Table 2 Primary and secondary outcome measures. Values are medians (25th to 75th centiles) unless stated otherwise

Active-placebo group
 Placebo-active group
 P value (active v placebo){dagger}
Measure
 Period 1(A)
 Period 2(P)
 Period 1(P)
 Period 2(A)
 Difference (95% CI)*
Reduction in median spontaneous pain from baseline (numerical rating scale)
–1.0 (–1.9 to –0.1)
0 (–2.0 to 0)
0 (0 to 0.9)
–1.5 (–2.8 to –0.3)
–0.6 (–1.8 to 0)
0.02
Pain relief (numerical rating scale)
3.0 (0.0 to 7.5)
0.5 (0 to 5.3)
0 (0 to 0)
4.0 (1.3 to 6.8)
2.5 (0.5 to 4.5)
0.035
50% pain relief (No (%))
5 (42)
3 (25)
1 (8)
6 (50)
—
0.08
Radiating pain, diary (numerical rating scale)
1.8 (0.0 to 6.0)
4.8 (0.0 to 5.8)
1.5 (0.0 to 4.0)
0.8 (0.0 to 2.0)
–0.6 (–1.3 to 0)
0.039
Treatment preference (No (%))
5 (42)
5 (42)
1 (8)
9 (75)
—
0.14
Escape medication (daily No of paracetamol)
0 (0 to 3.5)
0 (0 to 3.5)
0 (0 to 0)
0 (0 to 0)
0
0.66
Expanded disability status scale
6.0 (4.5 to 6.4)
6.0 (4.6 to 6.4)
5.8 (3.6 to 6.0)
5.5 (4.3 to 6.0)
0
1.00
Quantitative sensory testing{ddagger}





Cold detection threshold
23.7 (16.4 to 26.9)
24.2 (20.8 to 26.1)
24.3 (22.2 to 27.0)
26.5 (24.0 to 28.3)
0.5 (–0.6 to 1.8)
0.44
Warm detection threshold
41.5 (35.1 to 45.9)
38.8 (34.6 to 44.2)
40.1 (34.4 to 47.0)
43.5 (33.5 to 46.4)
0.1 (–0.1 to 1.8)
0.83
Cold pain threshold
9.6 (0.2 to 22.2)
12.8 (1.3 to 22.5)
12.9 (5.4 to 22.8)
20.4 (0.0 to 23.2)
0.0 (–1.1 to 2.1)
1.00
Heat pain threshold
45.3 (42.6 to 46.5)
43.2 (40.7 to 47.9)
46.6 (43.3 to 48.5)
46.4 (43.1 to 49.4)
0.3 (–0.4 to 1.3)
0.46
Cold sensibility index
0.49 (0.36 to 0.61)
0.51 (0.26 to 0.70)
0.61 (0.04 to 0.76)
0.75 (0.14 to 0.80)
0.1 (–0.0 to 0.2)
0.34
Warm sensibility index
0.22 (0.08 to 0.63)
0.20 (0.10 to 0.59)
0.31 (0.07 to 0.70)
0.29 (0.16 to 0.57)
0.0 (–0.1 to 0.1)
0.52
Tactile detection threshold (g)
1.8 (0.6 to 3.6)
1.5 (0.6 to 3.6)
1.2 (1.2 to 8.5)
1.2 (0.7 to 3.6)
0.0 (–1.1 to 0.7)
0.95
Tactile pain detection threshold (g)
13.4 (6.2 to 354.0)
42.2 (4.9 to 281.8)
28.8 (11.7 to 75.9)
75.9 (5.5 to 125.9)
0.0 (–4.1 to 23.9)
0.90
Pressure pain threshold (kPa)
304 (157 to 421)
216 (170 to 437)
263 (213 to 403)
343 (245 to 462)
42.8 (1.0 to 78.5)
0.036
Vibration threshold (µm)
2.4 (1.7 to 75.2)
3.2 (1.2 to 19.3)
2.5 (1.4 to 34.3)
1.8 (1.1 to 33.3)
0.0 (–0.6 to 2.2)
0.88
Temporal summation (No (%))
5 (42)
7 (58)
5/11 (46)
4/11 (36)
—
0.43
Mechanical allodynia (No (%))§
 2 (17)
1 (8)
0 (0)
0 (0)
—

Cold allodynia (No (%))
5 (42)
3 (25)
5/11 (46)
4/11 (36)
—
1.00
SF-36{ddagger}





Physical functioning
40.0 (20.0 to 58.9)
35.0 (16.3 to 45.0)
30.0 (20.0 to 60.0)
40.0 (25.0 to 55.0)
5.0 (0 to 7.5)
0.06
Role physical
25.0 (0 to 50.0)
25.0 (0 to 93.8)
25.0 (25.0 to 100)
50.0 (25.0 to 100.0)
0 (–25.0 to 12.5)
0.73
Bodily pain
41.0 (22.0 to 62.0)
26.5 (21.3 to 48.5)
42.0 (31.0 to 51.0)
61.0 (42.0 to 74.0)
9.8 (0 to 21.5)
0.037
General health
43.5 (35.0 to 73.3)
46.0 (25.0 to 74.5)
35.0 (27.0 to 62.0)
32.0 (25.0 to 57.0)
0 (–6.0 to 5.0)
0.95
Vitality
42.5 (18.8 to 57.5)
27.5 (16.3 to 58.8)
40.0 (25.0 to 55.0)
35.0 (30.0 to 45.0)
2.5 (–5.0 to 10.0)
0.52
Social functioning
100.0 (62.5 to 100.0)
100.0 (53.1 to 100.0)
75.0 (50.0 to 87.5)
87.5 (75.0 to 100.0)
6.3 (0 to 12.5)
0.17
Mental health
86.0 (72.0 to 95.0)
84.0 (60.0 to 100.0)
72.0 (52.0 to 84.0)
84.0 (68.0 to 88.0)
8.0 (0 to 12.0)
0.023
Role emotional
100.0 (75.0 to 100.0)
100.0 (75.0 to 100.0)
100.0 (66.7 to 100.0)
100.0 (66.7 to 100.0)
0 (–33.0 to 0)
0.46

A=active treatment; P=placebo.

* Hodges-Lehmann estimator.

{dagger} No corrections for multiple comparisons.

{ddagger} Based on 23 patients (missing data for one patient in placebo-active group).

§ Impossible to do planned test.