Adhesive CapsulitisNCT06000254
High Energy Density Pulse Electromagnetic Field for Patients With Adhensive Capsulitis
A study testing High energy density pulse electromagnetic field and physiotherapy in people with Adhesive Capsulitis, 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 adhesive capsulitis Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Adhesive Capsulitis
- 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
- 13 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Feb 2024to 31 Dec 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
- Physicians diagnose frozen shoulder by considering the patient's medical background, conducting a physical assessment, and reviewing X-ray and ultrasound findings.
- The symptoms endure for a duration exceeding 3 months.
- There exists a decrease of no less than 30 degrees in a minimum of two joint angles of the affected shoulder, namely flexion, abduction, and external rotation, in comparison to the corresponding angles of the unaffected side.
Who cannot join
- Musculoskeletal ultrasound of the shoulder identifies a full-thickness tear or substantial tear in the rotator cuff tendons or presents calcific tendinitis.
- Presence of systemic rheumatic disease.
- Prior history of shoulder fracture or surgical intervention involving the shoulder joint.
- Acute compression of cervical nerve root.
- Patients displaying instability (e.g., those with signs of internal bleeding) or individuals with cancer.
- Recent receipt of shoulder injections for treatment within the last 3 months.
Show all 9Show fewer
- Impaired cognitive function that hinders the patient's ability to provide informed consent or engage in rehabilitation therapy.
- Expectant or breastfeeding women.
- Meets any of the contraindications for high-energy electromagnetic pulse therapy: individuals with organ transplants, implanted cardiac pacemakers, defibrillators, metal implants (such as stents), cochlear implants, and those requiring 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 Adhensive Capsulitis
The aim of our study is to investigate the efficacy of high energy density pulse electromagnetic field for patients with adhesive capsulitis
Read the detailed description
Adhesive capsulitis, a condition causing shoulder pain and limited range of motion (ROM), is estimated to affect 2-5% of the general population. Typically occurring in middle-aged individuals during their 50s to 70s, it presents with gradually developing shoulder pain and restricted ROM, particularly in external rotation.
In cases of primary adhesive capsulitis, the condition often resolves on its own, lasting around 18-24 months. However, some individuals experience persistent symptoms beyond 3 years, with up to 40% of patients and 15% facing lasting disability. Therefore, effective treatment is essential to alleviate the pain and disability associated with frozen shoulder.
High energy density pulse electromagnetic field (High-PEMF) differs from traditional PEMF and possesses the following characteristics:
Brief pulse duration (50μs) with a damped oscillation. Wide bandwidth (200kHz~300MHz) centered around 240kHz. High voltages (up to 40 kV) and peak currents (up to 10 kA) in the applicator spool.
Delivery of around 96Ws (Joule) of energy per pulse with a magnetic flux density of 50~100mT.
Tissue and organ penetration up to 20 cm. Although High-PEMF has shown positive results in chronic tendinopathy, there is limited evidence of its effectiveness in treating adhesive capsulitis. Therefore, our study aims to explore the efficacy and potential mechanisms underlying the use of High-PEMF in treating adhesive capsulitis patients.
- Conditions
- Adhesive Capsulitis
- Being tested
- High energy density pulse electromagnetic field, physiotherapy, sham High energy density pulse electromagnetic field
- Keywords
- adhesive capsulitis, 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 positioned over the area of the shoulder that experiences the most pain, and it remains in place for a duration of 9 minutes. The patient is subjected to a high-energy high-PEMF with a frequency of 3 pulses per second during the session.
physiotherapyOther
Physiotherapy includes a range of activities such as passive and active-assisted shoulder range of motion (ROM) exercises, Pendulum exercises, Codman's exercises, and Cross-body reach exercises. These exercises are conducted under the supervision of a physiotherapist and each training session lasts approximately 30 minutes.
sham High energy density pulse electromagnetic fieldDevice
The sham treatment coil is positioned over the area of the shoulder where maximum pain is experienced, and it remains in place for a duration of 9 minutes. The parameters are consistent with those used in the experimental group. The key distinction lies in the fact that the energy output is not delivered to the patient.
