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

NCT05254028 | Completed

• 1 other identifier: 21-10-1106
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Conditions

Tension-Type Headache

Keywords

Acupuncture; Auricular acupuncture; Tension-type headache; Healthcare worker

Outcome Measures

Primary Outcomes (4)

• 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

  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.

  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.

  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

  6 weeks

Study Arms (2)

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.

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.

Procedure: filiform needle

Interventions

filiform needle PROCEDURE

Manual acupuncture using filiform needles

Auricular points acupuncture; Body points acupuncture

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Dr. Cipto Mangunkusumo hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Tension-Type Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Fieka Meitaqwatiningarum, dr

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: There will be 4 outcome assessors who do not know the intervention status of study subjects
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 29, 2022
• First Posted: February 24, 2022
• Study Start: December 27, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: March 22, 2022

Record last verified: 2022-03

Locations

ID (1)