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The Effectiveness of Pharmacopuncture on Acute Tension Headache

Primary Purpose

Tension Headache

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pharmacopuncture
Korean medical treatment
Sponsored by
Jaseng Medical Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tension Headache

Eligibility Criteria

19 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jaseng Hospital of Korean Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pharmacopucture on suboccipital muscles

Korean medical treatment

Arm 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.

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

Outcomes

Primary Outcome Measures

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'.

Secondary Outcome Measures

Numeric Rating Scale(NRS) of Neck pain
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 leg pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
Headache Disability Index(HDI)
The HDI is a 25-item, self-report headache disability measure that has good internal consistency reliability and strong long-term test-retest stability.
Headache Impact Test-6(HIT-6)
The HIT-6 items measure the adverse impact of headache on social functioning, role functioning, vitality, cognitive functioning and psychological distress. The HIT-6 also measures the severity of headache pain.
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
The EQ-5D is a method of indirectly calculating the weights of certain health states for quality of life after a multidimensional investigation of health states, and is the most widely used instrument for this purpose. The EQ-5D consists of 5 questions about current health state (mobility, self-care, usual activities, pain, anxiety/depression), and each question is scored on a 5-point Likert scale (1=no problems, 3=moderate problems, 5=severe problems). In this study, the investigators will use the Korean version of the EQ-5D, which has been demonstrated to be valid.
Patient Global Impression of Change(PGIC)
The PGIC is an index that assesses improvements in functional limitation caused by whiplash injury. Participants rate the improvement in functional limitations after treatment on a 7-point Likert scale (1=Very much improved, 4=No change, 7=Very much worse). This index was originally developed for use in Psychology, but is currently used in various other medical fields to assess improvements in pain.

Full Information

First Posted
September 18, 2022
Last Updated
October 6, 2023
Sponsor
Jaseng Medical Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05549765
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 8, 2022 (Actual)
Primary Completion Date
April 4, 2023 (Actual)
Study Completion Date
April 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jaseng Medical Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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)."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tension Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pharmacopucture on suboccipital muscles
Arm Type
Experimental
Arm 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.
Arm Title
Korean medical treatment
Arm Type
Active Comparator
Arm Description
The control group will be received Korean medical treatment everyday after hospitalization: acupuncture(except on suboccipital parts), chuna, pharmacoacupuncture and Korean herbal medicine
Intervention Type
Procedure
Intervention Name(s)
Pharmacopuncture
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
Korean medical treatment
Intervention Description
acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine
Primary Outcome Measure Information:
Title
Numeric Rating Scale(NRS) of headache
Description
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'.
Time Frame
Change from baseline NRS at 4 days
Secondary Outcome Measure Information:
Title
Numeric Rating Scale(NRS) of Neck pain
Description
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 leg pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
Time Frame
Baseline(day2), day3, day4, day of discharge(up to 14days), week 8
Title
Headache Disability Index(HDI)
Description
The HDI is a 25-item, self-report headache disability measure that has good internal consistency reliability and strong long-term test-retest stability.
Time Frame
Baseline(day2), day4, day of discharge(up to 14days), week 8
Title
Headache Impact Test-6(HIT-6)
Description
The HIT-6 items measure the adverse impact of headache on social functioning, role functioning, vitality, cognitive functioning and psychological distress. The HIT-6 also measures the severity of headache pain.
Time Frame
Baseline(day2), day4, day of discharge(up to 14days), week 8
Title
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Description
The EQ-5D is a method of indirectly calculating the weights of certain health states for quality of life after a multidimensional investigation of health states, and is the most widely used instrument for this purpose. The EQ-5D consists of 5 questions about current health state (mobility, self-care, usual activities, pain, anxiety/depression), and each question is scored on a 5-point Likert scale (1=no problems, 3=moderate problems, 5=severe problems). In this study, the investigators will use the Korean version of the EQ-5D, which has been demonstrated to be valid.
Time Frame
Baseline(day2), day4, day of discharge(up to 14days), week 8
Title
Patient Global Impression of Change(PGIC)
Description
The PGIC is an index that assesses improvements in functional limitation caused by whiplash injury. Participants rate the improvement in functional limitations after treatment on a 7-point Likert scale (1=Very much improved, 4=No change, 7=Very much worse). This index was originally developed for use in Psychology, but is currently used in various other medical fields to assess improvements in pain.
Time Frame
day4, day of discharge(up to 14days), week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Hyuk Ha, phD
Organizational Affiliation
Jaseng Medical Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jaseng Hospital of Korean Medicine
City
Seoul
State/Province
Gangnam-Gu
ZIP/Postal Code
135-896
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effectiveness of Pharmacopuncture on Acute Tension Headache

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