Acupuncture as Migraine Prophylaxis in Reducing Frequency, Duration and Intensity of Migraine With Minimum Acupoint, Seen up to Eight Weeks From Baseline

NCT04509141 | Completed DMC

• 1 other identifier: medical acupuncture 2020
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Migraine is a primary headache attack, specific, paroxysmal, with or without aura, with subjective manifestations both before and after the attack, a chronic type of headache with symptoms of recurrence, attacks at productive age and can cause a decrease in work productivity up to 80%, so that it will affect the quality of life, economic life and education globally which leads to losses for migraine sufferers and institutions where migraine sufferers attend school, work and in the lives of sufferers' families.

Conditions

Migraine; Headache; Migraine Disorders

Keywords

migraine; acupuncture; visual analogue scale; headache

Outcome Measures

Primary Outcomes (6)

• frequency

  Manual acupuncture interventions can reduce the frequency of migraine attacks better than the preventive pharmacological valproic acid

  at week 4

• duration

  Manual acupuncture interventions can reduce the duration of migraine attacks better than the preventive pharmacological valproic acid

  at week 4

• intensity

  Manual acupuncture interventions can reduce the change from Baseline in pain scores on the Visual Analog Scale of migraine attacks better than the preventive pharmacological valproic acid

  at week 4

• frequency

  Manual acupuncture interventions can reduce the frequency of migraine attacks better than the preventive pharmacological valproic acid

  at week 8

• duration

  Manual acupuncture interventions can reduce the duration of migraine attacks better than the preventive pharmacological valproic acid

  at week 8

• intensity

  Manual acupuncture interventions can reduce the change from Baseline in pain scores on the Visual Analog Scale of migraine attacks better than the preventive pharmacological valproic acid

  at week 8

Study Arms (2)

acupuncture

ACTIVE COMPARATOR

acupuncture three times a week

Other: acupuncture

standard treatment for migraine by neurologist

ACTIVE COMPARATOR

standard treatment for migraine that was given by a neurologist

Other: acupuncture

Interventions

acupuncture OTHER

acupuncture points used were EXHN5 Taiyang, GB20 Fengchi, TE5 Waigun, GB41 Zulinqi

acupuncture; standard treatment for migraine by neurologist

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• subjects aged 19-50 years
• subjects with history of clinical diagnosis of migraine (interictal period)
• signed research approval forms, and were willing to take the study to completion.

You may not qualify if:

• subjects with pregnancy,
• lesions, wounds, infections and suffering from malignant diseases or tumor and thrombophlebitis in the area at the selected acupuncture point
• increasing liver function three times above normal values.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

University of Indonesia

Jakarta Pusat, DKI Jakarta, 10440, Indonesia

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

Acupuncture Therapy

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: the patient did not know that there were two groups divided in each participants, and the doctor who measures the outcome also did not know which person belongs to which group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A randomized controlled trial with control was conducted on 34 subjects with migraine who were randomly allocated into the manual group of acupuncture (n = 17), as well as the medicine group (n = 17). The assessment of frequency, duration and intensity of migraine attacks assessed at the time before treatment, at the fourth and eight week from baseline

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 11, 2020
• Study Start: July 5, 2019
• Primary Completion: August 7, 2019
• Study Completion: August 30, 2019
• Last Updated: August 11, 2020

Record last verified: 2020-08

Locations

ID (1)