Rotator Cuff TendinosisNCT05483517
High Energy Density Pulse Electromagnetic Field for Patients With Rotator Cuff Tendinopathy
A study testing High energy density pulse electromagnetic field and physiotherapy in people with Rotator Cuff Tendinosis, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
The aim of our study is to investigate the efficacy of high energy density pulse electromagnetic field for patients with rotator cuff tendinopathy Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Rotator Cuff Tendinosis
- What is being tested?
- High energy density pulse electromagnetic field and physiotherapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Jan 2023to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of High Energy Density Pulse Electromagnetic Field for Patients With Rotator Cuff Tendinopathy: A Double-blinded, Randomized Controlled Trail
The aim of our study is to investigate the efficacy of high energy density pulse electromagnetic field for patients with rotator cuff tendinopathy
Read the 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.
- Conditions
- Rotator Cuff Tendinosis
- Being tested
- High energy density pulse electromagnetic field, sham High energy density pulse electromagnetic field, physiotherapy
- Keywords
- rotator cuff tendinopathy, high energy density pulse electromagnetic field
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High energy density pulse electromagnetic fieldDevice
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.
sham High energy density pulse electromagnetic fieldDevice
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.
physiotherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: sham High energy density pulse electromagnetic field; Behavioral: physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, immediate after treatment, 4 weeks, 12 weeks
Secondary outcomes (4)
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.
Measured: baseline, immediate after treatment, 4 weeks, 12 weeks
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
Measured: baseline, immediate after treatment, 4 weeks, 12 weeks
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
Measured: baseline, immediately after treatment, 4 weeks, 12 weeks
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
Measured: baseline, immediately after treatment, 4 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start31 Jan 2023
- Primary completion8 Apr 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rotator Cuff TendinosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang-Cheng Chen, Tri-Service General Hospital (TSGH)
- Investigators
- Liang cheng Chen, MD, MS, Principal investigator, Department of Physical Medicine and Rehabilitation, Tri-Service General
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483517
- Sponsor's protocol ID
- A202205076
- Status last verified
- Feb 2025
- First submitted
- 29 Jul 2022
- Last updated
- 25 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High Energy Density Pulse Electromagnetic Field for Patients With Rotator Cuff Tendinopathy: A Double-blinded, Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT05483517
- Acronym / sponsor ID
- A202205076
- Conditions
- Rotator Cuff Tendinosis
- Keywords
- rotator cuff tendinopathy, high energy density pulse electromagnetic field
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 8 Apr 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 2 Aug 2022 (actual)
- Results
- Posted 25 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physiotherapy and high-PEMF | Experimental | Device: High energy density pulse electromagnetic field, Behavioral: physiotherapyThe patient receives physiotherapy under the physiotherapist's guidance and high-PEMF therapy for three weeks, following two sessions a week. |
| physiotherapy and sham high-PEMF | Sham comparator | Device: sham High energy density pulse electromagnetic field, Behavioral: physiotherapyThe patient receives physiotherapy under the physiotherapist's guidance and sham high-PEMF therapy for three weeks, following two sessions a week. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High energy density pulse electromagnetic fieldThe 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. | Device | physiotherapy and high-PEMF |
| sham High energy density pulse electromagnetic fieldThe 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. | Device | physiotherapy and sham high-PEMF |
| physiotherapyPhysiotherapy 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. | Behavioural | physiotherapy and high-PEMF, physiotherapy and sham high-PEMF |
Primary outcome
Change in Pain Visual Analogue Scale(VAS)
Time frame: 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.
4 secondary outcomes
Change in Total Score of Shoulder Pain and Disability Index (SPADI)
Time frame: baseline, immediate after treatment, 4 weeks, 12 weeks
Changes of Shoulder Range of Motion in Active Flexion
Time frame: baseline, immediate after treatment, 4 weeks, 12 weeks
Changes of Shoulder Range of Motion in Active Abduction
Time frame: baseline, immediately after treatment, 4 weeks, 12 weeks
Changes of Shoulder Range of Motion in Active Internal Rotation
Time frame: baseline, immediately after treatment, 4 weeks, 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Rotator Cuff Tendinosis
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Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome - Outcomes and Mechanisms
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liang cheng Chen, MD, MS principal investigator
Department of Physical Medicine and Rehabilitation, Tri-Service General
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High energy density pulse electromagnetic field and physiotherapy in people with Rotator Cuff Tendinosis, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Visual Analogue Scale(VAS) (time frame: baseline, immediate after treatment, 4 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.