The Effectiveness of Pharmacopuncture on Acute Tension Headache

NCT05549765 | Completed DMC

• 1 other identifier: JS-CT-2022-11
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tension Headache

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale(NRS) of headache

  The extent of headache and discomfort will be assessed by using NRS. NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10. The participant is asked to report their headache and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.

  Change from baseline NRS at 4 days

Secondary Outcomes (5)

• 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

Study Arms (2)

Pharmacopucture on suboccipital muscles

EXPERIMENTAL

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.

Procedure: Pharmacopuncture; Procedure: Korean medical treatment

Korean medical treatment

ACTIVE COMPARATOR

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

Procedure: Korean medical treatment

Interventions

Pharmacopuncture 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.

Pharmacopucture on suboccipital muscles

Korean medical treatment PROCEDURE

acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine

Korean medical treatment; Pharmacopucture on suboccipital muscles

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, 135-896, South Korea

Location

MeSH Terms

Conditions

Tension-Type Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• In-Hyuk Ha, phD

  Jaseng Medical Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 18, 2022
• First Posted: September 22, 2022
• Study Start: September 8, 2022
• Primary Completion: April 4, 2023
• Study Completion: April 4, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)