The Efficacy and Safety of Shoulder Chuna on in Patients With Shoulder Pain Caused by Traffic Accidents

NCT06624800 | Terminated DMC

• 2 other identifiers: JS-CT-2024-08Jaseng Medical Foundation
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a double blind, randomized controlled trail. condition/disease: Patient with acute shoulder pain and restricted movement due to a traffic accident. treatment/intervention: Chuna therapy for the shoulder, including integrated Korean medicine treatment

Conditions

Acute Shoulder Pain

Keywords

shoulder chuna therapy

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale(NRS) of Shoulder pain

  NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10. The participant is asked to report their shoulder pain and discomfort using NRS, where 0 indicates \'no pain or discomfort\' and 10 indicates \'the most severe pain and discomfort imaginable\'.

  Screening, From baseline(Day2) up to Discharge 1 day, 2week after enrollment, 1month after enrollment, 3month after enrollment

Secondary Outcomes (6)

• Location of shoulder joint displacement

  Screening, From baseline(Day2) up to Discharge 1 day, 2week after enrollment, 1month after enrollment, 3month after enrollment

• Shoulder Pain intensity scale: Visual Analogue Scale (VAS)

  From baseline(Day2) up to Discharge 1 day

• Physical examination (Shoulder active range of motion)

  From baseline(Day2) up to Discharge 1 day

• Shoulder Pain and Disability Index(SPADI)

  From baseline(Day2) up to Discharge 1 day, 2week after enrollment, 1month after enrollment, 3month after enrollment

• EuroQol 5-Dimension (EQ-5D)

  From baseline(Day2) up to Discharge 1 day, 2week after enrollment, 1month after enrollment, 3month after enrollment

Study Arms (2)

Shoulder chuna treatment

EXPERIMENTAL

During the hospitalization period, Chuna therapy for the shoulder joint will be performed once a day for a total of 10 to 15 minutes, including before, during, and after the treatment. The practitioner will assess the condition and select one of three techniques-posterior displacement, anterior displacement, or lateral displacement-to apply Chuna therapy

Procedure: Korean medical treatment

Korean medical treatment

ACTIVE COMPARATOR

The control group were received Korean medical treatment everyday after hospitalization: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.

Procedure: Shoulder chuna treatment(posterior displacement, anterior displacement, or lateral displacement); Procedure: Korean medical treatment

Interventions

Shoulder chuna treatment(posterior displacement, anterior displacement, or lateral displacement) PROCEDURE

The Shoulder Chuna therapy for the shoulder joint will be performed on the affected shoulder from the second day of hospitalization until the day before discharge.

Korean medical treatment

Korean medical treatment PROCEDURE

acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine

Korean medical treatment; Shoulder chuna treatment

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 19-69 years on the date they sign the consent form.
• Patients with shoulder pain and restricted movement occurring within 5 days after a traffic accident.
• Patients who are hospitalized due to traffic accident.
• Patients with NRS of shoulder pain ≥ 5 with restricted movement due to a traffic accident.
• Patients who provide consent to participate in the trial and return the informed consent form.

You may not qualify if:

• Patients with a specific serious disease that may cause shoulder pain: malignancy, spondylitis, inflammatory spondylitis, etc.
• Patients with progressive neurological deficits or with severe neurological symptoms.
• Patients with medical history of cervical surgery or shoulder surgery within the last three weeks.
• Patients with a specific serious disease that may interfere with the interpretation of the therapeutic effects or results: malignancy, spondylitis, inflammatory spondylitis, etc.
• Chuna therapy is deemed inappropriate or unsafe due to conditions like fractures, dislocations, ligament tears, or unstable healing fractures; skeletal demineralization and ligament laxity with subluxation or dislocation; or inflammation
• Presence of other chronic diseases that could interfere with treatment outcomes or interpretation, such as cardiovascular disease, kidney disease, diabetic neuropathy, dementia, or epilepsy
• Currently taking steroids, immunosuppressants, psychiatric medications, or other drugs that may affect study results
• Acupuncture is deemed inappropriate or unsafe, such as in patients with bleeding disorders, those on anticoagulant therapy, those with severe diabetes prone to infection, or those with severe cardiovascular disease
• Patients who are pregnant or planning to become pregnant.
• Patients who are presence of severe mental illness
• Patients who are participated in clinical trials other than observational studies without therapeutic intervention.
• Patients who are difficult to complete the research participation agreement.
• Other patients whose participation in the trial is judged by a researcher to be problematic.

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, 135-896, South Korea

Location

Study Officials

• In-Hyuk Ha, phD

  Jaseng Medical Foundation

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 3, 2024
• Study Start: November 4, 2024
• Primary Completion: July 5, 2025
• Study Completion: November 10, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)