Tension HeadacheNCT05549765
The Effectiveness of Pharmacopuncture on Acute Tension Headache
A study testing Pharmacopuncture and Korean medical treatment in people with Tension Headache, run by Jaseng Medical Foundation at 1 site in South Korea.
Trial summary
This study is a double blind, randomized controlled trail. condition/disease: acute tension headache treatment/intervention: Pharmacopuncture Read more about this study
- Who is it for?
- Ages 19 to 69 years
- Conditions the study is for
- Tension Headache
- What is being tested?
- Pharmacopuncture and Korean medical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Sep 2022to 4 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, 135-896
About this study
Official title: The Effectiveness and Safety of Pharmacopuncture on Inpatients With Tension Headache Caused by Traffic Accidents: A Pragmatic Randomized Controlled Trial
This study is a double blind, randomized controlled trail. condition/disease: acute tension headache treatment/intervention: Pharmacopuncture
Read the 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
- Being tested
- Pharmacopuncture, Korean medical treatment
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PharmacopunctureProcedure or surgery
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 treatmentProcedure or surgery
acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Korean medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: Change from baseline NRS at 4 days
Secondary outcomes (5)
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'.
Measured: Baseline(day2), day3, day4, day of discharge(up to 14days), week 8
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.
Measured: Baseline(day2), day4, day of discharge(up to 14days), week 8
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.
Measured: Baseline(day2), day4, day of discharge(up to 14days), week 8
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.
Measured: Baseline(day2), day4, day of discharge(up to 14days), week 8
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.
Measured: day4, day of discharge(up to 14days), week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start8 Sep 2022
- Primary completion4 Apr 2023
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tension HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Hyuk Ha, KMD, Jaseng Medical Foundation
- Investigators
- In-Hyuk Ha, phD, Principal investigator, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549765
- Sponsor's protocol ID
- JS-CT-2022-11
- Status last verified
- Oct 2023
- First submitted
- 18 Sep 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Safety of Pharmacopuncture on Inpatients With Tension Headache Caused by Traffic Accidents: A Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05549765
- Acronym / sponsor ID
- JS-CT-2022-11
- Conditions
- Tension Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacopucture on suboccipital muscles | Experimental | Procedure: Pharmacopuncture, Procedure: Korean medical treatmentThe 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. |
| Korean medical treatment | Active comparator | Procedure: Korean medical treatmentThe control group will be received Korean medical treatment everyday after hospitalization: acupuncture(except on suboccipital parts), chuna, pharmacoacupuncture and Korean herbal medicine |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PharmacopuncturePharmacopuncture 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. | Procedure or surgery | Pharmacopucture on suboccipital muscles |
| Korean medical treatmentacupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine | Procedure or surgery | Korean medical treatment, Pharmacopucture on suboccipital muscles |
Primary outcome
Numeric Rating Scale(NRS) of headache
Time frame: Change from baseline NRS at 4 days
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'.
5 secondary outcomes
Numeric Rating Scale(NRS) of Neck pain
Time frame: Baseline(day2), day3, day4, day of discharge(up to 14days), week 8
Headache Disability Index(HDI)
Time frame: Baseline(day2), day4, day of discharge(up to 14days), week 8
Headache Impact Test-6(HIT-6)
Time frame: Baseline(day2), day4, day of discharge(up to 14days), week 8
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Time frame: Baseline(day2), day4, day of discharge(up to 14days), week 8
Patient Global Impression of Change(PGIC)
Time frame: day4, day of discharge(up to 14days), week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In-Hyuk Ha, phD principal investigator
Jaseng Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacopuncture and Korean medical treatment in people with Tension Headache, run by Jaseng Medical Foundation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale(NRS) of headache (time frame: Change from baseline NRS at 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.