Clinical trial NCT05549765: The Effectiveness of Pharmacopuncture on Acute Tension Headache
Official title: The Effectiveness and Safety of Pharmacopuncture on Inpatients With Tension Headache Caused by Traffic Accidents: A Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tension Headache
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a double blind, randomized controlled trail. condition/disease: acute tension headache treatment/intervention: Pharmacopuncture

Detailed description: "Pharmacopuncture is a treatment that combines 2 of the most frequented Korean medicine treatment methods - traditional acupuncture and herbal medicine - by injecting herbal medicine extract at acupoints.

This treatment is known to be an important part of Korean medicine treatment. However, there has been no specific value for the effect of this treatment.

Therefore, the investigators are going to conduct a randomized controlled trials to verify the efficacy and safety of Pharmacopuncture. From September 2022 to December 2023, the investigators are going to collect 80 inpatients who are suffering from Tension headache with the numeric rating scale(NRS) over 5 after injury by acute traffic accident(TA). For experimental group(n=40), the investigators will conduct Pharamacopuncture on suboccpital muscle three times(on 2nd, 3rd and 4th day of hospitalization) and other Korean medical treatment. For control group(n=40), just Korean medical treatment except Pharamacopuncture on suboccpital muscles will be conducted.

For these two groups, the investigators will compare Numeric Rating Scale(NRS) of headache, NRS of Neck pain, Headache Disability Index(HDI), Headache Impact Test-6(HIT-6), EuroQol 5-Dimension (EQ-5D-5L) and Patient Global Impression of Change (PGIC)."

Eligibility criteria: Inclusion Criteria:

* Patients who needs hospitalization due to acute tension headache that occurred within 7 days after traffic accident
* Patients with NRS ≥ 5 for headache
* Patients aged 19-69 years on the date they sign the consent form
* Patients who provide consent to participate in the trial and return the informed consent form

Exclusion Criteria:

* Patients with a specific serious disease that may cause headache: malignancy, cerebral hemorrhage, dural hematoma, etc.
* Patients with progressive neurological deficits or with severe neurological symptoms- Patients who have had surgery or procedures within the last three weeks
* The cause of pain is due to soft tissue disease, not the nerve system disease: trigeminal neuralgia, glossopharyngeal neuralgia, etc.
* Patients with other chronic conditions that may interfere with the interpretation of the therapeutic effects or results: cardiovascular disease, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.
* Patients who are taking steroids, immunosuppressants, mental illness drugs, or other drugs that may affect the results of the study
* If pharmacopuncture and acupuncture is inadequate or unsafe: patients with hemorrhagic, receiving anticoagulants, severe diabetes and cardiovascular disease
* Patients who are pregnant or planning to become pregnant
* Patients with a serious mental illness
* Patients who are participated in clinical trials other than observational studies without therapeutic intervention.
* Patients who are difficult to complete the research participation agreement
* Other patients whose participation in the trial is judged by a researcher to be problematic

Primary outcomes:
measure: Numeric Rating Scale(NRS) of headache
timeFrame: Change from baseline NRS at 4 days
Secondary outcomes:
measure: Numeric Rating Scale(NRS) of Neck pain
timeFrame: Baseline(day2), day3, day4, day of discharge(up to 14days), week 8
measure: Headache Disability Index(HDI)
timeFrame: Baseline(day2), day4, day of discharge(up to 14days), week 8
measure: Headache Impact Test-6(HIT-6)
timeFrame: Baseline(day2), day4, day of discharge(up to 14days), week 8
measure: EuroQol 5-Dimension 5-Level (EQ-5D-5L)
timeFrame: Baseline(day2), day4, day of discharge(up to 14days), week 8
measure: Patient Global Impression of Change(PGIC)
timeFrame: day4, day of discharge(up to 14days), week 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
state: Gangnam-Gu
Study officials:
affiliation: Jaseng Medical Foundation
name: In-Hyuk Ha, phD
role: PRINCIPAL_INVESTIGATOR
References: