Effectiveness of High-intensity Peripheral Magnetic Stimulation on Hemiplegic Shoulder Pain After Stroke
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Tugba Atan, MD
- Numéro de téléphone: +9 0 312 291 14 14
- E-mail: tubaatan@gmail.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
- Mini-Mental State Examination (MMSE) score of at least 18.
- Ability to provide written informed consent.
Exclusion Criteria:
- 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.
- 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
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. |
|
Comparateur factice: 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. |
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Visual Analog Scale (VAS) for Shoulder Pain
Délai: 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). |
Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Goniometric Measurement of Shoulder Range of Motion
Délai: Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
|
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. |
Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
|
|
Shoulder Pain and Disability Index (SPADI)
Délai: Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
|
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. |
Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
|
|
Functional Independence Measure (FIM)
Délai: Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
|
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. |
Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
|
|
Fugl-Meyer Assessment - Upper Extremity Motor Subscale (FMA-UE)
Délai: Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
|
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. |
Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
|
|
Modified Ashworth Scale (MAS) for Shoulder Spasticity
Délai: Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
|
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. |
Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
|
|
Shoulder Ultrasonographic Findings
Délai: Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
|
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 |
Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- E2-26-15492
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Individual participant data will not be shared with other researchers due to participant confidentiality and data privacy considerations.
Informations sur les médicaments et les dispositifs, documents d'étude
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