Shoulder Pain
Conditions
Keywords
motion style acupuncture treatment
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREShoulder 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 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.
PROCEDUREIntegrative 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 effects of MSAT, since both groups receive the same integrative Korean medicine but only the experimental arm includes Shoulder MSAT.
Sponsors
Jaseng Medical Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
A Pragmatic randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale for Shoulder Pain | Baseline (Day 2, before treatment) to Day 5 (end of hospitalization). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder Range of Motion | Baseline, Day 5, 2 weeks, and 1 month after enrollment. | 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. |
| Shoulder Pain and Disability Index | Baseline, Day 5, 2 weeks, and 1 month after enrollment. | 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. |
| EuroQol 5-Dimension 5-Level Questionnaire | Baseline, Day 5, 2 weeks, and 1 month after enrollment. | 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. |
| Patient Global Impression of Change | Day 5, 2 weeks, and 1 month after enrollment. | 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. |
| Adverse Events | During hospitalization, and at 2 weeks and 1 month follow-up. | 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. |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORIn-Hyuk Ha, phD
Jaseng Medical Foundation
Outcome results
None listed