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Completed

NCT Number: NCT05254028

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

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

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Key information

Conditions

Tension-type Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Cipto Mangunkusumo hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

filiform needle

Procedure

Manual acupuncture using filiform needles

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 24, 2022
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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