Klinische Studien Radar

Change in standardized monthly headache days (SMHD) compared with baseline.

The primary outcome is the change in standardized monthly headache days (SMHD). SMHD are calculated by adjusting the actual number of headache days to a standard 28-day menstrual cycle using the following formula: SMHD = (actual headache days × 28) ÷ individual menstrual cycle length

At Week 12 post-treatment

change in standardized monthly headache days (SMHD) compared with baseline

At Weeks 4 and 8 post-treatment, and at Weeks 16, 20, and 24 during follow-up

The proportion of patients with cured MRM

Patients are defined as cured if they no longer met the diagnostic criteria for MRM.

At Week 12 post-treatment, and at weeks 16, 20, and 24 during follow-up

The responder rate

The responder rate is defined as a minimum of 50 % reduction in SMHD compared with baseline.

At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up

Change in standardized monthly headache severity score from baseline

Standardized monthly headache severity score = (Actual monthly severity score × 28) ÷ Individual menstrual cycle length.

At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up

Change in standardized monthly use of rescue medication from baseline

Rescue medication taken standardized monthly = (Actual doses × 28) ÷ Individual menstrual cycle length

At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up

Headache diary completion rate

Headache diary completion rate

At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up

Overall recruitment rate at End of recruitment phase

Recruitment rate = (Number of enrolled participants ÷ Total number of eligible patients) × 100%.

At end of the recruitment phase

Overall retention rate

Retention rate = (Number of participants who completed the study ÷ Total enrolled participants) × 100%.

At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up

Change in Hospital Anxiety and Depression Scale (HADS) score from baseline

The HADS is a validated self-report questionnaire used to assess symptoms of anxiety and depression over the past week. It consists of 14 items divided into two subscales: anxiety and depression, each containing 7 items. Each item is rated on a 4-point scale (0-3), yielding subscale scores ranging from 0 to 21. Higher scores reflect greater symptom severity.

At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up

Change in Headache Impact Test-6 (HIT-6) score from baseline

The HIT-6 is a validated, self-reported instrument used to assess the impact of headaches on health-related quality of life. It includes six items covering domains such as pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. Each item is scored on a 5-point Likert scale (6 = never, 8 = rarely, 10 = sometimes, 11 = very often, 13 = always). The total score ranges from 36 to 78, with higher scores indicating greater headache-related disability.

At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up

Change in Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) score from baseline

The MSQ v2.1 assesses migraine-related quality of life across three domains: Role Function-Restrictive , Role Function-Preventive , and Emotional Function. Each item is rated on a 6-point Likert scale from 1 ("All the time") to 6 ("None of the time"). Domain scores are calculated and transformed to a 0-100 scale, with higher scores indicating better quality of life.

At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up

Patient's Global Impression of Change (PGIC)

The PGIC scale will be used to assess participants' subjective perception of overall improvement. It is a 7-point scale with the following categories: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Lower scores indicate greater perceived improvement.

At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up

Participants' expectation for acupuncture

Participants will be asked the following question to assess their expectations regarding acupuncture for MRM: "What level of improvement do you expect from acupuncture for your MRM?" Response options will include: "no improvement," "slight improvement," "moderate improvement," "marked improvement," and "unclear." The association between participants' expectations and the primary outcome will be examined using statistical analysis.

At baseline