Table 2. Primary and Secondary Clinical Outcomes.
| Between-group differencesa | Mean (SD) | PRT vs placebo, g (SE)b | P value | PRT vs usual care, g (SE)b | P value | ||
|---|---|---|---|---|---|---|---|
| PRT | Placebo | Usual care | |||||
| Primary outcome | |||||||
| Pain intensity (0-10) | |||||||
| Baseline | 4.22 (1.21) | 4.16 (1.33) | 3.91 (1.24) | NA | NA | NA | NA |
| Posttreatment | 1.18 (1.24) | 2.84 (1.64) | 3.13 (1.45) | −1.14 (0.24) | <.001 | −1.75 (0.24) | <.001 |
| At 1 mo | 1.26 (1.77) | 2.91 (1.97) | 3.07 (1.63) | −0.83 (0.27) | <.001 | −1.24 (0.29) | <.001 |
| At 2 mo | 1.59 (1.92) | 3.06 (1.89) | 3.00 (1.86) | −0.84 (0.28) | .001 | −1.03 (0.28) | <.001 |
| At 3 mo | 1.54 (1.68) | 3.21 (2.02) | 3.27 (1.95) | −0.93 (0.23) | <.001 | −1.35 (0.25) | <.001 |
| At 6 mo | 1.39 (1.48) | 2.68 (2.08) | 2.95 (1.93) | −0.74 (0.23) | .001 | −1.14 (0.26) | <.001 |
| At 12 mo | 1.51 (1.59) | 2.79 (1.78) | 3.00 (1.77) | −0.70 (0.21) | .001 | −1.05 (0.24) | <.001 |
| Secondary outcome | |||||||
| Oswestry Disability Index (0-100) | |||||||
| Baseline | 23.70 (10.70) | 23.06 (10.14) | 23.26 (9.67) | NA | NA | NA | NA |
| Posttreatment | 10.14 (10.63) | 19.00 (11.07) | 20.68 (10.68) | −1.30 (0.28) | <.001 | −1.70 (0.26) | <.001 |
| At 1 mo | 10.58 (14.26) | 18.68 (11.95) | 20.30 (9.04) | −1.04 (0.25) | <.001 | −1.61 (0.27) | <.001 |
| At 2 mo | 9.57 (12.86) | 19.43 (11.84) | 21.37 (11.07) | −1.30 (0.29) | <.001 | −1.55 (0.23) | <.001 |
| At 3 mo | 9.68 (13.39) | 21.42 (14.32) | 23.57 (13.36) | −1.26 (0.28) | <.001 | −1.61 (0.25) | <.001 |
| At 6 mo | 9.80 (11.94) | 18.50 (13.43) | 20.84 (11.57) | −0.96 (0.26) | <.001 | −1.3 (0.28) | <.001 |
| At 12 mo | 11.16 (13.13) | 18.52 (12.60) | 18.78 (12.59) | −0.23 | <.001 | −0.83 (0.24) | <.001 |
| PROMIS depression, raw score (8-32) | |||||||
| Baseline | 14.66 (4.39) | 13.17 (4.67) | 12.85 (4.74) | NA | NA | NA | NA |
| Posttreatment | 12.23 (4.94) | 11.75 (4.05) | 11.81 (4.45) | −0.35 (0.24) | .099 | −0.56 (0.24) | .009 |
| At 1 mo | 12.87 (5.23) | 10.64 (3.57) | 11.57 (4.61) | 0.13 (0.23) | .555 | −0.54 (0.25) | .019 |
| At 2 mo | 12.51 (4.88) | 11.11 (4.95) | 11.76 (5.17) | −0.08 (0.24) | .723 | −0.51 (0.24) | .028 |
| At 3 mo | 11.47 (4.64) | 12.45 (6.09) | 12.30 (4.51) | −0.57 (0.24) | .015 | −0.90 (0.22) | <.001 |
| At 6 mo | 12.90 (5.28) | 10.97 (4.00) | 11.84 (4.65) | −0.09 (0.24) | .701 | −0.47 (0.23) | 0.40 |
| At 12 mo | 12.53 (5.12) | 11.95 (5.86) | 12.75 (4.50) | −0.20 (0.23) | .360 | −0.62 (0.24) | .007 |
| PROMIS anger, raw score (5-25) | |||||||
