Hemiplegic Shoulder PainNCT07912138
Effectiveness of High-intensity Peripheral Magnetic Stimulation on Hemiplegic Shoulder Pain After Stroke
A study testing Active Peripheral Magnetic Stimulation in people with Hemiplegic Shoulder Pain, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital.
Trial summary
This study aims to investigate the effectiveness of high-intensity electromagnetic stimulation using the BTL-6000 Super Inductive System (SIS) in the management of hemiplegic shoulder pain in patients with stroke. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemiplegic Shoulder Pain
- What is being tested?
- Active Peripheral Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-75 years.
- History of a first-ever unilateral stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI), occurring more than 3 months before enrollment.
- Hemiplegic shoulder pain with a Visual Analog Scale (VAS) score of at least 4.
- Presence of shoulder pathology identified by clinical examination and ultrasonography.
- Reduced shoulder range of motion.
- Brunnstrom recovery stage of at least 2.
Show all 9Show fewer
- Clinically stable condition.
- Mini-Mental State Examination (MMSE) score of at least 18.
- Ability to provide written informed consent.
Who cannot join
- Shoulder pain or restricted shoulder movement before the stroke.
- History of shoulder trauma, infection, malignancy, or surgery.
- Full-thickness rotator cuff tear.
- Shoulder injection within the previous 3 months.
- Previous treatment with high-intensity laser therapy, electromagnetic stimulation, or therapeutic ultrasound.
- Central post-stroke pain or complex regional pain syndrome.
Show all 13Show fewer
- Modified Ashworth Scale (MAS) score of 3 or higher.
- Cervical radiculopathy or another neurological disorder.
- Inflammatory rheumatic disease.
- Uncontrolled diabetes mellitus (HbA1c of 8% or higher or poor glycemic regulation within the previous 3 months).
- Pacemaker, implanted electronic device, or metallic implant contraindicating electromagnetic stimulation.
- Pregnancy.
- Severe aphasia or severe visual or hearing impairment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of High-intensity Peripheral Magnetic Mtimulation in Patients With Post-stroke Hemiplegic Shoulder Pain
This study aims to investigate the effectiveness of high-intensity electromagnetic stimulation using the BTL-6000 Super Inductive System (SIS) in the management of hemiplegic shoulder pain in patients with stroke. Hemiplegic shoulder pain is a common complication following stroke and may negatively affect upper limb function, participation in rehabilitation, and quality of life. The study will evaluate whether treatment with the Super Inductive System can reduce shoulder pain and improve shoulder-related clinical outcomes. The findings are expected to contribute to the evidence regarding non-invasive physical therapy approaches for hemiplegic shoulder pain.
- Conditions
- Hemiplegic Shoulder Pain
- Being tested
- Active Peripheral Magnetic Stimulation, Sham Peripheral Magnetic Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Peripheral Magnetic StimulationDevice
Participants in the active intervention group will receive active peripheral magnetic stimulation for hemiplegic shoulder pain following stroke. Treatment will be administered using the study device by trained healthcare professionals according to the predefined treatment protocol.
Sham Peripheral Magnetic StimulationDevice
Participants in the sham comparator group will receive sham peripheral magnetic stimulation for hemiplegic shoulder pain following stroke. The sham procedure will be designed to mimic the active intervention without delivering therapeutic magnetic stimulation. The treatment schedule and assessment procedures will be consistent with those of the active stimulation group.
| Study group | Role | What they receive |
|---|---|---|
| Active Peripheral Magnetic Stimulation | Experimental | Participants assigned to this group will receive active peripheral magnetic stimulation according to the predefined treatment protocol. The intervention will be administered using the study device under the supervision of trained healthcare professionals. Receives: Device: Active Peripheral Magnetic Stimulation |
| Sham Peripheral Magnetic Stimulation | Sham comparator | Participants assigned to this group will receive sham peripheral magnetic stimulation using a procedure designed to mimic the active intervention without delivering the intended therapeutic magnetic stimulation. The intervention schedule and assessment procedures will be consistent with those of the active stimulation group. Receives: Device: Sham Peripheral Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) for Shoulder Pain
Shoulder pain will be assessed using the Visual Analog Scale (VAS). Patients will be asked to rate their average shoulder pain experienced at rest and during shoulder movements over the previous 24 hours on a scale from 0 (no pain) to 10 (unbearable pain).
