Tension-Type HeadacheNCT05254028
The Effectiveness of Auricular Point Compared to Body Point Acupuncture Theraphy on Tension-Type Headache
A study testing filiform needle in people with Tension-Type Headache, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The purpose of this study is to compare the effectiveness of manual acupuncture between 2 types of points in decreasing tension-type headache symptoms of healthcare workers in Dr.Cipto Mangunkusumo hospital Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tension-Type Headache
- What is being tested?
- filiform needle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteIndonesia
- Study dates
- 27 Dec 2021to 28 Feb 2022
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthcare workers who work in Dr. Cipto Mangunkusumo hospital
- Age 18-60 years
- Has an episodic or chronic TTH classification and is in accordance with the diagnostic criteria in the International Classification of Headache Disorders 3rd edition beta version (ICHD-3beta)
- Headache with VAS score of 10-70 mm
- Willing to participate in research and sign an informed consent
- Willing to follow the research process to completion.
Who cannot join
- Migraine headaches or secondary headaches
- Long-term (>10 days per month) uninterrupted use of NSAIDs and other analgesia drugs 24 hours before starting acupuncture therapy
- Has contraindications to acupuncture, namely: medical emergencies, pregnancy, history of bleeding disorders (including the use of anticoagulant drugs) obtained from anamnesis history, tumor, or infection at the acupuncture site.
- Ear deformities and earlobe infections
- Fever 38°C
- Have had acupuncture therapy in the last 7 days.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. Cipto Mangunkusumo hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: The Effectiveness of Auricular Point Compared to Body Point Acupuncture Theraphy on Healthcare Workers With Tension-Type Headache in RSUPN Dr. Cipto Mangunkusumo Jakarta
The purpose of this study is to compare the effectiveness of manual acupuncture between 2 types of points in decreasing tension-type headache symptoms of healthcare workers in Dr.Cipto Mangunkusumo hospital
Read the detailed description
The purpose of this study is to compare the effectiveness of manual acupuncture therapy between auricular points and body points in improving tension-type headache symptoms based on a headache diary which is consisting of intensity and frequency of headache days, a short form-36 questionnaire, and an examination of the press pressure threshold on eight pericranial muscles. If the use of auricular points is proven to be superior, then this method will benefit the patient more because it is more efficient and can be used as a protocol for providing therapy to patients with tension-type headache.
- Conditions
- Tension-Type Headache
- Being tested
- filiform needle
- Keywords
- Acupuncture, Auricular acupuncture, Tension-type headache, Healthcare worker
- 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.
filiform needleProcedure or surgery
Manual acupuncture using filiform needles
| Study group | Role | What they receive |
|---|---|---|
| Auricular points acupuncture | Active comparator | The subject of this study is healthcare workers with tension-type headache symptoms who work at Dr. Cipto Mangunkusumo Hospital. The subject of this group will be treated with filiform needles, 30-minute needle retention, 3 times a week for 2 weeks (total of 6 therapy sessions). The "Huanqiu" needles with a size 0.20mm x 13mm are inserted at the auricular acupuncture points shenmen (TF4), thalamus (AT4), and occiput (AT3) bilateral. Receives: Procedure: filiform needle |
| Body points acupuncture | Active comparator | The subject of this study is healthcare workers with tension-type headache symptoms who work at Dr. Cipto Mangunkusumo Hospital. The subject of this group will be treated with filiform needles, 30-minute needle retention, 3 times a week for 2 weeks (total of 6 therapy sessions). The "Huanqiu" needles with a size 0.25mm x 25mm are inserted at the acupuncture points LI4 Hegu, LR3 Taichong, dan GB20 Fengchi bilateral. Receives: Procedure: filiform needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache intensity
Headache intensity is recorded in the headache diary, measured by a visual analog score (VAS) consisting of a straight horizontal line numbered 0-100 millimeters (mm) and a description at each end (no pain at 0 mm and very severe pain at 100 mm), then the patient is asked to point a point on the line that corresponds to the degree of pain
Measured: 6 weeks
Frequency of headache day
Frequency of headache day is recorded in the headache diary, as assessed by the presence of headaches > 30 minutes/day.
Measured: 6 weeks
Pain Pressure Threshold (PPT)
PPT is the minimum applied force that can induce pain, in each of 4 bilateral areas: the suboccipital muscle (the insertion of the trapezius muscle), the mid-upper trapezius muscle, the temporal muscle and the splenius capitis muscle. Measurements using the "Weigner" algometer. Measurements in one area were carried out 3 times, with the result being the average of the three.
Measured: 2 weeks
Short form-36 questionnaire (SF-36)
SF-36 is a questionnaire to assess a person's quality of life which consists of 36 questions divided into 8 scales with the results of 2 summary measures, namely physical and mental health. Assessments were carried out using the SF-36 software for scores ranging from 0-100 (0=worst state of health and 100=best state of health). The mean score of 50 was articulated as the normative value for all scales
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start27 Dec 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tension-Type HeadacheStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fieka Meitaqwatiningarum, Universitas Indonesia
- Investigators
- Fieka Meitaqwatiningarum, dr, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254028
- Sponsor's protocol ID
- 21-10-1106
- Status last verified
- Mar 2022
- First submitted
- 29 Jan 2022
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Auricular Point Compared to Body Point Acupuncture Theraphy on Healthcare Workers With Tension-Type Headache in RSUPN Dr. Cipto Mangunkusumo Jakarta
- ClinicalTrials.gov ID
- NCT05254028
- Acronym / sponsor ID
- 21-10-1106
- Conditions
- Tension-Type Headache
- Keywords
- Acupuncture, Auricular acupuncture, Tension-type headache, Healthcare worker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 27 Dec 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 24 Feb 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.
