Investigating the Impact of Acupuncture on the Quality of Life of Primitive Headaches Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChang Gung Memorial Hospital

About this trial

Primary headache is one of the most common neurological diseases in modern society, which seriously affects the patient's quality of life. Although the use of painkillers can alleviate primary headache symptoms, it may also cause drug dependence. Therefore, alternative therapies that do not rely on drugs have attracted increasing attention in recent years. Among them, acupuncture has been partially recognized by the public as an effective treatment for primary headaches. However, there is currently no scientific evidence that acupuncture is effective for primary headaches. The purpose of this project is to verify the effect of acupuncture in treating primary headaches. This study has three sub-projects:

Subproject 2 explores the impact of acupuncture on headache severity and quality of life in patients with primary headaches. We evaluate the quality of life before and after acupuncture treatment through professional questionnaires, including the Numerical rating scale (NRS), headache diary, depression, anxiety and stress scale (DASS-21), health quality of life measurement questionnaire, Migraine Disability Assessment Scale and SF-36 Taiwan version. Finally, these data will be combined with the pulseway analysis from the results of sub-project 1 to provide a comprehensive way to evaluate the treatment effect.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Willing to sign a written subject consent form

Male or female over 18 years old

Those who have headaches (for example: dizziness, heavy head, dizziness, head fullness, migraine), those who have headaches more than twice a week, and whose NRS score is ˃ 4.

Headache definition: Headache symptoms are classified according to the ICHD-3 headache classification of the International Headache Organization, and are mainly primary headaches.

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • Real acupuncture

    Other intervention

    Real acupuncture twice a week for two weeks

  • Sham acupuncture

    Other intervention

    Sham acupuncture twice a week for two weeks

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: acupunctureExperimental treatment 2 interventions
Group B: sham acupunctureSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Numerical rating scale

Numerical rating scale (NRS) is the most commonly used pain intensity assessment tool at home and abroad. A straight line that is actually 10 centimeters, marked with "0" on the far left and "10" on the far right. Explain to the patient that "0" means no pain and "10" means very painful. The pain level increases from left to right, so that the patient can Draw vertically with a pen a few centimeters where the pain feels and record it in centimeters. You can also simply explain to the patient orally the meaning represented by "0" to "10" and let the patient rate it (verbal rating).

Time frame
2 minutes
2

The Depression, Anxiety and Stress Scale (DASS-21),

The Depression, Anxiety and Stress Scale (DASS-21), also known as the "Self-Rating Emotion Scale" is a self-report scale that effectively assesses depression, anxiety and stress levels of the general population; it has 21 questions in total and takes time About 5 minutes. Although this scale cannot replace professional clinical diagnosis, nor can it be used as a basis for diagnosis alone, it has a significant screening effect on minor mental health problems.

Time frame
7minutes
3

Europe health-related quality of life questionnaire 5 dimensions (EQ-5D)

Europe health-related quality of life questionnaire 5 dimensions (EQ-5D) is a preference-based health life quality measurement tool. It includes 5 self-classifier questions and 0 - Two parts including a 100-point self-assessment scale for current health status.

Time frame
7minutes
4

The headache diary

The headache diary is to record your own headache diary every day, which can make it easier to communicate with the doctor about your pain condition and help the doctor treat primary headaches.

Time frame
20minutes

Secondary outcomes

Other outcomes

Sponsors and contacts

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