A Pragmatic Randomized Controlled Trial: The Efficacy and Safety of Shoulder MSAT on in Patients With Shoulder Pain
- Conditions
- Shoulder Pain
- Registration Number
- NCT07187336
- Lead Sponsor
- Jaseng Medical Foundation
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 98
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Numeric Rating Scale, NRS Baseline (Day 2, before treatment) to Day 5 (end of hospitalization). Patient-reported shoulder pain intensity on a 0-10 scale (0 = no pain, 10 = worst pain).
- Secondary Outcome Measures
Name Time Method Shoulder Range of Motion (ROM) Baseline, Day 5, 2 weeks, and 1 month after enrollment. Active and passive ROM in six directions (flexion, extension, abduction, adduction, internal rotation, external rotation), measured with a goniometer.
Shoulder Pain and Disability Index (SPADI) Baseline, Day 5, 2 weeks, and 1 month after enrollment. 13-item questionnaire assessing pain (5 items) and disability (8 items), each scored 0-10; higher scores indicate greater disability.
Quality of Life (EQ-5D-5L) Baseline, Day 5, 2 weeks, and 1 month after enrollment. Standardized instrument assessing mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Patient Global Impression of Change (PGIC) Day 5, 2 weeks, and 1 month after enrollment. 7-point scale of overall improvement reported by the patient.
Adverse Events During hospitalization, and at 2 weeks and 1 month follow-up. Any expected or unexpected adverse reactions (e.g., local pain, bruising, systemic reactions) assessed by patient report and investigator observation.