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

NCT ID: NCT06624800

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-04

Study Completion Date

2025-12-31

Brief Summary

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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

Detailed Description

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The investigators intend to conduct a randomized controlled trial to evaluate the effectiveness of Chuna therapy for shoulder pain and restricted movement caused by a traffic accident. The study will involve administering shoulder Chuna therapy from the second day of hospitalization until discharge, with the aim of assessing its effects on shoulder pain relief and recovery of range of motion. Although the effectiveness of Korean medicine for treating trauma from traffic accidents has been well studied, the research has largely focused on spinal conditions, such as those affecting the cervical and lumbar spine. Likewise, most studies on Chuna therapy have centered around spinal disorders. Through this study, the investigators aim to explore the therapeutic effects of shoulder Chuna therapy, an area that has not been extensively researched.

1. The effectiveness of shoulder Chuna therapy will be evaluated by observing and comparing changes in pain, range of motion limitation, functional disability, quality of life, and patient satisfaction between the shoulder Chuna group (treatment group) and the Korean integrative medicine group (control group).
2. Investigators will assess the treatment effects of shoulder Chuna therapy on shoulder pain and restricted movement by observing improvements in initial NRS, VAS scores, SPADI, and ROM in the shoulder Chuna group (treatment group) compared to the Korean integrative medicine group (control group).
3. The total number of treatment sessions and the degree of improvement will be observed and compared between the shoulder Chuna group (treatment group) and the Korean integrative medicine group (control group) to evaluate the effectiveness of the treatment frequency.
4. The safety of the therapy will be assessed by investigating adverse reactions in both the shoulder Chuna group (treatment group) and the Korean integrative medicine group (control group).

Conditions

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Acute Shoulder Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Shoulder chuna treatment

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

Group Type EXPERIMENTAL

Korean medical treatment

Intervention Type PROCEDURE

acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine

Korean medical treatment

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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

Intervention Type PROCEDURE

acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine

Interventions

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

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.

Intervention Type PROCEDURE

Korean medical treatment

acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jaseng Medical Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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In-Hyuk Ha, phD

Role: STUDY_DIRECTOR

Jaseng Medical Foundation

Locations

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Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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In-Hyuk In-Hyuk Ha, phD

Role: CONTACT

02-2222-2740 ext. 02-2222-2740

Facility Contacts

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Ha IH In-Hyuk Ha, phD

Role: primary

3218-2249 ext. Ext. 82

Other Identifiers

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Jaseng Medical Foundation

Identifier Type: OTHER

Identifier Source: secondary_id

JS-CT-2024-08

Identifier Type: -

Identifier Source: org_study_id