Pharmacologic ActionNCT06931951
The Effectiveness and Safety of Pharmacopuncture on Inpatients With Acute Knee Pain Caused by Traffic Accidents
A study testing Knee Pharmacoacupuncture and Oriental medicine integrated treatment in people with Pharmacologic Action, run by Jaseng Medical Foundation at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 69 years
- Conditions the study is for
- Pharmacologic Action
- What is being tested?
- Knee Pharmacoacupuncture and Oriental medicine integrated treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 May 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Daejeon Jaseng Hospital of Korean Medicine
Daejeon
EUNYUL HAN, KMD, 82-010-4440-3499, yul123@jaseng.org
About this study
Official title: 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.
- Conditions
- Pharmacologic Action
- Being tested
- Knee Pharmacoacupuncture, Oriental medicine integrated treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee PharmacoacupunctureProcedure or surgery
Also called Drug: Herbal extract-based pharmacopuncture
Physician choose the adequate type and dose of pharmacoacupuncture and needle type
Oriental medicine integrated treatmentProcedure or surgery
Also called Device: Acupuncture needles, cupping devices, and moxibustion devices, etc.
Physician choose the integrated oriental medicine treatment other than herbal acupuncture.
| Study group | Role | What they receive |
|---|---|---|
| Knee Pharmacoacupuncture group | Experimental | 20 patients in the Knee Pharmacoacupuncture group Receives: Procedure: Knee Pharmacoacupuncture |
| Oriental medicine integrated treatment group | Active comparator | 20 patients in the Oriental medicine integrated treatment group Receives: Procedure: Oriental medicine integrated treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: through admission completion, an average of 1week, 2 weeks and 4 weeks after admission date
Secondary outcomes (4)
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.
Measured: Enrollment date, Discharge date(On average, 1 week after admission)
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.
Measured: Enrollment date, Discharge date(On average, 1 week after admission), 2 and 4 weeks after admission date
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.
Measured: Enrollment date, Discharge date(On average, 1 week after admission), 2 and 4 weeks after admission date
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.
Measured: Discharge date(On average, 1 week after admission), 2 and 4 weeks after admission date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start22 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacologic ActionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931951
- Sponsor's protocol ID
- JS-CT-2025-02
- Status last verified
- Jan 2026
- First submitted
- 12 Mar 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Safety of Pharmacopuncture on Inpatients With Acute Knee Pain Caused by Traffic Accidents : A Pragmatic Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT06931951
- Acronym / sponsor ID
- JS-CT-2025-02
- Conditions
- Pharmacologic Action
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 22 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Knee Pharmacoacupuncture group | Experimental | Procedure: Knee Pharmacoacupuncture20 patients in the Knee Pharmacoacupuncture group |
| Oriental medicine integrated treatment group | Active comparator | Procedure: Oriental medicine integrated treatment20 patients in the Oriental medicine integrated treatment group |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Knee PharmacoacupunctureAlso: Drug: Herbal extract-based pharmacopuncturePhysician choose the adequate type and dose of pharmacoacupuncture and needle type | Procedure or surgery | Knee Pharmacoacupuncture group |
| Oriental medicine integrated treatmentAlso: Device: Acupuncture needles, cupping devices, and moxibustion devices, etc.Physician choose the integrated oriental medicine treatment other than herbal acupuncture. | Procedure or surgery | Oriental medicine integrated treatment group |
Primary outcome
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).
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Pharmacologic Action
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in Europe (PLATINUM EU)
Neuromuscular Agents, Peripheral Nervous System Agents
RecruitingObservational study
Natural History of Depression, Bipolar Disorder and Suicide Risk
Behavioral Symptoms, Suicide
Recruiting
Efficacy and Safety of Ultrasound-Guided Pharmacopuncture as an Adjunctive Therapy in Inpatients With Post-Traffic Accident Tension-Type Headache
Pharmacologic Action
RecruitingPhase 3
A Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD)
Alpha 1 Antitrypsin Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knee Pharmacoacupuncture and Oriental medicine integrated treatment in people with Pharmacologic Action, run by Jaseng Medical Foundation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sunah Kim KMD (82-42-1577-0007, tnsdk2648@jaseng.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee pain numeric rating scale (NRS) (time frame: through admission completion, an average of 1week, 2 weeks and 4 weeks after admission date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.