Enhancing chronic migraine preventive therapy: laser acupuncture as an add-on treatment for patients with unsatisfactory pharmacological effect

Phase 3

Completed

• Conditions: Chronic migraine; Nervous System Diseases

• Registration Number: ISRCTN11208146
• Lead Sponsor: Taichung Veterans General Hospital

Brief Summary

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39198866/ (added 02/09/2024)

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-12-01
• Study Start: 2024-01-19
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Aged >20 years old and had CM managed pharmacologically, including preventive and/or acute migraine medications, and in addition, those who had refused preventive agents despite the recommendation of the neurologist
2. Unsatisfactory effect of current pharmacological treatments, defined by self-reporting
3. A minimum of a one-year history of migraine with or without aura

Exclusion Criteria

1. Received another LA therapy or traditional acupuncture at baseline
2. Migraine onset after the age of 50
3. Cognitive or psychological impairment interfering with the participant’s ability to receive LA protocol and describe symptoms
4. Patients with missing data at baseline or during the follow-up period

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in the number of monthly migraine days from baseline measured using a headache diary at each of the three follow-up time points (4th, 8th and 12th weeks) after randomization

Secondary Outcome Measures

Name	Time	Method
The following secondary outcome measures were measured at each of the three follow-up time points (4th, 8th and 12th weeks):<br>1. The proportion of patients with a = 30% reduction in migraine days measured using a headache diary<br>2. Changes in the following parameters: (1) headache duration measured using a headache diary; (2) headache severity measured using a Numerical Rating Scale (NRS) and (3) headache-related disability measured using the Migraine Disability Assessment Score (MIDAS)<br>3. Acute headache medications usage days per month measured using a headache diary