ClinicalTrials.gg
RecruitingNCT07893496Updated Oct 26, 2026

Efficacy and Safety of Ultrasound-Guided Pharmacopuncture as an Adjunctive Therapy in Inpatients With Post-Traffic Accident Tension-Type Headache

An interventional study of Cervicocranial ultrasound-guided pharmacopuncture and Oriental medicine integrated treatment in Pharmacologic Action, sponsored by Jaseng Medical Foundation. Recruiting at 1 site in South Korea. Open to participants aged 19 Years to 69 Years. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Jaseng Medical Foundation · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2026; still recruiting 1 month later.
Updated Oct 26, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
19 Years to 69 Years
Sex
All
01

Study 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 pharmacopuncture in parallel with the strategy of treating with integrative Korean medicine treatment, which is an existing treatment method.

02

Conditions studied

  • Pharmacologic Action
03

In context

Lead sponsor

Jaseng Medical Foundation is the lead sponsor of 69 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • 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 .

Exclusion criteria

Exclusion Criteria:

  • 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 , , psychiatric medications, or other drugs that may affect the study findings.
  • 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 for participation.
  • Other cases where the investigator deems the candidate unsuitable for participation in the clinical study.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Cervicocranial ultrasound-guided pharmacopuncture group

    20 patients in the Cervicocranial ultrasound-guided pharmacoapuncture

    Procedure: Cervicocranial ultrasound-guided pharmacopuncture

  • Active comparator
    Oriental medicine integrated treatment

    20 patients in the Oriental medicine integrated treatment group

    Procedure: Oriental medicine integrated treatment

Interventions

  • ProcedureCervicocranial ultrasound-guided 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.

    Also known as: Drug: Herbal extract-based pharmacopuncture

  • ProcedureOriental medicine integrated treatment

    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.

    Also known as: Device: Acupuncture needles, herbal medicine, non-ultrasound guided pharmacopuncture, Chuna manual therapy, cupping devices, and moxibustion devices, etc.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: through admission completion, an average of 2week, 4 weeks and 8 weeks after admission date

Secondary outcomes

  1. 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).

    Time frame: through admission completion, an average of 2week, 4 weeks and 8 weeks after admission date

  2. 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.

    Time frame: through admission completion, an average of 2week, 4 weeks and 8 weeks after admission date

  3. 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).

    Time frame: through admission completion, an average of 2week, 4 weeks and 8 weeks after admission date

  4. 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, 2, 4 and 8 weeks after admission date

  5. 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: 8days, 2, 4, 8 weeks after admission date

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2026 (actual). Primary completion is estimated for Dec 2027, 14 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 12, 2026
First posted
Oct 26, 2026
StartActual
Oct 3, 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07893496
Lead sponsor
Jaseng Medical Foundation
Responsible party
Sponsor
First posted
Oct 26, 2026
Start date
Oct 3, 2026
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Oct 26, 2026

Study contacts

Sujin Kim, KMD
Contact
naldo15@jaseng.org
82-010-5527-2015
Seung Jeon, KMD
Contact
82-010-4138-8199 ext. 3eung16@jaseng

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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