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. 2018 Apr 16;75(7):808–817. doi: 10.1001/jamaneurol.2018.0492

Table 2. Primary and Secondary Outcomesa.

Characteristic Experimental Treatment Control Treatment Group Difference, Mean (95% CI) Effect Size Main Effect of Time Interaction Effect Bonferroni Post Hoc Tests
Estimated Marginal Mean (SE) Change Relative to Baseline, % Estimated Marginal Mean (SE) Change Relative to Baseline, % F Score P Value F Score P Value Time Group
Pain as a Primary Outcome Measure
PPT prim, kgfb
Baseline 4.558 (0.339) NA 4.429 (0.330) NA 0.129 (−1.064 to 0.806) NA 37.483 .23 4.866 .03 P < .001c;
P = .009d
P = .06c,d
At 3 mo 6.148 (0.353) 25.86 5.177 (0.363) 14.45 0.971 (−0.028 to 1.970) .46
PPT hand, kgf
Baseline 3.598 (0.250) NA 3.604 (0.243) NA −0.006 (−0.695 to 0.683) NA 20.977 <.001 1.738 .19 P < .001c,d NA
At 3 mo 4.413 (0.260) 18.47 4.049 (0.267) 11.00 0.364 (−0.372 to 1.100) .26
PPT leg, kgf
Baseline 5.328 (0.357) NA 5.077 (0.348) NA 0.250 (−0.736 to 1.237) NA 21.168 <.001 2.583 .11 P < .001c,d NA
At 3 mo 6.544 (0.372) 18.59 5.654 (0.382) 10.21 0.889 (−0.164 to 1.942) .31
CPM primb
Baseline 1.075 (0.196) NA 1.054 (0.193) NA 0.021 (−0.522 to 0.564) NA 3.259 .07 2.480 .12 NA NA
At 3 mo 1.511 (0.211) 28.86 1.190 (0.224) 11.43 0.321 (−0.287 to 0.928) .16
CPM leg
Baseline 1.058 (0.205) NA 0.904 (0.199) NA 0.154 (−0.719 to 0.411) NA 1.505 .22 0.019 .89 NA NA
At 3 mo 1.259 (0.221) 15.97 1.156 (0.234) 21.80 0.103 (−0.532 to 0.739) .09
NRS score (of 10)
Baseline 5.153 (0.247) NA 4.983 (0.245) NA 0.169 (−0.519 to 0.858) NA 34.831 <.001 2.172 .10 Baseline >3, 6, 12 mo
(P < .001c,d)
NA
At 3 mo 2.462 (0.302) −52.22 3.332 (0.311) −33.13 −0.871 (−1.731 to −0.010) .52
At 6 mo 2.948 (0.326) −42.79 3.808 (0.341) −23.58 −0.859 (−1.796 to 0.078) .43
At 12 mo 2.655 (0.308) −48.48 3.369 (0.315) −32.39 −0.714 (−1.588 to 0.160) .44
CSI score (of 100)
Baseline 40.017 (1.473) NA 39.883 (1.473) NA 0.133 (−3.992 to 4.259) NA 39.254 <.001 7.537 .003 Baseline >3, 6, 12 mo
(P < .001c; P ≤ .003d)
6 mo (P = .02);
12 mo (P = .01)
At 3 mo 30.668 (1.690) −23.36 35.235 (1.714) −11.65 −4.567 (−9.334 to 0.201) .68
At 6 mo 28.538 (1.732) −28.69 34.222 (1.769) −14.19 −5.684 (−10.589 to −0.780) .73
At 12 mo 29.358 (1.671) −26.64 35.410 (1.703) −11.22 −6.053 (−10.781 to −1.324) .74
Function as a Primary Outcome Measure
PDI score (of 70)
Baseline 21.800 (1.811) NA 21.583 (1.811) NA 0.217 (−4.856 to 5.289) 34.979 <.001 2.999 .03 Baseline >3, 6, 12 mo
(P < .001c,d)
3 mo (P = .04);
6 mo (P = .01);
12 mo (P = .01)
At 3 mo 9.384 (1.720) −56.95 14.497 (1.762) −32.83 −5.113 (−9.994 to −0.232) .49
At 6 mo 7.884 (1.688) −63.83 14.235 (1.720) −34.05 −6.351 (−11.153 to −1.550) .56
At 12 mo 8.138 (1.605) −62.67 13.916 (1.649) −35.52 −5.779 (−10.340 to −1.217) .48
SF36 mental health component score (of 400)
Baseline 279.344 (9.121) NA 280.242 (9.121) NA −0.897 (−26.440 to 24.646) NA 7.019 <.001 3.213 .03 Baseline <3, 6, 12 mo
(P < .001c)
6 mo (P = .01)