Measured: Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
Secondary outcomes (6)
Goniometric Measurement of Shoulder Range of Motion
Passive range of motion of the affected shoulder will be measured using a goniometer. Flexion, abduction, internal rotation, and external rotation will be recorded in degrees.
Measured: Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
Shoulder Pain and Disability Index (SPADI)
Shoulder pain and functional limitations will be assessed using the Shoulder Pain and Disability Index (SPADI). The scale consists of 13 items covering pain (5 items) and disability (8 items). Scores range from 0 to 100, with higher scores indicating greater pain and disability.
Measured: Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
Functional Independence Measure (FIM)
Functional independence will be assessed using the Functional Independence Measure (FIM). The scale consists of 18 items evaluating self-care, transfers, locomotion, sphincter control, communication, and social cognition. Each item is scored from 1 (total dependence) to 7 (complete independence). Total scores range from 18 to 126, with higher scores indicating greater functional independence.
Measured: Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
Fugl-Meyer Assessment - Upper Extremity Motor Subscale (FMA-UE)
Upper extremity motor function will be assessed using the Fugl-Meyer Assessment Upper Extremity Motor Subscale (FMA-UE), which evaluates motor function, coordination, and reflex activity in the affected upper extremity. The motor subscale ranges from 0 to 66 points, with higher scores indicating better motor function.
Measured: Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
Modified Ashworth Scale (MAS) for Shoulder Spasticity
Shoulder spasticity will be assessed using the Modified Ashworth Scale (MAS), focusing on shoulder adduction and internal rotation patterns rather than individual muscle isolation. The functional contributions of the subscapularis, pectoralis major, latissimus dorsi, and teres major muscles will be considered. Assessments will be performed with patients in a seated position, with the scapula stabilized. Standardized rapid passive movements will be applied, and resistance to movement will be graded according to MAS criteria (0, 1, 1+, 2, 3, and 4), with higher grades indicating greater muscle tone.
Measured: Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
Shoulder Ultrasonographic Findings
Shoulder ultrasonography will be performed using a 5-12 MHz linear transducer. The acromioclavicular joint, glenohumeral joint, long head of the biceps tendon, rotator cuff tendons (supraspinatus, infraspinatus, and subscapularis), and subacromial-subdeltoid bursa will be evaluated. Acromioclavicular joint abnormalities, glenohumeral subluxation, biceps tendon pathology, bursitis, and rotator cuff tendinopathy will be recorded as present or absent. In patients with partial-thickness rotator cuff tears, the maximum anteroposterior tear diameter will be measured in millimeters. Patients with full-thickness rotator cuff tears will be excluded. Copy
Measured: Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic Shoulder PainStudies 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
- Model description
- This study is designed as a prospective, single-center, randomized, sham-controlled, parallel-group clinical trial. A total of 30 participants with post-stroke hemiplegic shoulder pain will be randomly assigned to either active high-intensity peripheral magnetic stimulation or sham stimulation using a computer-generated randomization sequence. Both groups will receive standard multidisciplinary stroke rehabilitation and a structured therapeutic exercise program.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Atan, MD, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912138
- Sponsor's protocol ID
- E2-26-15492
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers due to participant confidentiality and data privacy considerations.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of High-intensity Peripheral Magnetic Mtimulation in Patients With Post-stroke Hemiplegic Shoulder Pain
- ClinicalTrials.gov ID
- NCT07912138
- Acronym / sponsor ID
- E2-26-15492
- Conditions
- Hemiplegic Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 3 Nov 2026 (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.
This study aims to investigate the effectiveness of high-intensity electromagnetic stimulation using the BTL-6000 Super Inductive System (SIS) in the management of hemiplegic shoulder pain in patients with stroke. Hemiplegic shoulder pain is a common complication following stroke and may negatively affect upper limb function, participation in rehabilitation, and quality of life. The study will evaluate whether treatment with the Super Inductive System can reduce shoulder pain and improve shoulder-related clinical outcomes. The findings are expected to contribute to the evidence regarding non-invasive physical therapy approaches for hemiplegic shoulder pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is designed as a prospective, single-center, randomized, sham-controlled, parallel-group clinical trial. A total of 30 participants with post-stroke hemiplegic shoulder pain will be randomly assigned to either active high-intensity peripheral magnetic stimulation or sham stimulation using a computer-generated randomization sequence. Both groups will receive standard multidisciplinary stroke rehabilitation and a structured therapeutic exercise program.
