Frozen ShoulderNCT05979974
High Energy Density Pulse Electromagnetic Field for Patients With Frozen Shoulder
A study testing High energy density pulse electromagnetic field and physiotherapy in people with Frozen Shoulder, 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 frozen shoulder Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- High energy density pulse electromagnetic field and physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Oct 2023to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Frozen shoulder is diagnosed by physicians based on the patient's medical history, physical examination, X-ray, and ultrasound reports.
- The symptoms persist for more than 3 months.
- There is a reduction of at least 30 degrees in at least two of the affected shoulder joint angles compared to the angles of the healthy side: shoulder flexion, abduction, and external rotation.
Who cannot join
- Shoulder musculoskeletal ultrasound reveals a full-thickness tear or massive tear of the shoulder rotator cuff tendons or calcific tendinitis.
- Systemic rheumatic disease.
- History of shoulder fracture or previous surgical treatment of the shoulder joint.
- Acute cervical nerve root compression.
- Patients with instability (e.g., those with symptoms of internal bleeding) or cancer patients.
- Received shoulder injections for treatment within the past 3 months.
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- Impaired cognitive function that prevents the patient from providing informed consent or participating in rehabilitation therapy.
- Pregnant or breastfeeding women.
- Meets any of the contraindications for high-energy electromagnetic pulse therapy: organ transplant recipients; individuals with implanted cardiac pacemakers, defibrillators, metal implants (such as stents), cochlear implants, and insulin supplementation.
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 Frozen Shoulder: 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 frozen shoulder
Read the detailed description
Frozen shoulder causes shoulder pain and limited range of motion(ROM). It is thought to afflict between 2 and 5% of the general population. Individuals of middle age are most often affected, typically during the 5th to 7th decades of life. Typical symptoms include gradual onset of shoulder pain, limited shoulder ROM at least in two or more directions (especially in external rotation). In the case of primary adhesive capsulitis, the disease is usually self-limiting, and typically lasts 18-24 months. However, persistent symptoms and movement restriction beyond 3 years have been reported in up to 40% of patients, with up to 15% of patients suffering permanent disability. Therefore, an effective treatment is necessary to treat the shoulder pain and disability caused by frozen shoulder. High energy density pulse electromagnetic field (High-PEMF), different from traditional PEMF, includes characteristics as following:
- The short pulse duration (50μs) with a damped oscillation
- The broad bandwidth(200kHz~300MHz) with a basic frequency 240kHz
- High voltages (up to 40 kV) and peak currents (up to 10 kA) arise in the applicator spool
- Delivery of energy per pulse of about 96Ws (Joule) with a magnetic flux density of 50~100mT
- Depth penetration for tissue and organ up to 20 cm
It has been applied in chronic tendinopathy with positive outcomes. However, few studies support its application in the setting of frozen shoulder. Hence, the aim of our study is to investigate the efficacy and the underlying possible mechanism of High-PEMF for patients with frozen shoulder.
- Conditions
- Frozen Shoulder
- Being tested
- High energy density pulse electromagnetic field, physiotherapy, sham High energy density pulse electromagnetic field
- Keywords
- Frozen Shoulder, high energy density pulse electromagnetic field
- Medical subject headings
- Bursitis
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 high energy of high-PEMF with a rate of 3 pulse per second is applied to the patient.
physiotherapyOther
Physiotherapy such as shoulder passive and active-assisted range of motion (ROM) exercises, Pendulum exercises, Codman's exercises and Cross-body reach exercises. Under the physiotherapist's guidance, the patient receives the training session about 30 minutes every time.
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(high energy, a rate of 3 pulse per second) with the difference that the energy output doesn't export to the patient.
| Study group | Role | What they receive |
|---|---|---|
| physiotherapy and high-PEMF | Experimental | The patient undergoes physiotherapy and high-PEMF therapy twice a week, for a duration of three weeks. Receives: Device: High energy density pulse electromagnetic field; Other: physiotherapy |
| physiotherapy and sham high-PEMF | Sham comparator | The patient undergoes physiotherapy and sham high-PEMF therapy twice a week, for a duration of three weeks. Receives: Other: physiotherapy; Device: sham High energy density pulse electromagnetic field |
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 analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. "0" means painless and "10" means extremely painful.
Measured: the change from baseline, post-intervention immediately, post-intervention 1, 3, 6 months
Secondary outcomes (1)
Change in Shoulder Pain and Disability Index (SPADI)
Shoulder function and disability were evaluated using the Chinese version of the Shoulder Pain and Disability Index (SPADI), a self-report questionnaire that yields pain and disability domain and total scores. The SPADI includes five questions on pain and eight questions on disability, referring to various problems with the shoulder encountered over the preceding week. Each item's score ranges from 0 (no pain/normal) to 10 (maximal pain/disability), with total scores of pain from 0-50 and disability from to 0-80. A higher score shows more disability.
