Pharmacologic ActionNCT07893496
Efficacy and Safety of Ultrasound-Guided Pharmacopuncture as an Adjunctive Therapy in Inpatients With Post-Traffic Accident Tension-Type Headache
A study testing Cervicocranial ultrasound-guided pharmacopuncture 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 ultrasound-guided pharmacopuncture for patients with tension-type headache caused by a traffic accident. It is a pragmatic clinical study to confirm the comparative effectiveness by comparing the strategy of combining ultrasound-guided… 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?
- Cervicocranial ultrasound-guided pharmacopuncture 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
- 3 Oct 2026to 31 Dec 2027
- 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
- Patients hospitalized for the treatment of traffic accidents with tension-type headache originating from a traffic accident within 14 days of onset.
- Patients with a headache NRS (Numeric Rating Scale) score of 5 or higher.
- Patients diagnosed with tension-type headache according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria:
- Headache exhibiting at least two of the following characteristics:
- Bilateral location
- Pressing or tightening (non-pulsating) quality
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- Mild or moderate intensity
- Not aggravated by routine physical activity such as walking or climbing stairs
- Fulfilling both of the following conditions:
- No nausea or vomiting
- No more than one of photophobia or phonophobia
- Patients aged between 19 and 69 years old (aged 19 to less than 70 years).
- Participants who voluntarily decide to participate, fully understand the details of the clinical study, agree to follow precautions, and provide written informed consent.
Who cannot join
- Patients diagnosed with specific serious medical conditions requiring surgical management rather than conservative treatment (e.g., acute fracture, dislocation, complete ligament rupture, etc.).
- Cases where the cause of pain originates from conditions other than tension-type headache (e.g., intracerebral hemorrhage, cerebral infarction, hypertension, ocular diseases, drug-induced headache, etc.).
- Cases where surgical intervention is required due to suspected acute cervical spine fracture, herniated cervical disc, or spinal ligament injury.
- Patients diagnosed with primary headache disorders other than tension-type headache, such as migraine or cluster headache.
- Patients with other acute diseases (e.g., stroke, myocardial infarction, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.) that may interfere with the treatment effect or interpretation of study results.
- Patients currently taking steroids, immunosuppressants, psychiatric medications, or other drugs that may affect the study findings.
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- Cases where pharmacopuncture treatment is inadequate or unsafe: patients with hemorrhagic diseases, those receiving anticoagulant therapy, or severe diabetic patients with a risk of infection.
- Patients who have taken medications that may affect pain, such as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), or have received pharmacopuncture or physical therapy within the past 1 week.
- Pregnant women, women who are planning to become pregnant, or nursing mothers.
- Patients within 3 months following head or neck-related surgery.
- Patients who finished participating in another clinical study less than 1 month prior, or who plan to participate in another clinical study during the study and follow-up period within 6 months from the date of selection.
- Cases where it is difficult to obtain written informed consent for participation.
- Other cases where the investigator deems the candidate unsuitable for participation in the clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Seung Jeon, KMD contact
South Korea1 site, 1 recruiting
- Recruiting
Daejeon Jaseng Hospital of Korean Medicine, Daejeon
Daejeon
SEUNG JEON, KMD, 82-010--4138-8199, 3eung16@jaseng.org
About this study
Official title: Efficacy and Safety of Ultrasound-Guided Pharmacopuncture as an Adjunctive Therapy in Inpatients With Post-Traffic Accident Tension-Type Headache: A Randomized Controlled Pragmatic Pilot Trial
The purpose of this study is to reveal the effectiveness and safety of ultrasound-guided pharmacopuncture for patients with tension-type headache caused by a traffic accident. It is a pragmatic clinical study to confirm the comparative effectiveness by comparing the strategy of combining ultrasound-guided pharmacopuncture in parallel with the strategy of treating with integrative Korean medicine treatment, which is an existing treatment method.
- Conditions
- Pharmacologic Action
- Being tested
- Cervicocranial ultrasound-guided pharmacopuncture, Oriental medicine integrated treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervicocranial ultrasound-guided pharmacopunctureProcedure or surgery
Also called Drug: Herbal extract-based pharmacopuncture
Integrative Korean medicine treatment combined with cervicocranial ultrasound-guided pharmacopuncture. The physician chooses the adequate type and dose of pharmacopuncture, needle type, and target anatomical structures under ultrasound guidance.
Oriental medicine integrated treatmentProcedure or surgery
Also called Device: Acupuncture needles, herbal medicine, non-ultrasound guided pharmacopuncture, Chuna manual therapy, cupping devices, and moxibustion devices, etc.
Conventional integrative Korean medicine treatment comprising acupuncture, herbal medicine, pharmacopuncture, Chuna manual therapy, and other modalities (cupping, moxibustion, etc.). The physician selects the appropriate combination of treatments based on clinical judgment.
| Study group | Role | What they receive |
|---|---|---|
| Cervicocranial ultrasound-guided pharmacopuncture group | Experimental | 20 patients in the Cervicocranial ultrasound-guided pharmacoapuncture Receives: Procedure: Cervicocranial ultrasound-guided pharmacopuncture |
| Oriental medicine integrated treatment | 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.
Headache numeric rating scale (NRS)
The intensity of Headache 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 2week, 4 weeks and 8 weeks after admission date
Secondary outcomes (5)
Neck pain numeric rating scale (NRS)
The intensity of Neck 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 2week, 4 weeks and 8 weeks after admission date
Headache Disability Index (HDI)
The physical and emotional disability experienced by participants due to headache will be assessed to evaluate changes before and after treatment. It consists of a total of 25 items, with each item following the standardized scoring method of the original questionnaire tool (Yes = 4 points, Sometimes = 2 points, No = 0 points). The total score obtained through the survey reflects the degree of daily life restriction and quality of life due to headache, with higher scores indicating a greater degree of disability.
