Table 5.
Per patient pain relief and pain freedom at 15 minutes following the start of full, sub-perception or sham SPG stimulation during the experimental period. Not evaluable – patients who experienced a significant reduction in CH attack frequency and did not treat any CH attacks with the respective stimulation during the experimental period. Seventy-five CH attacks were excluded based on initial pain intensity of less than 2 on the CPS, and 13 CH attacks from nine patients were excluded because of missing 15-minute pain or medication usage response. A worst-case data imputation was performed for the 13 excluded attacks whereby full and sub-perception stimulation-treated attacks were counted as failures, and sham stimulation-treated attacks were counted as successes; the study conclusions were unaffected.
| Patient number | Full stimulation |
Sub-perception stimulation |
Sham stimulation |
||||||
|---|---|---|---|---|---|---|---|---|---|
| Total number treated | number (%) with relief (including freedom) | Number (%)with freedom | Total number treated | Number (%) with relief (including freedom) | Number (%) with freedom | Total number treated | Number (%) with relief (including freedom) | Number (%) with freedom | |
| 1 | 30 | 20 (67%) | 0 (0%) | 25 | 2 (8%) | 0 (0%) | 30 | 3 (10%) | 0 (0%) |
| 2 | 30 | 28 (93%) | 7 (23%) | 29 | 0 (0%) | 0 (0%) | 27 | 0 (0%) | 0 (0%) |
| 3 | 17 | 14 (82%) | 14 (82%) | 15 | 0 (0%) | 0 (0%) | 15 | 1 (7%) | 0 (0%) |
| 4 | 17 | 15 (88%) | 10 (59%) | 19 | 3 (16%) | 0 (0%) | 21 | 1 (5%) | 1 (5%) |
| 5 | 14 | 14 (100%) | 13 (93%) | 13 | 1 (8%) | 0 (0%) | 13 | 0 (0%) | 0 (0%) |
| 6 | 13 | 7 (54%) | 1 (8%) | 12 | 1 (8%) | 1 (8%) | 11 | 1 (9%) | 0 (0%) |
| 7 | 11 | 0 (0%) | 0 (0%) | 13 | 0 (0%) | 0 (0%) | 13 | 0 (0%) | 0 (0%) |
| 8 | 10 | 4 (40%) | 0 (0%) | 9 | 2 (22%) | 0 (0%) | 12 | 3 (25%) | 0 (0%) |
| 9 | 10 | 1 (10%) | 1 (10%) | 10 | 1 (10%) | 0 (0%) | 10 | 0 (0%) | 0 (0%) |
| 10 | 7 | 7 (100%) | 7 (100%) | 6 | 0 (0%) | 0 (0%) | 5 | 0 (0%) | 0 (0%) |
| 11 | 7 | 6 (86%) | 5 (71%) | 8 | 0 (0%) | 0 (0%) | 7 | 0 (0%) | 0 (0%) |
| 12 | 6 | 0 (0%) | 0 (0%) | 6 | 0 (0%) | 0 (0%) | 4 | 0 (0%) | 0 (0%) |
| 13 | 4 | 1 (25%) | 1 (25%) | 6 | 0 (0%) | 0 (0%) | 4 | 0 (0%) | 0 (0%) |
| 14 | 3 | 2 (67%) | 1 (33%) | 2 | 0 (0%) | 0 (0%) | 2 | 0 (0%) | 0 (0%) |
| 15 | 2 | 2 (100%) | 2 (100%) | 1 | 1 (100%) | 1 (100%) | 1 | 0 (0%) | 0 (0%) |
| 16 | 2 | 1 (50%) | 1 (50%) | 0 | Not evaluable | 1 | 1 (100%) | 0 (0%) | |
| 17 | 2 | 2 (100%) | 0 (0%) | 2 | 0 (0%) | 0 (0%) | 2 | 2 (100%) | 1 (50%) |
| 18 | 1 | 1 (100%) | 1 (100%) | 2 | 2 (100%) | 0 (0%) | 3 | 2 (67%) | 0 (0%) |
| 19 | 1 | 1 (100%) | 1 (100%) | 0 | Not evaluable | 1 | 1 (100%) | 1 (100%) | |
| 20 | 1 | 0 (0%) | 0 (0%) | 1 | 0 (0%) | 0 (0%) | 2 | 0 (0%) | 0 (0%) |
| 21 | 1 | 0 (0%) | 0 (0%) | 0 | Not evaluable | 0 | Not evaluable | ||
| 22 | 1 | 1 (100%) | 0 (0%) | 1 | 0 (0%) | 0 (0%) | 4 | 0 (0%) | 0 (0%) |
| 23 | 0 | Not evaluable | 1 | 0 (0%) | 0 (0%) | 0 | Not evaluable | ||
| 24 | 0 | Not evaluable | 1 | 0 (0%) | 0 (0%) | 3 | 0 (0%) | 0 (0%) | |
| 25 | 0 | Not evaluable | 0 | Not evaluable | 0 | Not evaluable | |||
| 26 | 0 | Not evaluable | 0 | Not evaluable | 0 | Not evaluable | |||
| 27 | 0 | Not evaluable | 1 | 1 (100%) | 1 (100%) | 1 | 0 (0%) | 0 (0%) | |
| 28 | 0 | Not evaluable | 1 | 0 (0%) | 0 (0%) | 0 | Not evaluable | ||
| TOTAL | 190 | 127 | 65 | 184 | 14 | 3 | 192 | 15 | 3 |
SPG: sphenopalatine ganglion; CH: cluster headache; CPS: categorical pain scale.