Acupuncture for Frequent Migraine: A Randomized, Patient/Assessor Blinded, Controlled Trial with One-Year Follow-Up

Table 3

Outcome measures used in the trial.

Outcome measures	Instruments	Baseline (4 weeks)	Treatment (20 weeks)	Follow-up (phase 1^* and phase II^#)
Primary outcomes
Frequency of migraine	Headache diary	Daily for 4 weeks	Daily for 20 weeks	Phase I: daily for 12 weeks and this is between 21st week and 32nd week after randomization.; Phase II: daily for 4 weeks and this is between 68th week and 72nd week after randomization.
Duration of migraine	24-hour Visual Analogue Scale (VAS)
Intensity of migraine	0–10 VAS and a Six-Point Likert Scale
Response rate	Percentage of patients with more than 50% reduction in the number of days with migraine attack per four weeks	Calculated based on the frequency data and reported on weekly basis
Secondary outcomes
Relief medication usage	Pill count and the Medication Quantification Scale	Daily for 4 weeks	Daily for 20 weeks	Phase I: daily for 12 weeks and this is between 21st week and 32nd week after randomization.; Phase II: daily for 4 weeks and this is between 68th week and 72nd week after randomization.
Severity and quality of migraine	McGill pain questionnaire [19]	At the last week of baseline	At the 4th, 8th, 12th, 16th, and 20th week after randomization	Phase I: at the 24th, 28th, and 32nd week after randomization.; Phase II: at the 72nd week after randomization.
Quality of life	Migraine Specific Quality of Life questionnaire [20]
Pressure pain threshold	A handheld pressure algometer	Before the 1st treatment	After the last treatment

^*Phase I follow-up period: 3 months from the end of the treatment.
^#Phase II follow-up period: one year from the end of the treatment.