The Effectiveness of Pharmacopuncture on Acute Tension Headache

The Effectiveness and Safety of Pharmacopuncture on Inpatients With Tension Headache Caused by Traffic Accidents: A Pragmatic Randomized Controlled Trial

Sponsors

Lead Sponsor: Jaseng Medical Foundation

Source Jaseng Medical Foundation
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 MSAT 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)."

Overall Status Recruiting
Start Date 2022-09-08
Completion Date 2022-12-31
Primary Completion Date 2022-12-31
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Numeric Rating Scale(NRS) of headache Change from baseline NRS at 4 days
Secondary Outcome
Measure Time Frame
Numeric Rating Scale(NRS) of Neck pain Baseline(day2), day3, day4, day of discharge(up to 14days), week 8
Headache Disability Index(HDI) Baseline(day2), day4, day of discharge(up to 14days), week 8
Headache Impact Test-6(HIT-6) Baseline(day2), day4, day of discharge(up to 14days), week 8
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Baseline(day2), day4, day of discharge(up to 14days), week 8
Patient Global Impression of Change(PGIC) day4, day of discharge(up to 14days), week 8
Enrollment 80
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Pharmacopuncture

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.

Arm Group Label: Pharmacopucture on suboccipital muscles

Intervention Type: Procedure

Intervention Name: Korean medical treatment

Description: acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine

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

Gender:

All

Minimum Age:

19 Years

Maximum Age:

69 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
In-Hyuk Ha, phD Principal Investigator Jaseng Medical Foundation
Overall Contact

Last Name: In-Hyuk Ha, phD

Phone: 02-2222-2740

Phone Ext.: 82

Email: [email protected]

Location
Facility: Status: Contact: Jaseng Hospital of Korean Medicine In-Hyuk Ha +82-2-3218-2249 [email protected]
Location Countries

Korea, Republic of

Verification Date

2022-09-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Jaseng Medical Foundation

Investigator Full Name: In-Hyuk Ha, KMD

Investigator Title: Director

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Pharmacopucture on suboccipital muscles

Type: Experimental

Description: The Pharmacopucture group will recieve 3 sessions of Pharmacopucture on suboccipital muscles; on second, third, fourth day after hospitalization. A trained doctor of Korean medicine with at least 3 years of clinical experience are going to conduct the pharmacopucture. The Pharmacopucture group will also be treated with other Korean medical treatment everyday: acupuncture, chuna and Korean herbal medicine.

Label: Korean medical treatment

Type: Active Comparator

Description: The control group will be received Korean medical treatment everyday after hospitalization: acupuncture(except on suboccipital parts), chuna, pharmacoacupuncture and Korean herbal medicine

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

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