At 3 mo 316.700 (9.427) 11.80 293.030 (9.717) 4.36 23.670 (−3.168 to 50.509) .42
At 6 mo 320.942 (10.002) 12.96 284.446 (10.326 1.24 36.496 (7.998 to 64.995) .62
At 12 mo 316.204 (12.192) 11.66 291.520 (12.582) 3.87 24.685 (−10.092 to 59.461) .27
SF36 physical health component score (of 400)
Baseline 235.750 (9.540) NA 225.625 (9.540) NA 10.125 (−16.593 to 36.843) NA 45.269 <.001 4.983 .003 Baseline <3, 6, 12 mo
(P < .001c,d)
3 mo (P = .009);
6 mo (P < .001);
12 mo (P = .03)
At 3 mo 304.915 (10.036) 22.68 266.652 (10.366) 15.39 39.263 (9.644 to 66.882) .46
At 6 mo 320.130 (10.277) 26.36 267.123 (10.552) 15.54 53.007 (23.805 to 82.209) .78
At 12 mo 314.764 (10.475) 25.30 282.557 (10.769) 20.15 32.208 (2.402 to 62.014) .30
Secondary Outcome Measures
TSK score (of 68)
Baseline 34.367 (0.900) NA 36.717 (0.900) NA −2.350 (−4.870 to 0.170) NA 53.394 <.001 13.165 <.001 Baseline >3, 6, 12 mo
(P < .001c;
P ≤ .007d)
3 mo (P < .001);
6 mo (P < .001);
12 mo (P < .001)
At 3 mo 24.349 (0.838) −29.15 33.029 (0.714) −10.04 −8.680 (−11.067 to −6.294) 1.11
At 6 mo 23.904 (0.871) −30.44 33.714 (0.904) −8.18 −9.810 (−12.301 to −7.320) 1.25
At 12 mo 24.020 (0.785) −30.11 32.882 (0.808) −10.44 −8.862 (−11.097 to −6.628) 1.14
PVAQ score (of 80)
Baseline 36.900 (1.587) NA 35.767 (1.587) NA 1.133 (−3.312 to 5.579) NA 20.764 <.001 6.374 .001 Baseline >3, 6, 12 mo
(P < .001c)
3 mo (P = .001);
6 mo (P = .005);
12 mo (P = .01)
At 3 mo 24.878 (1.648) −32.58 33.142 (1.699) −7.34 −8.265 (−12.959 to −3.571) .88
At 6 mo 24.740 (1.762) −32.95 32.008 (1.823) −10.51 −7.269 (−12.294 to −2.243) .79
At 12 mo 25.346 (1.673) −31.31 31.662 (1.673) −11.48 −6.316 (−11.070 to −1.561) .73
PCS total score (of 52)
Baseline 16.533 (1.310) NA 16.850 (1.310) NA −0.317 (−3.986 to 3.353) NA 41.653 <.001 1.609 .19 Baseline >3, 6, 12 mo
(P < .001c,d);
3 mo >6, 12 mo
(P = .001c,d)
NA
At 3 mo 8.845 (1.201) −46.50 12.496 (1.233) −25.84 −3.652 (−7.065 to −0.239) .44
At 6 mo 6.576 (1.145) −60.23 9.550 (1.183) −43.32 −2.974 (−6.239 to 0.291) .36
At 12 mo 6.051 (1.135) −63.40 9.488 (1.171) −43.69 −3.437 (−6.673 to −0.201) .35

Abbreviations: CPM, conditioned pain modulation; CSI, Central Sensitization Inventory; kgf, kilogram force; NA, not applicable; NRS, Numeric Rating Scale; PCS, Pain Catastrophizing Scale, PDI, Pain Disability Index; PPT, pressure pain threshold; prim, primary (pain) test site; PVAQ, Pain Vigilance and Awareness Questionnaire; SF36, 36-Item Short Form Health Survey; TSK, Tampa Scale for Kinesiophobia.

a

All analyses were performed using linear mixed models. The Cohen d is interpreted as very large (>1.3), large (0.80-1.29), medium (0.50-0.79), small (0.20-0.49), and negligible (<0.20).

b

Values of people with neck pain and low back pain measures at the primary test site were analyzed together, using PPT location as confounding factor within the linear mixed models analysis.

c

Results of Bonferroni post hoc tests in the experimental group.

d

Results of Bonferroni post hoc tests in the control group.