Measured: through admission completion, an average of 2week, 4 weeks and 8 weeks after admission date
Headache Impact Test (HIT-6)
The functional status and impact of headache on daily life will be assessed using the Headache Impact Test-6 (HIT-6). The HIT-6 is a 6-item questionnaire, with each item scored on a 5-point scale (Never = 6, Rarely = 8, Sometimes = 10, Very often = 11, Always = 13). The total score ranges from 36 to 78, where 36 indicates little to no impact and 78 indicates severe impact. A higher score indicates a worse outcome (greater headache severity and functional disability).
Measured: through admission completion, an average of 2week, 4 weeks and 8 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, 2, 4 and 8 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: 8days, 2, 4, 8 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 posted26 Oct 2026
- Study start3 Oct 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (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
- NCT07893496
- Sponsor's protocol ID
- JS-CT-2026-02
- Status last verified
- Sep 2026
- First submitted
- 12 Oct 2026
- Last updated
- 26 Oct 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ultrasound-Guided Pharmacopuncture as an Adjunctive Therapy in Inpatients With Post-Traffic Accident Tension-Type Headache: A Randomized Controlled Pragmatic Pilot Trial
- ClinicalTrials.gov ID
- NCT07893496
- Acronym / sponsor ID
- JS-CT-2026-02
- Conditions
- Pharmacologic Action
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 3 Oct 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Oct 2026 (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 ultrasound-guided pharmacopuncture for patients with tension-type headache caused by a traffic accident. It is a pragmatic clinical study to confirm the comparative effectiveness by comparing the strategy of combining ultrasound-guided pharmacopuncture in parallel with the strategy of treating with integrative Korean 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 |
|---|---|---|
| Cervicocranial ultrasound-guided pharmacopuncture group | Experimental | Procedure: Cervicocranial ultrasound-guided pharmacopuncture20 patients in the Cervicocranial ultrasound-guided pharmacoapuncture |
| Oriental medicine integrated treatment | 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 (13 listed)
- Patients hospitalized for the treatment of traffic accidents with tension-type headache originating from a traffic accident within 14 days of onset.
- Patients with a headache NRS (Numeric Rating Scale) score of 5 or higher.
- Patients diagnosed with tension-type headache according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria:
- Headache exhibiting at least two of the following characteristics:
- Bilateral location
Key exclusion criteria (13 listed)
- Patients diagnosed with specific serious medical conditions requiring surgical management rather than conservative treatment (e.g., acute fracture, dislocation, complete ligament rupture, etc.).
- Cases where the cause of pain originates from conditions other than tension-type headache (e.g., intracerebral hemorrhage, cerebral infarction, hypertension, ocular diseases, drug-induced headache, etc.).
- Cases where surgical intervention is required due to suspected acute cervical spine fracture, herniated cervical disc, or spinal ligament injury.
- Patients diagnosed with primary headache disorders other than tension-type headache, such as migraine or cluster headache.
- Patients with other acute diseases (e.g., stroke, myocardial infarction, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.) that may interfere with the treatment effect or interpretation of study results.
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 |
|---|---|---|
| Cervicocranial ultrasound-guided pharmacopunctureAlso: Drug: Herbal extract-based pharmacopunctureIntegrative Korean medicine treatment combined with cervicocranial ultrasound-guided pharmacopuncture. The physician chooses the adequate type and dose of pharmacopuncture, needle type, and target anatomical structures under ultrasound guidance. | Procedure or surgery | Cervicocranial ultrasound-guided pharmacopuncture group |
| Oriental medicine integrated treatmentAlso: Device: Acupuncture needles, herbal medicine, non-ultrasound guided pharmacopuncture, Chuna manual therapy, cupping devices, and moxibustion devices, etc.Conventional integrative Korean medicine treatment comprising acupuncture, herbal medicine, pharmacopuncture, Chuna manual therapy, and other modalities (cupping, moxibustion, etc.). The physician selects the appropriate combination of treatments based on clinical judgment. | Procedure or surgery | Oriental medicine integrated treatment |
Primary outcome
Headache numeric rating scale (NRS)
Time frame: through admission completion, an average of 2week, 4 weeks and 8 weeks after admission date
The intensity of Headache 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).
5 secondary outcomes
Neck pain numeric rating scale (NRS)
Time frame: through admission completion, an average of 2week, 4 weeks and 8 weeks after admission date
Headache Disability Index (HDI)
Time frame: through admission completion, an average of 2week, 4 weeks and 8 weeks after admission date
Headache Impact Test (HIT-6)
Time frame: through admission completion, an average of 2week, 4 weeks and 8 weeks after admission date
EuroQol-5 Dimension (EQ-5D-5L)
Time frame: Enrollment date, 2, 4 and 8 weeks after admission date
Patient Global Impression of Change (PGIC)
Time frame: 8days, 2, 4, 8 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 26 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Seung Jeon, KMD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervicocranial ultrasound-guided pharmacopuncture 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 13 inclusion and 13 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 26 Oct 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 Sujin Kim, KMD (82-010-5527-2015, naldo15@jaseng.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache numeric rating scale (NRS) (time frame: through admission completion, an average of 2week, 4 weeks and 8 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 26 Oct 2026.