Table 2.
Pain-Specific Outcomes in the 274 Participants Enrolled in the INCPAD Trial for Pain
| Clinical Outcome | Intervention (137)a | Usual Care (137)a | Time-Specific Between-Group Difference or Relative Risk (95% CI) | Overall P value by MMRMb |
|---|---|---|---|---|
| Primary pain outcome (n = assessed cases) | ||||
| BPI pain severity, mean (SD) (range, 0–10) | <.0001 | |||
| Baseline (n = 274) | 5.23 (1.85) | 5.20 (1.78) | 0.03 (−0.40 to 0.46) | |
| 3-mo follow-up (n = 230) | 3.30 (2.45) | 4.52 (2.33) | −1.22 (−1.85 to −0.60) | |
| 6-mo follow-up (n = 206) | 3.55 (2.36) | 4.38 (2.21) | −0.83 (−1.46 to −0.20) | |
| 12-mo follow-up (n = 180) | 3.62 (2.42) | 4.33 (2.21) | −0.70 (−1.39 to −0.02) | |
| BPI pain severity responder, N (%)c | <.0001 | |||
| 3-mo follow-up (n = 230) | 67 (57.3) | 34 (30.1) | 1.90 (1.38 to 2.63) | |
| 6-mo follow-up (n = 206) | 51 (49.5) | 27 (26.2) | 1.89 (1.29 to 2.76) | |
| 12-mo follow-up (n = 180) | 46 (50.6) | 31 (34.8) | 1.45 (1.02 to 2.06) | |
| Secondary pain outcomes (n = assessed cases) | ||||
| BPI pain interference, mean (SD) (range, 0–10) | <.0001 | |||
| Baseline (n = 274) | 5.35 (2.62) | 5.96 (2.48) | −0.61 (−1.22 to 0.00) | |
| 12-mo follow-up (n = 168) | 3.86 (2.45) | 5.08 (2.88) | −1.22 (−2.04 to −0.40) | |
| SF-36 bodily pain scale, mean (SD) (range, 0–100) | .004 | |||
| Baseline (n = 272) | 32.8 (18.1) | 30.7 (17.5) | 2.1 (−2.1 to 6.4) | |
| 12-mo follow-up (n = 179) | 48.4 (24.7) | 39.0 (22.6) | 9.4 (2.4 to 16.4) | |
a
The number of subjects with pain who were assessed for pain outcomes was 230 (117 intervention and 113 controls) at 3 months, 206 (103 intervention and 103 controls) at 6 months, and 180 (91 intervention and 89 controls) at 12 months.
b
Mixed effects model repeated measures (MMRM) analysis was used to compare group differences over 12 months, adjusting for time effect and for baseline value of outcome variable. Assessments were conducted at baseline, 1, 3, 6 and 12 months for BPI severity and interference and at baseline, 3 and 12 months for SF-36 bodily pain.
c
Defined as 30% or greater decrease in BPI severity from baseline