Clinical trial NCT06931951: The Effectiveness and Safety of Pharmacopuncture on Inpatients With Acute Knee Pain Caused by Traffic Accidents
Official title: The Effectiveness and Safety of Pharmacopuncture on Inpatients With Acute Knee Pain Caused by Traffic Accidents : A Pragmatic Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pharmacologic Action
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 40
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: The purpose of this study is to reveal the effectiveness and safety of knee herbal acupuncture for patients with acute knee joint pain caused by a traffic accident. It is a practical clinical study to confirm the comparative effectiveness by comparing the strategy of treating knee herbal acupuncture in parallel with the strategy of treating it with integrated oriental medicine treatment, which is an existing treatment method.


Eligibility criteria: Inclusion Criteria:

* When the NRS (Numeric Rating Scale) of knee pain caused by a traffic accident is 5 or higher.
* Patients hospitalized for traffic accident treatment.
* Patients with acute pain within 14 days of experiencing knee pain due to a traffic accident.
* Patients aged between 19 and 70 years old.
* participants who agree to participate in clinical research and provide written test subject consent.

Exclusion Criteria:

* For patients diagnosed with a specific serious disease that may cause knee pain (acute fracture, dislocation, complete rupture of ligaments, etc.)
* If the cause of the pain is caused by a disease other than the knee (tumor, fibromyalgia, rheumatoid arthritis, gout, lumbar disc herniation, etc.)
* Cases where surgical intervention is required due to suspected acute fracture, dislocation, or ligament and cartilage damage
* If there is another acute disease (stroke, myocardial infarction, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.) that may interfere with the treatment effect or interpretation of results
* Patients currently taking steroids, immunosuppressants, mental illness drugs, or other drugs that may affect their findings
* Inadequate or unsafe medication: hemorrhagic disease, anticoagulant therapy, severe diabetic patients with risk of infection
* Patients who have taken drugs that may affect pain, such as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), or have received herbal acupuncture or physical therapy within the past week
* In the case of pregnant women and in the case of planning to become pregnant or nursing
* Patients within 3 months after knee surgery or if knee replacement surgery was performed
* If it has been less than 1 month since participants finished participating in another clinical study, or if participants are planning to participate in another clinical study during the study participation and follow-up period within 6 months from the date of selection
* If it is difficult to fill out the consent form for research participation
* In cases where it is difficult for other researchers to participate in clinical research

Primary outcomes:
measure: Knee pain numeric rating scale (NRS)
timeFrame: through admission completion, an average of 1week, 2 weeks and 4 weeks after admission date
Secondary outcomes:
measure: Range of motion (ROM)
timeFrame: Enrollment date, Discharge date(On average, 1 week after admission)
measure: Korean Western Ontario & McMaster, K-WOMAC
timeFrame: Enrollment date, Discharge date(On average, 1 week after admission), 2 and 4 weeks after admission date
measure: EuroQol-5 Dimension (EQ-5D-5L)
timeFrame: Enrollment date, Discharge date(On average, 1 week after admission), 2 and 4 weeks after admission date
measure: Patient Global Impression of Change (PGIC)
timeFrame: Discharge date(On average, 1 week after admission), 2 and 4 weeks after admission date
Other outcomes:
Locations:
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