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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
98
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.
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.
Haeundae Jaseng Hospital of Korean Medicine
Busan, Haeundae, South Korea
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.
Time frame: Baseline (Day 2, before treatment) to Day 5 (end of hospitalization).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During hospitalization, and at 2 weeks and 1 month follow-up.
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