| Arm | Type | Receives |
|---|---|---|
| Active Peripheral Magnetic Stimulation | Experimental | Device: Active Peripheral Magnetic StimulationParticipants assigned to this group will receive active peripheral magnetic stimulation according to the predefined treatment protocol. The intervention will be administered using the study device under the supervision of trained healthcare professionals. |
| Sham Peripheral Magnetic Stimulation | Sham comparator | Device: Sham Peripheral Magnetic StimulationParticipants assigned to this group will receive sham peripheral magnetic stimulation using a procedure designed to mimic the active intervention without delivering the intended therapeutic magnetic stimulation. The intervention schedule and assessment procedures will be consistent with those of the active stimulation group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults aged 18-75 years.
- History of a first-ever unilateral stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI), occurring more than 3 months before enrollment.
- Hemiplegic shoulder pain with a Visual Analog Scale (VAS) score of at least 4.
- Presence of shoulder pathology identified by clinical examination and ultrasonography.
- Reduced shoulder range of motion.
Key exclusion criteria (13 listed)
- Shoulder pain or restricted shoulder movement before the stroke.
- History of shoulder trauma, infection, malignancy, or surgery.
- Full-thickness rotator cuff tear.
- Shoulder injection within the previous 3 months.
- Previous treatment with high-intensity laser therapy, electromagnetic stimulation, or therapeutic ultrasound.
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 |
|---|---|---|
| Active Peripheral Magnetic StimulationParticipants in the active intervention group will receive active peripheral magnetic stimulation for hemiplegic shoulder pain following stroke. Treatment will be administered using the study device by trained healthcare professionals according to the predefined treatment protocol. | Device | Active Peripheral Magnetic Stimulation |
| Sham Peripheral Magnetic StimulationParticipants in the sham comparator group will receive sham peripheral magnetic stimulation for hemiplegic shoulder pain following stroke. The sham procedure will be designed to mimic the active intervention without delivering therapeutic magnetic stimulation. The treatment schedule and assessment procedures will be consistent with those of the active stimulation group. | Device | Sham Peripheral Magnetic Stimulation |
Primary outcome
Visual Analog Scale (VAS) for Shoulder Pain
Time frame: Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
Shoulder pain will be assessed using the Visual Analog Scale (VAS). Patients will be asked to rate their average shoulder pain experienced at rest and during shoulder movements over the previous 24 hours on a scale from 0 (no pain) to 10 (unbearable pain).
6 secondary outcomes
Goniometric Measurement of Shoulder Range of Motion
Time frame: Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
Shoulder Pain and Disability Index (SPADI)
Time frame: Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
Functional Independence Measure (FIM)
Time frame: Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
Fugl-Meyer Assessment - Upper Extremity Motor Subscale (FMA-UE)
Time frame: Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
Modified Ashworth Scale (MAS) for Shoulder Spasticity
Time frame: Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
Shoulder Ultrasonographic Findings
Time frame: Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers due to participant confidentiality and data privacy considerations.
Related trials for Hemiplegic Shoulder Pain
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain
RecruitingObservational study
Stroke Hemiplegic Shoulder Pain: Ultrasound Findings and VAS (Cross-Sectional)
Hemiplegic Shoulder Pain, Stroke
Recruiting
High-Intensity Laser Therapy in Hemiplegic Shoulder Pain
Hemiplegia and/or Hemiparesis Following Stroke
RecruitingObservational study
Effects of Hemiplegic Shoulder Pain on Upper Extremity Motor Function, Trunk Control, Fear of Falling, Mobility and Indepence in Activities of Daily Living in Patients With Stroke
Stroke
Not yet recruiting
Ultrasound-Guided Pulsed Radiofrequency Versus Phenol Neurolysis for Post-Stroke Hemiplegic Shoulder Pain
Post-Stroke Hemiplegic Shoulder Pain
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.
Questions about this trial
What is this clinical trial studying?
A study testing Active Peripheral Magnetic Stimulation in people with Hemiplegic Shoulder Pain, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital.
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 9 inclusion and 13 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: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tugba Atan, MD (+9 0 312 291 14 14, tubaatan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) for Shoulder Pain (time frame: Baseline and immediately after completion of 10 treatment sessions (approximately 4 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 3 Nov 2026.