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

Tension-Type Headache Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05254028
• Other study ID #: 21-10-1106
• Status: Completed
• Phase: N/A
• Start date: December 27, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2022
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Tension-Type Headache

Intervention

Procedure:
• filiform needle
Manual acupuncture using filiform needles

Locations

Country	Name	City	State
Indonesia	Dr. Cipto Mangunkusumo hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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