The purpose of this study is to compare the effectiveness of manual acupuncture between 2 types of points in decreasing tension-type headache symptoms of healthcare workers in Dr.Cipto Mangunkusumo hospital
Detailed description
The purpose of this study is to compare the effectiveness of manual acupuncture therapy between auricular points and body points in improving tension-type headache symptoms based on a headache diary which is consisting of intensity and frequency of headache days, a short form-36 questionnaire, and an examination of the press pressure threshold on eight pericranial muscles. If the use of auricular points is proven to be superior, then this method will benefit the patient more because it is more efficient and can be used as a protocol for providing therapy to patients with tension-type headache.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular points acupuncture | Active comparator | Procedure: filiform needleThe subject of this study is healthcare workers with tension-type headache symptoms who work at Dr. Cipto Mangunkusumo Hospital. The subject of this group will be treated with filiform needles, 30-minute needle retention, 3 times a week for 2 weeks (total of 6 therapy sessions). The "Huanqiu" needles with a size 0.20mm x 13mm are inserted at the auricular acupuncture points shenmen (TF4), thalamus (AT4), and occiput (AT3) bilateral. |
| Body points acupuncture | Active comparator | Procedure: filiform needleThe subject of this study is healthcare workers with tension-type headache symptoms who work at Dr. Cipto Mangunkusumo Hospital. The subject of this group will be treated with filiform needles, 30-minute needle retention, 3 times a week for 2 weeks (total of 6 therapy sessions). The "Huanqiu" needles with a size 0.25mm x 25mm are inserted at the acupuncture points LI4 Hegu, LR3 Taichong, dan GB20 Fengchi bilateral. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthcare workers who work in Dr. Cipto Mangunkusumo hospital
- Age 18-60 years
- Has an episodic or chronic TTH classification and is in accordance with the diagnostic criteria in the International Classification of Headache Disorders 3rd edition beta version (ICHD-3beta)
- Headache with VAS score of 10-70 mm
- Willing to participate in research and sign an informed consent
Key exclusion criteria (6 listed)
- Migraine headaches or secondary headaches
- Long-term (>10 days per month) uninterrupted use of NSAIDs and other analgesia drugs 24 hours before starting acupuncture therapy
- Has contraindications to acupuncture, namely: medical emergencies, pregnancy, history of bleeding disorders (including the use of anticoagulant drugs) obtained from anamnesis history, tumor, or infection at the acupuncture site.
- Ear deformities and earlobe infections
- Fever 38°C
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 |
|---|---|---|
| filiform needleManual acupuncture using filiform needles | Procedure or surgery | Auricular points acupuncture, Body points acupuncture |
Primary outcome
Headache intensity
Time frame: 6 weeks
Headache intensity is recorded in the headache diary, measured by a visual analog score (VAS) consisting of a straight horizontal line numbered 0-100 millimeters (mm) and a description at each end (no pain at 0 mm and very severe pain at 100 mm), then the patient is asked to point a point on the line that corresponds to the degree of pain
Frequency of headache day
Time frame: 6 weeks
Frequency of headache day is recorded in the headache diary, as assessed by the presence of headaches > 30 minutes/day.
Pain Pressure Threshold (PPT)
Time frame: 2 weeks
PPT is the minimum applied force that can induce pain, in each of 4 bilateral areas: the suboccipital muscle (the insertion of the trapezius muscle), the mid-upper trapezius muscle, the temporal muscle and the splenius capitis muscle. Measurements using the "Weigner" algometer. Measurements in one area were carried out 3 times, with the result being the average of the three.
Short form-36 questionnaire (SF-36)
Time frame: 6 weeks
SF-36 is a questionnaire to assess a person's quality of life which consists of 36 questions divided into 8 scales with the results of 2 summary measures, namely physical and mental health. Assessments were carried out using the SF-36 software for scores ranging from 0-100 (0=worst state of health and 100=best state of health). The mean score of 50 was articulated as the normative value for all scales
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 22 Mar 2022.
Related trials for Tension-Type Headache
Recruiting
Efficacy and Safety of Ultrasound-Guided Pharmacopuncture as an Adjunctive Therapy in Inpatients With Post-Traffic Accident Tension-Type Headache
Pharmacologic Action
RecruitingPhase 4
Treatment of Tension-type Headache by Zhixuan Analgesic Tablets
Frequent Episodic Tension-Type Headache
Not yet recruitingObservational study
Prevalence of Primary Headache in Multiple Sclerosis Patients
Multiple Sclerosis, Primary Headache Disorders
Not yet recruitingObservational study
Tension-type Headache and Its Association
Tension-Type Headache, Sleep Disturbance
Recruiting
High- vs Standard-Dose Intravenous Magnesium for Acute Headache
Acute Headache, Migraine
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.
Fieka Meitaqwatiningarum, dr principal investigator
Fakultas Kedokteran Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing filiform needle in people with Tension-Type Headache, run by Universitas Indonesia at 1 site in Indonesia.
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 6 inclusion and 6 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 22 Mar 2022. 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 Indonesia. 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?
Headache intensity (time frame: 6 weeks). The study lists 4 primary outcomes in all. 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 22 Mar 2022.