| Study group | Role | What they receive |
|---|---|---|
| physiotherapy and high-PEMF | Experimental | The patient receives physiotherapy and high-PEMF therapy twice weekly, over a period of three weeks. Receives: Device: High energy density pulse electromagnetic field; Other: physiotherapy |
| physiotherapy and sham high-PEMF | Sham comparator | The patient receives physiotherapy and sham high-PEMF therapy twice weekly, over a period 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 functionality and impairment were assessed employing the Chinese version of the Shoulder Pain and Disability Index (SPADI). This self-reported questionnaire comprises distinct pain and disability sections, yielding both domain-specific and overall scores. The SPADI encompasses five pain-related inquiries and eight disability-related questions, all pertaining to various shoulder issues encountered within the preceding week. Each item's score ranges between 0 (indicating no pain/normalcy) and 10 (reflecting maximal pain/impairment). The cumulative pain score ranges from 0 to 50, while the disability score ranges from 0 to 80. A higher score indicates a greater level of 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 posted21 Aug 2023
- Study start21 Feb 2024
- Primary completion1 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive CapsulitisStudies 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
- 13 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
- NCT06000254
- Sponsor's protocol ID
- C202305036
- Status last verified
- Dec 2024
- First submitted
- 12 Aug 2023
- Last updated
- 3 Jan 2025
- Results posted
- No
- 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 Adhensive Capsulitis
- ClinicalTrials.gov ID
- NCT06000254
- Acronym / sponsor ID
- C202305036
- Conditions
- Adhesive Capsulitis
- Keywords
- adhesive capsulitis, high energy density pulse electromagnetic field
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 21 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 adhesive capsulitis
Detailed description
Adhesive capsulitis, a condition causing shoulder pain and limited range of motion (ROM), is estimated to affect 2-5% of the general population. Typically occurring in middle-aged individuals during their 50s to 70s, it presents with gradually developing shoulder pain and restricted ROM, particularly in external rotation.
In cases of primary adhesive capsulitis, the condition often resolves on its own, lasting around 18-24 months. However, some individuals experience persistent symptoms beyond 3 years, with up to 40% of patients and 15% facing lasting disability. Therefore, effective treatment is essential to alleviate the pain and disability associated with frozen shoulder.
High energy density pulse electromagnetic field (High-PEMF) differs from traditional PEMF and possesses the following characteristics:
Brief pulse duration (50μs) with a damped oscillation. Wide bandwidth (200kHz~300MHz) centered around 240kHz. High voltages (up to 40 kV) and peak currents (up to 10 kA) in the applicator spool.
Delivery of around 96Ws (Joule) of energy per pulse with a magnetic flux density of 50~100mT.
Tissue and organ penetration up to 20 cm. Although High-PEMF has shown positive results in chronic tendinopathy, there is limited evidence of its effectiveness in treating adhesive capsulitis. Therefore, our study aims to explore the efficacy and potential mechanisms underlying the use of High-PEMF in treating adhesive capsulitis patients.
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 receives physiotherapy and high-PEMF therapy twice weekly, over a period of three weeks. |
| physiotherapy and sham high-PEMF | Sham comparator | Other: physiotherapy, Device: sham High energy density pulse electromagnetic fieldThe patient receives physiotherapy and sham high-PEMF therapy twice weekly, over a period 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)
- Physicians diagnose frozen shoulder by considering the patient's medical background, conducting a physical assessment, and reviewing X-ray and ultrasound findings.
- The symptoms endure for a duration exceeding 3 months.
- There exists a decrease of no less than 30 degrees in a minimum of two joint angles of the affected shoulder, namely flexion, abduction, and external rotation, in comparison to the corresponding angles of the unaffected side.
Key exclusion criteria (9 listed)
- Musculoskeletal ultrasound of the shoulder identifies a full-thickness tear or substantial tear in the rotator cuff tendons or presents calcific tendinitis.
- Presence of systemic rheumatic disease.
- Prior history of shoulder fracture or surgical intervention involving the shoulder joint.
- Acute compression of cervical nerve root.
- Patients displaying instability (e.g., those with signs of internal bleeding) or individuals with cancer.
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 positioned over the area of the shoulder that experiences the most pain, and it remains in place for a duration of 9 minutes. The patient is subjected to a high-energy high-PEMF with a frequency of 3 pulses per second during the session. | Device | physiotherapy and high-PEMF |
| physiotherapyPhysiotherapy includes a range of activities such as passive and active-assisted shoulder range of motion (ROM) exercises, Pendulum exercises, Codman's exercises, and Cross-body reach exercises. These exercises are conducted under the supervision of a physiotherapist and each training session lasts approximately 30 minutes. | Other | physiotherapy and high-PEMF, physiotherapy and sham high-PEMF |
| sham High energy density pulse electromagnetic fieldThe sham treatment coil is positioned over the area of the shoulder where maximum pain is experienced, and it remains in place for a duration of 9 minutes. The parameters are consistent with those used in the experimental group. The key distinction lies in the fact that the energy output is not delivered 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
Related trials for Adhesive Capsulitis
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
Active, not recruiting
Spencer vs. Ola Grimsby Techniques With Scapular Motor Training in Idiopathic Adhesive Capsulitis
Idiopathic Adhesive Capsulitis
Not yet recruitingPhase 4
OMT for Adhesive Capsulitis
Adhesive Capsulitis of the Shoulder, Frozen Shoulder
Recruiting
Maitland Mobilization With and Without Stroking Release Technique of Rotator Cuff Muscle in Frozen Shoulder
Adhesive Capsulitis
Recruiting
Comparative Effects of Niel Asher Technique and Bowen Technique on Pain, Range of Motion and Functional Disability in Patients With Adhesive Capsulitis.
Adhesive Capsulitis
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 Adhesive Capsulitis, 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: finished, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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; AzTrials last refreshed its copy on 6 Nov 2026.