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

January 13, 2026 updated by: Jaseng Medical Foundation

The Effectiveness and Safety of Pharmacopuncture on Inpatients With Acute Knee Pain Caused by Traffic Accidents : A Pragmatic Randomized Controlled Pilot Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • South Korea
      • Daejeon, South Korea
        • Recruiting
        • Daejeon Jaseng Hospital of Korean Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Knee Pharmacoacupuncture group
20 patients in the Knee Pharmacoacupuncture group
Procedure: Knee Pharmacoacupuncture
Physician choose the adequate type and dose of pharmacoacupuncture and needle type
Other Names:
  • Drug: Herbal extract-based pharmacopuncture
Active Comparator: Oriental medicine integrated treatment group
20 patients in the Oriental medicine integrated treatment group
Procedure: Oriental medicine integrated treatment
Physician choose the integrated oriental medicine treatment other than herbal acupuncture.
Other Names:
  • Device: Acupuncture needles, cupping devices, and moxibustion devices, etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee pain numeric rating scale (NRS)
Time Frame: through admission completion, an average of 1week, 2 weeks and 4 weeks after admission date
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion (ROM)
Time Frame: Enrollment date, Discharge date(On average, 1 week after admission)
Passive ROM will be measured before and after treatment to evaluate changes before and after treatment. Passive ROM is evaluated by measuring the angle between the subject's lower extremity and an imaginary line drawn vertically from the ground at the maximum range of motion of the subject's knee joint in flexion, extension, left flexion, and right flexion. If measurement is not possible due to pain, it will be recorded as UC.
Enrollment date, Discharge date(On average, 1 week after admission)
Korean Western Ontario & McMaster, K-WOMAC
Time Frame: Enrollment date, Discharge date(On average, 1 week after admission), 2 and 4 weeks after admission date
K-WOMAC is a 24-item questionnaire developed to evaluate the degree of disability related to knee pain. Each question is divided into 5 levels and consists of 5 questions in the pain evaluation section, 2 questions in the stiffness evaluation section, and 17 questions in the functional disability evaluation section. The higher the score, the more severe the disability.
Enrollment date, Discharge date(On average, 1 week after admission), 2 and 4 weeks after admission date
EuroQol-5 Dimension (EQ-5D-5L)
Time Frame: Enrollment date, Discharge date(On average, 1 week after admission), 2 and 4 weeks after admission date
EQ-5D-5L is a method of evaluating health status from various aspects and then indirectly calculating the quality weight of a specific health status using pre-assigned preference scores for each functional level. It is the most widely used among several indirect measurement methods. there is. The EQ-5D-5L consists of 5 questions. Each question includes mobility, self-care, usual activities, pain/discomfort, and anxiety/depression ( Ask about the level of anxiety/depression, etc. Weights are assigned according to the level of each item, and the preference score calculation equation is presented based on these weights and constants.
Enrollment date, Discharge date(On average, 1 week after admission), 2 and 4 weeks after admission date
Patient Global Impression of Change (PGIC)
Time Frame: Discharge date(On average, 1 week after admission), 2 and 4 weeks after admission date
This is a method that allows participants to subjectively evaluate the degree of improvement on a 7-level scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Discharge date(On average, 1 week after admission), 2 and 4 weeks after admission date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaseng Medical Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 12, 2025

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • JS-CT-2025-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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