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NCT Number: NCT07187336

The Efficacy and Safety of Shoulder Motion Style Acupuncture Treatment (MSAT) on in Patients With Shoulder Pain Caused by Traffic Accidents

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.

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Key information

Conditions

Shoulder Pain Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haeundae Jaseng Hospital of Korean Medicine

Busan, Haeundae, 48102, South Korea

Location status: Recruiting

Location contact

Min Ryeong Park, KMD

CONTACT

[email protected]

+82-10-2256-4650

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Numeric Rating Scale for Shoulder Pain

    Time frame: 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 outcomes

  1. Shoulder Range of Motion

    Time frame: 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.

  2. Shoulder Pain and Disability Index

    Time frame: 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.

  3. EuroQol 5-Dimension 5-Level Questionnaire

    Time frame: 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.

  4. Patient Global Impression of Change

    Time frame: 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.

  5. Adverse Events

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

In-Hyuk Ha, phD

CONTACT

[email protected]

02-2222-2740

Sponsors and collaborators

Lead sponsor

Jaseng Medical Foundation

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2025
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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