The Effectiveness and Safety of Pharmacopuncture on Inpatients With Acute Knee Pain Caused by Traffic Accidents

NCT06931951 | Recruiting DMC

• 1 other identifier: JS-CT-2025-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacologic Action

Outcome Measures

Primary Outcomes (1)

• Knee pain numeric rating scale (NRS)

  The intensity of knee pain will be assessed using the NRS. In the NRS, participants choose a number from 0 to 10 that best describes participant's comfort (0 being no pain and 10 being the most comfortable they can imagine).

  through admission completion, an average of 1week, 2 weeks and 4 weeks after admission date

Secondary Outcomes (4)

• Range of motion (ROM)

  Enrollment date, Discharge date(On average, 1 week after admission)

• Korean Western Ontario & McMaster, K-WOMAC

  Enrollment date, Discharge date(On average, 1 week after admission), 2 and 4 weeks after admission date

• EuroQol-5 Dimension (EQ-5D-5L)

  Enrollment date, Discharge date(On average, 1 week after admission), 2 and 4 weeks after admission date

• Patient Global Impression of Change (PGIC)

  Discharge date(On average, 1 week after admission), 2 and 4 weeks after admission date

Study Arms (2)

Knee Pharmacoacupuncture group

EXPERIMENTAL

20 patients in the Knee Pharmacoacupuncture group

Procedure: Knee Pharmacoacupuncture

Oriental medicine integrated treatment group

ACTIVE COMPARATOR

20 patients in the Oriental medicine integrated treatment group

Procedure: Oriental medicine integrated treatment

Interventions

Knee Pharmacoacupuncture PROCEDURE

Physician choose the adequate type and dose of pharmacoacupuncture and needle type

Also known as: Drug: Herbal extract-based pharmacopuncture

Knee Pharmacoacupuncture group

Oriental medicine integrated treatment PROCEDURE

Physician choose the integrated oriental medicine treatment other than herbal acupuncture.

Also known as: Device: Acupuncture needles, cupping devices, and moxibustion devices, etc.

Oriental medicine integrated treatment group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, South Korea

RECRUITING

Central Study Contacts

Sunah Kim KMD

CONTACT

82-42-1577-0007; tnsdk2648@jaseng.org

Eunyul Han KMD

CONTACT

82-010-8343-0929; yul123@jaseng.org

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

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: April 17, 2025
• Study Start: May 22, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)