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Not yet recruitingNCT07912138Updated Nov 3, 2026

Effectiveness of High-intensity Peripheral Magnetic Stimulation on Hemiplegic Shoulder Pain After Stroke

An interventional study of Active Peripheral Magnetic Stimulation and Sham Peripheral Magnetic Stimulation in Hemiplegic Shoulder Pain, sponsored by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital · Not applicable, Interventional, and Treatment

Updated Nov 3, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Hemiplegic Shoulder Pain

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03

In context

Shoulder Pain

735 studies on the registry are indexed under Shoulder Pain; 167 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 587 interventional studies indexed under Shoulder Pain.

Browse Shoulder Pain studies →

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital is the lead sponsor of 85 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.
  • Clinically stable condition.
  • (MMSE) score of at least 18.
  • Ability to provide written .

Exclusion criteria

Exclusion Criteria:

  • Shoulder pain or restricted shoulder movement before the stroke.
  • History of shoulder trauma, infection, , 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.
  • Modified Ashworth Scale (MAS) score of 3 or higher.
  • Cervical radiculopathy or another neurological disorder.
  • Inflammatory rheumatic disease.
  • Uncontrolled diabetes mellitus ( 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Active Peripheral Magnetic Stimulation

    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.

    Device: Active Peripheral Magnetic Stimulation

  • Sham comparator
    Sham Peripheral Magnetic Stimulation

    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.

    Device: Sham Peripheral Magnetic Stimulation

Interventions

  • DeviceActive Peripheral Magnetic Stimulation

    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.

  • DeviceSham Peripheral Magnetic Stimulation

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)

Secondary outcomes

  1. 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.

    Time frame: Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)

  2. 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.

    Time frame: Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)

  3. 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.

    Time frame: Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)

  4. 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.

    Time frame: Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)

  5. 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.

    Time frame: Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)

  6. 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

    Time frame: Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared with other researchers due to participant confidentiality and data privacy considerations.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07912138
Lead sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Responsible party
Tuğba Atan, MD (Associate Professor of Physical Medicine and Rehabilitation, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital) — Principal investigator
First posted
Nov 3, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Aug 1, 2027 (estimated)
Completion
Aug 1, 2027 (estimated)
Last update
Nov 3, 2026

Study contacts

Tugba Atan, MD
Contact
tubaatan@gmail.com
+9 0 312 291 14 14

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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