Table 3 Headache pain outcomes following e-TNS session: Verum vs. Sham.

From: Phase 3 randomized, double-blind, sham-controlled Trial of e-TNS for the Acute treatment of Migraine (TEAM)

Variable, # (%)

ITT analysis

Per protocol analysis

Verum (n = 259)

Sham (n = 279)

Total (N = 538)

X2-statistic

ES

P

Verum (n = 207)

Sham (n = 231)

Total (N = 438)

X2-statistic

ES

P

Pain freedom at 2 h

66 (25.5)

51 (18.3)

117 (21.7)

4.10

0.18

0.043

57 (27.5)

44 (19.0)

101 (23.1)

4.434

0.20

0.035

Absence of MBS at 2 h

146 (56.4)

118 (42.3)

264 (49.1)

10.65

0.28

0.001

119 (57.5)

100 (43.3)

219 (50.0)

8.803

0.28

0.003

Pain relief at 2 h

180 (69.5)

154 (55.2)

334 (62.1)

11.67

0.30

0.001

151 (72.9)

132 (57.1)

283 (64.6)

11.925

0.35

0.001

Absence of all MAS at 2 h

110 (42.5)

95 (34.1)

205 (38.1)

4.04

0.18

0.044

95 (45.9)

79 (34.2)

174 (39.7)

6.236

0.24

0.013

Rescue meds at 2–24 h

82 (31.7)

105 (37.6)

187 (34.8)

2.11

− 0.12

0.146

67 (32.4)

90 (39.0)

157 (35.8)

2.064

− 0.14

0.151

Pain freedom at 24 h

59 (22.8)

44 (15.8)

103 (19.1)

4.26

0.18

0.039

50 (24.2)

38 (16.5)

88 (20.1)

4.036

0.20

0.045

Pain relief at 24 h

119 (45.9)

96 (34.4)

215 (40.0)

7.45

0.24

0.006

94 (45.4)

84 (36.4)

178 (40.6)

3.704

0.18

0.054

  1. MBS most bothersome symptom, MAS migraine-associated symptoms, ES effect size.
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