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Recruiting NCT06931951

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

No phase Interventional Pharmacologic Action

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Knee Pharmacoacupuncture, Oriental medicine integrated treatment.
Who it may be relevant to
Registry conditions: Pharmacologic Action. Basic parameters: 19 years — 69 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Procedure Knee Pharmacoacupuncture
    Physician choose the adequate type and dose of pharmacoacupuncture and needle type
  • Procedure Oriental medicine integrated treatment
    Physician choose the integrated oriental medicine treatment other than herbal acupuncture.

Primary outcome measures

  • Knee pain numeric rating scale (NRS) [Time frame: through admission completion, an average of 1week, 2 weeks and 4 weeks after admission date]
Secondary outcome measures (4)
  • Range of motion (ROM) [Time frame: 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]
  • 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]
  • Patient Global Impression of Change (PGIC) [Time frame: Discharge date(On average, 1 week after admission), 2 and 4 weeks after admission date]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Daejeon Jaseng Hospital of Korean Medicine — Daejeon

Identifiers

NCT: NCT06931951 · JS-CT-2025-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