Measured: the change from baseline, post-intervention immediately, post-intervention 1, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start31 Oct 2023
- Primary completion15 Oct 2024
- Study completion30 Nov 2024
Why it stopped: Unable to find participants willing to join the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies 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
- 17 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 Chiang, MD, MS, Principal investigator, Department of Physical Medicine and Rehabilitation, Tri-Service General
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979974
- Sponsor's protocol ID
- A202305106
- Status last verified
- Dec 2024
- First submitted
- 30 Jul 2023
- Last updated
- 3 Jan 2025
- Results posted
- No
- 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 3 Jan 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 Frozen Shoulder: A Double-blinded, Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT05979974
- Acronym / sponsor ID
- A202305106
- Conditions
- Frozen Shoulder
- Keywords
- Frozen Shoulder, high energy density pulse electromagnetic field
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to find participants willing to join the trial.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
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 frozen shoulder
Detailed description
Frozen shoulder causes shoulder pain and limited range of motion(ROM). It is thought to afflict between 2 and 5% of the general population. Individuals of middle age are most often affected, typically during the 5th to 7th decades of life. Typical symptoms include gradual onset of shoulder pain, limited shoulder ROM at least in two or more directions (especially in external rotation). In the case of primary adhesive capsulitis, the disease is usually self-limiting, and typically lasts 18-24 months. However, persistent symptoms and movement restriction beyond 3 years have been reported in up to 40% of patients, with up to 15% of patients suffering permanent disability. Therefore, an effective treatment is necessary to treat the shoulder pain and disability caused by frozen shoulder. High energy density pulse electromagnetic field (High-PEMF), different from traditional PEMF, includes characteristics as following:
- The short pulse duration (50μs) with a damped oscillation
- The broad bandwidth(200kHz~300MHz) with a basic frequency 240kHz
- High voltages (up to 40 kV) and peak currents (up to 10 kA) arise in the applicator spool
- Delivery of energy per pulse of about 96Ws (Joule) with a magnetic flux density of 50~100mT
- Depth penetration for tissue and organ up to 20 cm
It has been applied in chronic tendinopathy with positive outcomes. However, few studies support its application in the setting of frozen shoulder. Hence, the aim of our study is to investigate the efficacy and the underlying possible mechanism of High-PEMF for patients with frozen shoulder.
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, Other: physiotherapyThe patient undergoes physiotherapy and high-PEMF therapy twice a week, for a duration of three weeks. |
| physiotherapy and sham high-PEMF | Sham comparator | Other: physiotherapy, Device: sham High energy density pulse electromagnetic fieldThe patient undergoes physiotherapy and sham high-PEMF therapy twice a week, for a duration of three weeks. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Frozen shoulder is diagnosed by physicians based on the patient's medical history, physical examination, X-ray, and ultrasound reports.
- The symptoms persist for more than 3 months.
- There is a reduction of at least 30 degrees in at least two of the affected shoulder joint angles compared to the angles of the healthy side: shoulder flexion, abduction, and external rotation.
Key exclusion criteria (9 listed)
- Shoulder musculoskeletal ultrasound reveals a full-thickness tear or massive tear of the shoulder rotator cuff tendons or calcific tendinitis.
- Systemic rheumatic disease.
- History of shoulder fracture or previous surgical treatment of the shoulder joint.
- Acute cervical nerve root compression.
- Patients with instability (e.g., those with symptoms of internal bleeding) or cancer patients.
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 high energy of high-PEMF with a rate of 3 pulse per second is applied to the patient. | Device | physiotherapy and high-PEMF |
| physiotherapyPhysiotherapy such as shoulder passive and active-assisted range of motion (ROM) exercises, Pendulum exercises, Codman's exercises and Cross-body reach exercises. Under the physiotherapist's guidance, the patient receives the training session about 30 minutes every time. | Other | physiotherapy and high-PEMF, physiotherapy and sham 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(high energy, a rate of 3 pulse per second) with the difference that the energy output doesn't export to the patient. | Device | physiotherapy and sham high-PEMF |
Primary outcome
Change in pain Visual Analogue Scale(VAS)
Time frame: the change from baseline, post-intervention immediately, post-intervention 1, 3, 6 months
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.
1 secondary outcome
Change in Shoulder Pain and Disability Index (SPADI)
Time frame: the change from baseline, post-intervention immediately, post-intervention 1, 3, 6 months
Results and safety
The study was stopped early (reason given: Unable to find participants willing to join the trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
Related trials for Frozen Shoulder
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Effects of Clinic Versus mHealth Application-Based Shoulder Rehabilitation in Patients With Adhesive Capsulitis
Adhesive Capsulitis
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Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
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Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
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Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
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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 Chiang, 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 Frozen Shoulder, 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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 3 Jan 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?
The study was stopped early (reason given: Unable to find participants willing to join the trial.). Results are not available in the source record.
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: the change from baseline, post-intervention immediately, post-intervention 1, 3, 6 months). 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 3 Jan 2025.