| Baseline | 12.46 (3.73) | 10.97 (3.18) | 11.17 (3.18) | NA | NA | NA | NA |
| Posttreatment | 9.52 (3.91) | 9.89 (3.81) | 10.45 (3.86) | −0.62 (0.21) | .004 | −0.78 (0.21) | <.001 |
| At 1 mo | 9.50 (4.40) | 8.84 (3.27) | 10.55 (3.19) | −0.23 (0.25) | .291 | −0.91 (0.25) | <.001 |
| At 2 mo | 10.70 (4.68) | 9.37 (3.30) | 10.00 (3.92) | −0.11 (0.23) | .652 | −0.28 (0.25) | .231 |
| At 3 mo | 9.31 (4.06) | 9.87 (4.78) | 10.49 (3.52) | −0.52 (0.21) | .027 | −0.92 (0.25) | <.001 |
| At 6 mo | 9.83 (4.49) | 9.31 (2.96) | 10.51 (3.44) | −0.38 (0.25) | .099 | −0.90 (0.23) | <.001 |
| At 12 mo | 10.49 (4.15) | 9.64 (3.55) | 10.89 (3.38) | −0.16 (0.21) | .454 | −0.61 (0.22) | .008 |
| PROMIS anxiety, raw scores (8-40) | |||||||
| Baseline | 16.37 (5.88) | 15.52 (5.83) | 15.11 (6.40) | NA | NA | NA | NA |
| Posttreatment | 15.02 (6.16) | 13.89 (5.78) | 14.11 (6.99) | 0 (0.22) | 1.00 | −0.21 (0.21) | .318 |
| At 1 mo | 14.58 (6.45) | 12.25 (4.81) | 13.75 (6.78) | 0.36 (0.20) | .109 | −0.29 (0.21) | .203 |
| At 2 mo | 14.14 (7.07) | 13.23 (6.74) | 13.58 (6.75) | 0.02 (0.24) | .923 | −0.22 (0.25) | .348 |
| At 3 mo | 13.75 (6.45) | 14.50 (7.42) | 14.08 (6.42) | −0.34 (0.23) | .147 | −0.62 (0.21) | .009 |
| At 6 mo | 14.88 (7.12) | 13.00 (5.14) | 14.59 (6.90) | 0.03 (0.24) | .907 | −0.50 (0.24) | .028 |
| At 12 mo | 14.09 (6.79) | 14.07 (7.51) | 14.81 (6.94) | −0.20 (0.22) | .362 | −0.56 (0.23) | .014 |
| PROMIS sleep, raw score (8-40) | |||||||
| Baseline | 22.21 (6.54) | 22.65 (6.38) | 22.63 (6.26) | NA | NA | NA | NA |
| Posttreatment | 17.73 (6.75) | 20.50 (6.17) | 20.89 (6.02) | −0.41 (0.23) | .056 | −0.63 (0.22) | .003 |
| At 1 mo | 17.18 (6.38) | 21.02 (6.34) | 21.62 (6.45) | −0.46 (0.25) | .039 | −0.89 (0.27) | <.001 |
| At 2 mo | 17.08 (6.71) | 19.71 (6.72) | 21.74 (7.19) | −0.38 (0.24) | .112 | −0.84 (0.27) | <.001 |
| At 3 mo | 16.67 (6.67) | 20.16 (7.05) | 21.73 (6.26) | −0.44 (0.24) | .061 | −1.08 (0.24) | <.001 |
| At 6 mo | 17.85 (7.24) | 19.42 (6.22) | 21.38 (6.03) | −0.29 (0.23) | .198 | −0.85 (0.23) | <.001 |
| At 12 mo | 18.11 (7.36) | 19.95 (5.79) | 21.19 (6.73) | −0.23 (0.22) | .272 | −0.60 (0.25) | .009 |
Abbreviations: NA, not applicable; PROMIS, Patient-Reported Outcome Measurement Information System; PRT, pain reprocessing therapy.
a
Effect sizes show the group difference in change from baseline (group × time interaction), including all available data at the follow-up time point and corresponding baseline data for effect size computation.
b
Hedges g and SE estimated with bootstrapping procedure.