Table 2. Primary and Secondary Outcomes.
| Mean (SD) | Between-group change | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ICE | IPT | Usual care | ICE v usual care | IPT v usual care | |||||||||
| Baseline | Follow-upa | Difference | Baseline | Follow-upa | Difference | Baseline | Follow-upa | Difference | Effect estimate (95% CI)b | P value | Effect estimate (95% CI)b | P value | |
| Primary outcomes | |||||||||||||
| Change in ODI at 3 moc | 31.2 (16.9) | 15.4 (13.0) | −15.9 (16.2) | 29.3 (16.1) | 15.4 (13.7) | −13.9 (15.9) | 28.9 (17.4) | 19.5 (16.2) | −9.4 (18.3) | −5.8 (−7.7 to −3.9) | <.001d | −4.3 (−5.9 to −2.6) | <.001d |
| Total 12-mo spine-related health care spending, $ | 1448 (2756) | 2528 (2756) | 1587 (5774) | 0.93 (0.87 to 0.997) | .04d | 1.40 (1.35 to 1.45) | <.001d | ||||||
| Secondary outcomes | |||||||||||||
| Change in ODI at 12 mo | 31.2 (16.9) | 13.6 (13.0) | −17.7 (16.4) | 29.3 (16.1) | 13.0 (13.8) | −16.3 (16.1) | 28.9 (17.4) | 19.7 (17.8) | −9.2 (18.9) | −7.5 (−9.4 to −5.7) | <.001 | −6.7 (−8.4 to −5.0) | <.001 |
| EQ-5D-5L visual analog scale at 12 moe | 69.4 (18.7) | 78.4 (14.4) | 8.9 (7.7 to 10.2) | 68.7 (18.2) | 79.2 (14.2) | 10.5 (9.4 to 11.6) | 69.7 (19.0) | 72.9 (18.0) | 3.2 (1.8 to 4.5) | 4.7 (2.6 to 6.8) | <.001 | 6.0 (4.1 to 7.9) | <.001 |
| Lorig et al self-efficacy at 12 mof | |||||||||||||
| Functioning subscale | 82.9 (17.2) | 90.3 (12.6) | 7.4 (6.4 to 8.4) | 82.4 (18.7) | 88.7 (14.3) | 6.4 (5.4 to 7.3) | 82.5 (18.5) | 81.5 (20.3) | −1.0 (−2.3 to 0.3) | 6.8 (5.0 to 8.7) | <.001 | 6.7 (5.0 to 8.4) | <.001 |
| Other symptom subscale | 72.7 (20.8) | 83.4 (15.9) | 10.7 (9.4 to 12.1) | 71.5 (21.1) | 84.7 (16.1) | 13.2 (12.1 to 14.3) | 74.1 (21.5) | 77.6 (20.9) | 3.5 (2.1 to 5.0) | 4.0 (1.9 to 6.2) | <.001 | 6.3 (4.2 to 8.3) | <.001 |
Abbreviations: BMI, body mass index; EQ-5D-5L, EuroQol 5-dimensional 5-level; ICE, identify, coordinate, and enhance; IPT, individualized postural therapy; MCID, minimal clinically important difference; ODI, Oswestry Disability Index.
For the primary outcomes, follow-up is 3 months for ODI and 12 months for spine-related spending. For the secondary outcomes, follow-up is 12 months for all outcomes. For the post hoc outcome, follow-up is 12 months.
The effect estimate for ODI at 3 months, ODI at 12 months, EQ-5D-5L, and the Lorig et al self-efficacy scales are absolute differences. The effect estimate for spine-related health spending are risk ratios.
ODI scores capture pain-related disability based on patient self-report. ODI scores range from 0 (best) to 100 (worst). The MCID for ODI in patients with spine pain is 6 points.15
A 2-sided significance threshold of .025 was used to define statistical significance for the 2 primary outcomes.
EQ-5D-5L visual analog scale scores measure health-related quality of life. Scores range from 0 to 100, with 100 indicating the best score. The MCID for the EQ-5D-5L visual analog scale ranges from 5.3 to 10.5.21,22,23
The Lorig et al self-efficacy scale items ask individuals how certain they are that they can perform certain tasks or manage their symptoms. Scores range from 0 to 100, with 100 indicating the best score. The MCID for the Lorig et al self-efficacy scale has not been established.