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

INTERVENTION: This study is a single‐blind randomized controlled trial, conducted from January 2022 to November 2023, aimed to investigate the efficacy and safety of laser acupuncture (LA) as an add‐on preventive therapy for chronic migraine (CM) in patients with unsatisfactory pharmacological effects. The intervention comprises non‐invasive laser stimulation energy of 4.5 J for 30 seconds at each of the following acupoints: bilateral Cuanzhu (BL2), Fengchi (GB20), Taiyang (EX‐HN5), Shuaigu (GB8), Hegu (LI4), Taichong (LR3) and midline Yintang (EX‐HN3). Participants were randomized by computer software (Excel 2016 for Windows). Study arms: Experimental: laser acupuncture CM patients with unsatisfactory pharmacological effects receive laser acupuncture for 8 sessions that spanned 4 weeks. Device intervention: Laser stimulation energy of 4.5 J for 30 seconds at each of the following acupoints: bilateral Cuanzhu (BL2), Fengchi (GB20), Taiyang (EX‐HN5), Shuaigu (GB8), Hegu (LI4), Taichong (LR3) and midline Yintang (EX‐HN3) Sham Comparator: Sham treatment Sham treatment had no laser output. Device intervention: Sham treatment with no laser output, stimulate the same acupoints as the laser acupuncture group as follows: 30 seconds at bilateral Cuanzhu (BL2), Fengchi (GB20), Taiyang (EX‐HN5), Shuaigu (GB8), Hegu (LI4), Taichong (LR3) and midline Yintang (EX‐HN3) Follow‐up activity. After completing the study and unblinding, we will provide authentic laser acupuncture to individuals randomized to the Sham group. Intervention provider The laser application procedures will be performed by the same experienced physician who was a well‐trained and licensed Chinese medicine practitioner in Taiwan. The execution process adhered to the regulations of the Taiwan Ministry of Health and Welfare. CONDITION: Chronic migraine ; Nervous System Diseases PRIMARY OUTCOME: 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: The following secondary outcome measures were measured at each of the three follow‐up time points (4th, 8th and 12th weeks):; 1. The proportion of patients with a = 30% reduction in migraine days measured using a headache diary; 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); 3. Acute headache medications usage days per month measured using a headache diary 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