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

NCT07187336 | Recruiting DMC

• 1 other identifier: JS-CT-2025-09
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain

Keywords

motion style acupuncture treatment

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Day 2, before treatment) to Day 5 (end of hospitalization).

Secondary Outcomes (5)

• Shoulder Range of Motion

  Baseline, Day 5, 2 weeks, and 1 month after enrollment.

• Shoulder Pain and Disability Index

  Baseline, Day 5, 2 weeks, and 1 month after enrollment.

• EuroQol 5-Dimension 5-Level Questionnaire

  Baseline, Day 5, 2 weeks, and 1 month after enrollment.

• Patient Global Impression of Change

  Day 5, 2 weeks, and 1 month after enrollment.

• Adverse Events

  During hospitalization, and at 2 weeks and 1 month follow-up.

Study Arms (2)

Shoulder MSAT Group

EXPERIMENTAL

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.

Procedure: Shoulder MSAT Group

Integrative Korean Medicine Only Group

EXPERIMENTAL

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.

Procedure: Integrative Korean Medicine Only Group

Interventions

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.

Shoulder MSAT Group

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.

Integrative Korean Medicine Only Group

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Haeundae Jaseng Hospital of Korean Medicine

Busan, Haeundae, 48102, South Korea

RECRUITING

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• In-Hyuk Ha, phD

  Jaseng Medical Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

In-Hyuk Ha, phD

CONTACT

02-2222-2740; hanitata@jaseng.co.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Pragmatic randomized controlled trial

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 23, 2025
• Study Start: November 2, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)