A Pragmatic Randomized Controlled Trial: The Efficacy and Safety of Shoulder MSAT on in Patients With Shoulder Pain

NCT ID: NCT07187336

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-30
• Study Completion Date: 2026-12-31

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.

Conditions

Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Shoulder MSAT Group

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.

Group Type: EXPERIMENTAL

Integrative Korean Medicine Only Group

Intervention Type: 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.

Integrative Korean Medicine Only Group

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.

Group Type: EXPERIMENTAL

Shoulder MSAT Group

Intervention Type: 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

Intervention Type: 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.

Interventions

Shoulder 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.

Intervention Type: PROCEDURE

Integrative 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jaseng Medical Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

In-Hyuk Ha, phD

Role: PRINCIPAL_INVESTIGATOR

Jaseng Medical Foundation

Central Contacts

In-Hyuk Ha, phD

Role: CONTACT

hanitata@jaseng.co.kr

02-2222-2740

Other Identifiers

JS-CT-2025-09

Identifier Type: -

Identifier Source: org_study_id