Patient Outcomes at 6-Month Follow-up
| Outcome | Phase 1 (n = 368) | Phase 3 (n = 554) | Effect Estimatea (95% CI) | P Valuea |
|---|---|---|---|---|
| Function and pain | ||||
| Disability: change in RMDQ score | 2.2 (6.0) | 2.7 (5.5) | 0.71 (0.06 to 1.36)b | .03 |
| Achieved MCIDc, No. (%) | 154 (42) | 261 (47) | 1.24 (0.92 to 1.67)d | .15 |
| Pain intensity: change in NRS rating | 1.7 (2.8) | 1.9 (3.2) | 0.29 (−0.05 to 0.63)b | .09 |
| Physical function: change in SF-12 PCS score | −3.7 (11.5) | −3.9 (16.3) | −0.78 (−2.47 to 0.92)b | .35 |
| Psychosocial outcomes | ||||
| Catastrophizing: change in PCS-CAT score | 1.7 (8.3) | 1.8 (10.3) | 0.28 (−1.13 to 1.68)b | .67 |
| Fear avoidance: change in TSK score | 2.5 (8.3) | 3.6 (11.2) | 1.58 (0.53 to 2.62)b | .006 |
| Anxiety: change in HADS subscale score | 1.0 (44) | 1.2 (4.7) | 0.34 (−0.29 to 0.97)b | .27 |
| Depression: change in HADS subscale score | 1.0 (40) | 1.4 (3.7) | 0.46 (−0.07 to 0.98)b | .08 |
| Mental health: change in SF12 MCS score | −1.9 (14.3) | −2.1 (13.7) | −0.56 (−2.77 to 1.64)b | .58 |
| Pain self-efficacy: change in PSEQ score | −7.6 (12.8) | −7.2 (15.5) | −0.45 (−2.16 to 1.26)b | .60 |
| Global change from baseline, No. (%) | ||||
| Completely recovered | 38 (10) | 63 (11) | 1.22 (0.93 to 1.59)d | .16 |
| Much better | 102 (28) | 178 (32) | ||
| Better | 88 (24) | 129 (23) | ||
| No change | 95 (26) | 127 (23) | ||
| Worse/much worse | 45 (12) | 57 (10) | ||
| Risk group, No. (%) | ||||
| Low | 240 (65) | 404 (73) | 1.49 (1.05 to 2.12)d | .03 |
| Medium | 96 (26) | 122 (22) | ||
| High | 32 (9) | 28 (5) | ||
| Work losse | ||||
| Absenteeism: days off work since baseline | 7.9 (23.5) | 4.3 (14.5) | 0.47 (0.24 to 0.92)f | .03 |
| Presenteeism: reduced productivity at work | 2.2 (2.5) | 2.0 (2.5) | 0.17 (−0.42 to 0.75)b | .57 |
| Satisfaction with care received, No. (%)g | ||||
| Satisfied | 161 (71) | 215 (70) | 1.15 (0.84 to 1.59)d | .39 |
| Neutral | 23 (10) | 41 (13) | ||
| Not satisfied | 44 (19) | 52 (17) | ||
| Satisfaction with results of care, No. (%)g | ||||
| Very satisfied/satisfied | 133 (59) | 209 (70) | 1.50 (1.04 to 2.16)d | .03 |
| Neutral | 39 (17) | 45 (15) | ||
| Not satisfied | 52 (23) | 46 (15) | ||
CSQ-CAT = Coping Strategies Questionnaire – CATastrophizing subscale; HADS = Hospital Anxiety and Depression Scale; MCID = minimal clinically important difference; MCS = Mental Component Subscale; PCS = Physical Component Subscale; PSEQ = Pain Self-Efficacy Questionnaire; RMDQ = Roland and Morris Disability Questionnaire; SF-12 = Short Form 12; TSK = Tampa Scale of Kinesiophobia.
Note: Values are mean (SD) unless otherwise noted.
↵a Effect estimate and 95% confidence interval derived by regression analyses adjusted for age, sex, general practice, baseline RMDQ, duration of pain, and corresponding baseline value.
↵b Mean difference derived by linear regression.
↵c Based on an MCID (≥30% reduction in RMDQ score from baseline and rating of “completely recovered” or “much better” or “better” according to the global change question).
↵d Odds ratio derived by binary/ordinal logistic regression.
↵e Based on 290 of 547 respondents who reported being currently employed at 6-month follow-up.
↵f Incidence rate ratio derived by robust Poisson regression.
↵g Based on 536 respondents for the care received question and 524 for the results of care question at the 6-month follow-up.