The Effectiveness of Pharmacopuncture on Acute Tension Headache

NCT ID: NCT05549765

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-08
• Study Completion Date: 2023-04-04

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)."

Conditions

Tension Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pharmacopucture on suboccipital muscles

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.

Group Type: EXPERIMENTAL

Pharmacopuncture

Intervention Type: PROCEDURE

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.

Korean medical treatment

Intervention Type: PROCEDURE

acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine

Korean medical treatment

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

Group Type: ACTIVE_COMPARATOR

Korean medical treatment

Intervention Type: PROCEDURE

acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine

Interventions

Pharmacopuncture

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.

Intervention Type: PROCEDURE

Korean medical treatment

acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jaseng Medical Foundation

OTHER

Sponsor Role: lead

Responsible Party

In-Hyuk Ha, KMD

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

In-Hyuk Ha, phD

Role: PRINCIPAL_INVESTIGATOR

Jaseng Medical Foundation

Locations

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, South Korea

Countries

South Korea

Other Identifiers

JS-CT-2022-11

Identifier Type: -

Identifier Source: org_study_id