36 |
| Physiotherapy and Sham High-PEMF | Changes of Shoulder Range of Motion in Active Internal Rotation | 12 weeks | 81.79 degree | Standard Deviation 11.29 |
| Physiotherapy and Sham High-PEMF | Changes of Shoulder Range of Motion in Active Internal Rotation | baseline | 73.03 degree | Standard Deviation 15.41 |
| Physiotherapy and Sham High-PEMF | Changes of Shoulder Range of Motion in Active Internal Rotation | 4 weeks | 80.94 degree | Standard Deviation 7.29 |
| Physiotherapy and Sham High-PEMF | Changes of Shoulder Range of Motion in Active Internal Rotation | immediately | 73.33 degree | Standard Deviation 14.33 |