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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-69
SponsorJaseng Medical Foundation

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Knee Pharmacoacupuncture

    Procedure/Surgery

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

  • Oriental medicine integrated treatment

    Procedure/Surgery

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Knee Pharmacoacupuncture groupExperimental treatment 1 intervention
Group B: Oriental medicine integrated treatment groupActive comparator 1 intervention

Trial outcomes

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).

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

Secondary outcomes

1

Range of motion (ROM)

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.

Time frame
Enrollment date, Discharge date(On average, 1 week after admission)
2

Korean Western Ontario & McMaster, K-WOMAC

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.

Time frame
Enrollment date, Discharge date(On average, 1 week after admission), 2 and 4 weeks after admission date
3

EuroQol-5 Dimension (EQ-5D-5L)

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.

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

Patient Global Impression of Change (PGIC)

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.