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

NCT06398353 | Recruiting

• 1 other identifier: 232
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Headache Migraine

Keywords

Headache; Migraine

Outcome Measures

Primary Outcomes (6)

• 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).

  2 minutes

• 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.

  7minutes

• 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.

  7minutes

• 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.

  20minutes

• Migraine Disability Assessment Questionnaire (MIDAs)

  Migraine Disability Assessment Questionnaire (MIDAs) In 1999, Stewart and Lipton proposed the Migraine Disability Assessment Questionnaire (MIDAs). This scale mainly consists of five questions, asking the patient to recall the impact of migraine on schoolwork or work, household affairs, and family, social or leisure activities during the past three months. This questionnaire is also used in Japan, Upper Turkey, Italy and other countries because it is simple and easy to use and has good reliability, validity and objectivity evaluation.

  7minutes

• The Taiwan Short Form 36 Health Scale (SF-36)

  The Taiwan Short Form 36 Health Scale (SF-36) is a widely used health-related quality of life questionnaire and is also used by people with different cultural backgrounds. Research results show that SF36 has been proven to have good reliability and validity regardless of the diagnosis, age, and gender of the test subjects, and it can also sensitively detect changes before and after treatment without falling. Therefore, this study uses SF36 as the outcome measurement tool for this study.

  20minutes

Study Arms (2)

acupuncture

EXPERIMENTAL

Other: Real acupuncture; Other: Sham acupuncture

sham acupuncture

SHAM COMPARATOR

Other: Real acupuncture; Other: Sham acupuncture

Interventions

Real acupuncture OTHER

Real acupuncture twice a week for two weeks

acupuncture; sham acupuncture

Sham acupuncture OTHER

Sham acupuncture twice a week for two weeks

acupuncture; sham acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Exclusin Criteria
• Pregnant women
• Various acute and chronic infectious diseases, various skin ulcers, sores, burns, etc.
• The patient has injuries to the radial artery or wrist, or has steel nails, plates, or fractures.
• Various types of headaches related to anatomical structural lesions
• Headaches associated with taking or withdrawing from substances (drugs, food, or other chemicals)
• Headaches related to non-head infections and metabolic diseases
• People with painful cranial neuropathy, other facial pain and other headaches
• People with secondary headaches according to ICHD-3 beta

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Select A State, 333323, Taiwan

RECRUITING

MeSH Terms

Conditions

Migraine Disorders; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chien-Chung YANG

  Chang Gung Memorial Hospital

  STUDY DIRECTOR

Central Study Contacts

Chien-Chung YANG

CONTACT

03-3196200; r55161@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: May 3, 2024
• Study Start: January 31, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: May 7, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)