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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), or
Integrative Korean medicine only group (acupuncture, herbal medicine, pharmacopuncture, Chuna therapy).
MSAT involves inserting needles into the shoulder area and gently moving the joint to improve pain relief and mobility. All treatments used in this study are standard care in Korean medicine.
The main outcomes are pain reduction, shoulder movement, daily function, quality of life, and patient satisfaction. Safety will also be monitored by recording any side effects such as temporary soreness, bruising, or discomfort.
Treatment will be provided during hospitalization (up to 5 days), and patients will be followed up by phone at 2 weeks and 1 month after enrollment.
The results of this trial will help determine whether adding MSAT to standard integrative Korean medicine treatment provides greater benefit for patients with acute shoulder pain after traffic accidents.
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, and herbal medicine are commonly used, there is limited high-quality evidence regarding the additional benefits of MSAT for shoulder conditions.
MSAT is a therapeutic technique in which acupuncture needles are inserted into affected areas while the practitioner guides or assists the patient's shoulder movements. This combined approach aims to enhance the analgesic and functional effects of acupuncture.
In this trial, 98 inpatients with acute shoulder pain following a traffic accident will be randomized equally into two groups. One group will receive integrative Korean medicine plus MSAT, and the other will receive integrative Korean medicine alone. MSAT will be performed once daily for three sessions during hospitalization (days 2-4), while both groups will continue standard integrative treatments.
The study will assess clinical effectiveness through changes in shoulder pain intensity, range of motion, functional status, quality of life, and patient global impression of change. Safety will be evaluated by monitoring adverse events during treatment and follow-up.
By comparing outcomes between the two groups, this study aims to provide evidence on whether MSAT offers additional benefit beyond integrative Korean medicine for patients with acute shoulder pain after traffic accidents. The findings are expected to contribute to establishing clinical guidance for safe and effective use of MSAT in real-world practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shoulder MSAT Group | Experimental | 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 integrative treatments: Acupuncture, pharmacopuncture, Chuna manual therapy, and herbal medicine, all provided as standard care. |
|
| Integrative Korean Medicine Only Group | Experimental | 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 hospitalization. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shoulder MSAT Group | Procedure | 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 consecutive days (hospital days 2-4), in addition to standard integrative Korean medicine treatment (acupuncture, pharmacopuncture, Chuna manual therapy, and herbal medicine). Each MSAT session lasts about 10-20 minutes. This distinguishes the intervention from the comparator arm, which receives integrative Korean medicine treatment only, without MSAT. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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
Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| In-Hyuk Ha, phD | Contact | 02-2222-2740 | hanitata@jaseng.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| In-Hyuk Ha, phD | Jaseng Medical Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haeundae Jaseng Hospital of Korean Medicine | Recruiting | Busan | Haeundae | 48102 | South Korea |
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A Pragmatic randomized controlled trial
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| Integrative Korean Medicine Only Group | Procedure | 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 effects of MSAT, since both groups receive the same integrative Korean medicine but only the experimental arm includes Shoulder MSAT. |
|
| 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. |
| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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