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L'essai clinique NCT07187336 pour Douleur à l'épaule est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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The Efficacy and Safety of Shoulder Motion Style Acupuncture Treatment (MSAT) on in Patients With Shoulder Pain Caused by Traffic Accidents 98
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L'essai clinique NCT07187336 est une étude interventionnel pour Douleur à l'épaule. Son statut actuel est : en recrutement. L'étude a débuté le 2 novembre 2025 et vise à recruter 98 participants. Dirigée par Jaseng Medical Foundation, l'étude devrait être terminée d'ici le 30 septembre 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 9 mars 2026.
Résumé succinct
This study will test the effectiveness and safety of Motion Style Acupuncture Treatment (MSAT) for shoulder pain caused by traffic accidents. About 98 hospitalized patients with acute shoulder pain after a traffic accident will take part.
Participants will be randomly assigned to one of two groups:
MSAT + integrative Korean medicine group (acupuncture, herbal medicine, pharmacopuncture, Chuna therapy, plus MSAT), o...
Afficher plusDescription détaillée
This pragmatic randomized controlled trial is designed to evaluate the efficacy and safety of Motion Style Acupuncture Treatment (MSAT) for acute shoulder pain resulting from traffic accidents. Shoulder injuries after motor vehicle accidents often cause pain, restricted range of motion, and functional limitations. While integrative Korean medicine treatments such as acupuncture, pharmacopuncture, Chuna manual therapy...Afficher plus
Titre officiel
The Efficacy and Safety of Shoulder Motion Style Acupuncture Treatment (MSAT) on in Patients With Shoulder Pain Caused by Traffic Accidents: A Pragmatic Randomized Controlled Trial
Pathologies
Douleur à l'épauleAutres identifiants de l'étude
- JS-CT-2025-09
Numéro NCT
Date de début (réel)
2025-11-02
Dernière mise à jour publiée
2026-03-09
Date de fin (estimée)
2026-09-30
Inscription (estimée)
98
Type d'étude
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
motion style acupuncture treatment
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Simple aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalShoulder MSAT Group Participants receive integrative Korean medicine treatment plus Shoulder Motion Style Acupuncture Treatment (MSAT).
MSAT: Acupuncture needles are inserted into the affected shoulder, and the practitioner guides or assists joint movements while the needles are retained. This aims to enhance pain relief and improve mobility.
Treatment schedule: Once daily, 3 sessions during hospitalization (days 2-4).
Additional int...Afficher plus | Shoulder MSAT Group Shoulder Motion Style Acupuncture Treatment (MSAT) involves inserting acupuncture needles into specific points around the shoulder joint, then guiding or assisting the patient's shoulder movements while the needles remain in place. This combined technique is intended to maximize acupuncture effects by stimulating both the needles and the joint motion.
In this study, MSAT will be performed once daily for three consec...Afficher plus |
ExpérimentalIntegrative Korean Medicine Only Group Participants receive integrative Korean medicine treatment only, without MSAT.
Acupuncture: 6-10 points selected by the practitioner; 15-20 minutes per session.
Pharmacopuncture: Injection of herbal extracts into acupuncture points.
Chuna manual therapy: Manual therapy for 10-15 minutes daily.
Herbal medicine: Decoction extracts packaged in pouches, taken twice daily after meals.
Treatment schedule: Daily during...Afficher plus | Integrative Korean Medicine Only Group Participants in this group receive only standard integrative Korean medicine treatments, without MSAT. Treatments include acupuncture (6-10 points, 15-20 minutes per session), pharmacopuncture (injection of herbal extracts at acupuncture points), Chuna manual therapy (10-15 minutes daily), and herbal medicine (oral decoction extracts taken twice daily).
This arm serves as the comparator to distinguish the additional...Afficher plus |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Numeric Rating Scale for Shoulder Pain | Patient-reported shoulder pain intensity measured using the Numeric Rating Scale, ranging from a minimum score of 0 (no pain) to a maximum score of 10 (worst imaginable pain). Higher scores indicate more severe pain and a worse outcome. | Baseline (Day 2, before treatment) to Day 5 (end of hospitalization). |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Shoulder Range of Motion | Active and passive shoulder range of motion measured in degrees using a goniometer in six directions: flexion (minimum 0°, maximum 180°), extension (0°-60°), abduction (0°-180°), adduction (0°-45°), internal rotation (0°-90°), and external rotation (0°-90°). Higher values indicate greater shoulder mobility and a better outcome. | Baseline, Day 5, 2 weeks, and 1 month after enrollment. |
Shoulder Pain and Disability Index | The Shoulder Pain and Disability Index is a 13-item patient-reported questionnaire assessing shoulder pain (5 items) and disability (8 items). Each item is scored from a minimum of 0 to a maximum of 10. Subscale and total scores are calculated according to the instrument scoring guidelines, with higher scores indicating greater shoulder pain and disability and therefore a worse outcome. | Baseline, Day 5, 2 weeks, and 1 month after enrollment. |
EuroQol 5-Dimension 5-Level Questionnaire | The EuroQol 5-Dimension 5-Level questionnaire is a standardized, patient-reported measure of health-related quality of life assessing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 5-level scale. Responses are converted to an index value according to the country-specific value set, with higher index values indicating better health-related quality of life and a better outcome. | Baseline, Day 5, 2 weeks, and 1 month after enrollment. |
Patient Global Impression of Change | The Patient Global Impression of Change is a patient-reported measure of overall change in condition since the start of the study, assessed on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Lower scores indicate greater improvement and a better outcome. | Day 5, 2 weeks, and 1 month after enrollment. |
Adverse Events | Any expected or unexpected adverse events assessed throughout the study, including but not limited to local pain, bruising, and systemic reactions, as reported by the patient and observed by the investigator. Adverse events are recorded by type, frequency, severity, and relationship to the intervention. Higher numbers of adverse events indicate worse safety outcomes. | During hospitalization, and at 2 weeks and 1 month follow-up. |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
19 Years
Sexes éligibles
Tous
Adults aged 19 to 70 years
Hospitalized with shoulder pain within 5 days after a traffic accident
Shoulder pain intensity ≥ 5 on the Numeric Rating Scale (NRS) with observed limitation of movement
Able and willing to provide written informed consent
Serious conditions causing shoulder pain (e.g., malignant tumor, infection)
Progressive or severe neurological deficits
Recent shoulder surgery or procedure within 3 weeks
Shoulder pain mainly due to non-shoulder disorders (e.g., fibromyalgia, rheumatoid arthritis, gout)
Contraindications to MSAT (e.g., fracture, dislocation, ligament rupture or instability, severe inflammation)
Chronic diseases interfering with assessment (e.g., cardiovascular disease, renal disease, diabetic neuropathy, dementia, epilepsy)
Current use of steroids, immunosuppressants, psychiatric drugs, or other medications that may affect results
Contraindications to acupuncture (e.g., bleeding disorders, anticoagulant use, severe diabetes, severe cardiovascular disease)
Pregnant or planning pregnancy
Severe psychiatric illness
Participation in another interventional clinical trial
Unable to provide informed consent
Any other condition deemed inappropriate by the investigator
Jaseng Medical FoundationContact central de l'étude
Contact: In-Hyuk Ha, phD, 02-2222-2740, [email protected]
1 Centres de l'étude dans 1 pays
Haeundae
Haeundae Jaseng Hospital of Korean Medicine, Busan, Haeundae, 48102, South Korea
Min Ryeong Park, KMD, Contact, +82-10-2256-4650, [email protected]
En recrutement