The Effectiveness of Auricular Point Compared to Body Point Acupuncture Theraphy on Tension-Type Headache

NCT ID: NCT05254028

Last Updated: 2022-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-27

Study Completion Date

2022-02-28

Brief Summary

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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

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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

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Tension-Type Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
There will be 4 outcome assessors who do not know the intervention status of study subjects

Study Groups

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Auricular points acupuncture

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.

Group Type ACTIVE_COMPARATOR

filiform needle

Intervention Type PROCEDURE

Manual acupuncture using filiform needles

Body points acupuncture

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.

Group Type ACTIVE_COMPARATOR

filiform needle

Intervention Type PROCEDURE

Manual acupuncture using filiform needles

Interventions

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filiform needle

Manual acupuncture using filiform needles

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Fieka Meitaqwatiningarum

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fieka Meitaqwatiningarum, dr

Role: PRINCIPAL_INVESTIGATOR

Fakultas Kedokteran Universitas Indonesia

Locations

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Dr. Cipto Mangunkusumo hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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21-10-1106

Identifier Type: -

Identifier Source: org_study_id

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