Back to resultsThe Effectiveness of Auricular Point Compared to Body Point Acupuncture Theraphy on Tension-Type Headache
Primary Purpose
Tension-Type Headache
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
filiform needle
Sponsored by
About this trial
This is an interventional treatment trial for Tension-Type Headache focused on measuring Acupuncture, Auricular acupuncture, Tension-type headache, Healthcare worker
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Dr. Cipto Mangunkusumo hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Auricular points acupuncture
Body points acupuncture
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Frequency of headache day
Frequency of headache day is recorded in the headache diary, as assessed by the presence of headaches > 30 minutes/day.
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.
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05254028
Brief Title
The Effectiveness of Auricular Point Compared to Body Point Acupuncture Theraphy on Tension-Type Headache
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 27, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tension-Type Headache
Keywords
Acupuncture, Auricular acupuncture, Tension-type headache, Healthcare worker
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
There will be 4 outcome assessors who do not know the intervention status of study subjects
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Auricular points acupuncture
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Body points acupuncture
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
filiform needle
Intervention Description
Manual acupuncture using filiform needles
Primary Outcome Measure Information:
Title
Headache intensity
Description
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
Time Frame
6 weeks
Title
Frequency of headache day
Description
Frequency of headache day is recorded in the headache diary, as assessed by the presence of headaches > 30 minutes/day.
Time Frame
6 weeks
Title
Pain Pressure Threshold (PPT)
Description
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.
Time Frame
2 weeks
Title
Short form-36 questionnaire (SF-36)
Description
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
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fieka Meitaqwatiningarum, dr
Organizational Affiliation
Fakultas Kedokteran Universitas Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Cipto Mangunkusumo hospital
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
12. IPD Sharing Statement
Learn more about this trial
The Effectiveness of Auricular Point Compared to Body Point Acupuncture Theraphy on Tension-Type Headache
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