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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of High Energy Density Pulse Electromagnetic Field for Patients With Rotator Cuff Tendinopathy: A Double-blinded, Randomized Controlled Trail

Conditions
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Rotator Cuff Tendinosis

Intervention / Treatment
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* Device: High energy density pulse electromagnetic field
* Device: sham High energy density pulse electromagnetic field
* Behavioral: physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: physiotherapy and high-PEMF<br>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<br>* 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.<br>Behavioral: physiotherapy<br>* 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.<br>|
| Sham Comparator: physiotherapy and sham high-PEMF<br>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<br>* 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.<br>Behavioral: physiotherapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 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.A higher score shows more disability. | the change from baseline, post-intervention immediately, post-intervention 1, 3, 6 months | 
| Blood test | Perform blood test to analysis the change of interleukin-1β, interleukin-6, interleukin-10 | change from baseline to 1 month | 
| Blood test | Perform blood test to analysis the change of transforming growth factor-β(TGF-β) | change from baseline to 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rotator cuff tendinopathy, high energy density pulse electromagnetic field