Table 2 Changes in severity of cluster headache, emotional impact and quality of life during the randomized phase
Active stimulation followed by sham stimulation (On–Off group) (n = 5) Median [range] | Sham stimulation followed by active stimulation (Off–On group) (n = 6) Median [range] | Difference between active and sham stimulation in the On–Off group Mean [95% CI] | Difference between active and sham stimulation in the Off–On group Mean [95% CI] | P value (treatment effect) | |||||
|---|---|---|---|---|---|---|---|---|---|
Baseline (week 8) | End of On period (week 12) | End of Off period (week 17) | Baseline (week 8) | End of Off period (week 12) | End of On period (week 17) | ||||
Attacks/week | 11 [2–42] | 18 [1–55] | 6 [1–49] | 16 [7–25] | 14.5 [0–28] | 9 [6–21] | 0.2 [−24.0; 23.6] | −2.7 [−25.7; 20.31] | 0.927 |
Sumatriptan (injection/week) | 7 [1–13] | 0 [0–18] | 1 [0–6] | 11.5 [1–29] | 12.5 [0–33] | 6.5 [0–25] | 2 [−9.0; 13] | −5.3 [−24.1; 13.5] | 0.349 |
Pain intensity | 5.5 [4–9] | 5 [3–8] | 5.5 [3–8] | 6 [2–9] | 5.7 [0–10] | 4.5 [2–9] | 0 [−1.4; 1.4] | 0.3 [−9.5; 10] | 0.357 |
PGIC | na | 2 [1–7] | 2 [1–6] | na | 2 [1–4] | 4 [1–7] | 0.8 [−20.1; 21.8] | 1.3 [−4.2; 6.8] | 0.853 |
HAD-A | 8.8 [5–10] | 8 [3–12] | 6 [4–14] | 11.5 [6–15] | 8 [5–10] | 9 [6–15] | 0.2 [−23.6.1; 24.0] | −2.6 [−25.5; 20.3] | 0.927 |
HAD-D | 8.5 [3–13] | 9 [4–13] | 1 [0–6] | 9.5 [1–13] | 4 [1–9] | 8 [1–16] | 1.3 [−22.4; 25.1] | 5.3 [−1.08; 11.7] | 0.154 |
SF 12-MS | 33.1 [28.1–52.1] | 34.5 [31.6–56.2] | 30.3 [17.8–59.9] | 36.4 [27.5–53.3] | 48.9 [24.9–54.2] | 36.7 [16–52.9] | 5.8 [−12.8; 24.4] | −8.7 [−27.3; 9.9] | 0.197 |
SF 12-PS | 29 [24.4–31.2] | 28.3 [27.2–29.0] | 33.8 [27.5–34.9] | 34.7 [32.2–46.5] | 37.9 [28.4–46.5] | 43.4 [28.1–51.5] | −3.9 [−13.1; 5.3] | 2.8 [−15.4; 21] | 0.197 |