Clinical trial NCT06624800: The Efficacy and Safety of Shoulder Chuna on in Patients with Shoulder Pain Caused by Traffic Accidents
Official title: The Efficacy and Safety of Shoulder Chuna on in Patients with Shoulder Pain Caused by Traffic Accidents: a Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Shoulder Pain
Keywords: shoulder chuna therapy
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 98
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Numeric Rating Scale(NRS) of Shoulder pain
timeFrame: Screening, From baseline(Day2) up to Discharge 1 day, 2week after enrollment, 1month after enrollment, 3month after enrollment
Secondary outcomes:
measure: Location of shoulder joint displacement
timeFrame: Screening, From baseline(Day2) up to Discharge 1 day, 2week after enrollment, 1month after enrollment, 3month after enrollment
measure: Shoulder Pain intensity scale: Visual Analogue Scale (VAS)
timeFrame: From baseline(Day2) up to Discharge 1 day
measure: Physical examination (Shoulder active range of motion)
timeFrame: From baseline(Day2) up to Discharge 1 day
measure: Shoulder Pain and Disability Index(SPADI)
timeFrame: From baseline(Day2) up to Discharge 1 day, 2week after enrollment, 1month after enrollment, 3month after enrollment
measure: EuroQol 5-Dimension (EQ-5D)
timeFrame: From baseline(Day2) up to Discharge 1 day, 2week after enrollment, 1month after enrollment, 3month after enrollment
measure: Patient Global Impression of Change (PGIC)
timeFrame: Discharge 1 day, 2week after enrollment, 1month after enrollment, 3month after enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
state: Gangnam-Gu
Study officials:
affiliation: Jaseng Medical Foundation
name: In-Hyuk Ha, phD
role: STUDY_DIRECTOR
References: