Table 3.
Changes in the Roland-Morris Disability, McGill Pain and SF-12 questionnaires between groups at follow-up (N = 501)
| Control Group (n = 239) | Intervention Group (n = 262) | Difference (95%CI) between group (IG - CG) | ||||||
|---|---|---|---|---|---|---|---|---|
| Value | Difference*(95% CI) | Value | Difference*(95% CI) | change IG - CG | P-value | Adjusted difference** | P-value | |
| RMDQ, mean (SD) | ||||||||
| Baseline | 9.9 (5.3) | 10.0 (5.2) | ||||||
| three months | 7.4 (5.5) | −2.3 (−3.1 to −1.6) | 6.2 (4.9) | −3.8 (−4.5 to −3.2) | −1.5 (− 2.5 to −0.5) | 0.003* | −1.33 (− 2.22 to − 0.45) | 0.005* |
| 12 months | 6.0 (5.7) | −3.8 (− 4.8 to − 2.9) | 5.1 (4.9) | −5.1 (−5.8 to − 4.3) | − 1.2 (− 2.4 to − 0.0) | 0.043* | −1.11 (− 2.08 to − 0.13) | 0.027* |
| MPQ | ||||||||
| Total intensity score, mean (SD) | ||||||||
| Baseline | 6.5 (3.1) | 6.7 (3.1) | ||||||
| three months | 4.6 (3.6) | −1.8 (−2.3 to − 1.3) | 4.0 (3.6) | − 2.7 (− 3.2 to − 2.2) | − 0.9 (− 1.6 to − 0.1) | 0.022* | −0.49 (− 1.39 to 0.42) | 0.294 |
| 12 months | 3.6 (3.6) | −2.8 (− 3.3 to − 2.2) | 3.1 (3.2) | −3.6 (− 4.1 to − 3.0) | − 0.8 (− 1.6 to 0.0) | 0.040* | −0.69 (− 1.41 to 0.02) | 0.058** |
| Current Intensity score mean (SD) | ||||||||
| Baseline | 2.6 (1.1) | 2.5 (1.2) | ||||||
| three months | 1.7 (1.5) | −0.9 (− 1.1 to − 0.7) | 1.3 (1.4) | −1.2 (− 1.4 to − 1.0) | −0.3 (− 0.6 to 0.0) | 0.083 | −0.32 (− 0.63 to − 0.02) | 0.040* |
| 12 months | 1.6 (1.4) | −1.1 (− 1.3 to 0.8) | 1.4 (1.3) | −1.1 (− 1.3 to − 0.9) | 0.0 (−0.3 to 0.3) | 0.854 | −0.18 (− 0.43 to 0.08) | 0.162 |
| VAS, mean (SD) | ||||||||
| Baseline | 5.9 (2.3) | 5.8 (2.3) | ||||||
| three months | 4.1 (3.3) | −1.8 (−2.2 to − 1.3) | 3.2 (3.2) | − 2.7 (−3.1 to − 2.2) | −0.9 (− 1.6–0.3) | 0.004* | −0.77 (− 1.53 to − 0.01) | 0.046* |
| 12 months | 3.9 (3.2) | −2.0 (− 2.5 to − 1.5) | 3.6 (3.0) | −2.3 (− 2.7 to − 1.9) | − 0.3 (− 0.9 to 0.4) | 0.404 | −0.27 (− 0.88 to 0.34) | 0.374 |
| SF-12 Physical health, mean (SD) | ||||||||
| Baseline | 40.7 (9.3) | 41.9 (9.0) | ||||||
| three months | 45.3 (9.8) | 4.2 (2.7 to 5.6) | 46.5 (8.7) | 4.5 (3.2 to 5.8) | 0.4 (− 1.6 to 2.3) | 0.716 | 0.55 (− 1.19 to 2.29) | 0.520 |
| 12 months | 46.2 (9.5) | 5.0 (3.3 to 6.7) | 47.0 (8.9) | 4.9 (3.5 to 6.3) | −0.1 (−2.3 to 2.1) | 0.922 | 0.53 (−1.20 to 2.27) | 0.532 |
| SF-12 Mental health, mean (SD) | ||||||||
| Baseline | 42.3 (12.4) | 43.4 (12.8) | ||||||
| three months | 45.0 (13.2) | 2.6 (0.7 to 4.6) | 48.8 (12.0) | 5.1 (3.4 to 6.9) | 2.5 (−0.1 to 5.0) | 0.061 | 2.56 (− 0.33 to 5.45) | 0.082 |
| 12 months | 47.0 (11.9) | 5.0 (2.9 to 7.1) | 48.9 (11.2) | 5.5 (3.6 to 7.5) | 0.5 (−2.3 to 3.4) | 0.707 | 1.48 (−0.86 to 3.83) | 0.206 |
Abbreviations: SD standard deviation, CI confidence interval, RMDQ Roland-Morris Disability Questionnaire (scale 0–24; lower scores indicate less disability), MGPQ McGill pain questionnaire; 3 dimensions (sensorial, affective and evaluative) with Total Intensity Score (scale 0–14), Current Intensity Score (scale 0–5) and Visual Analogical Scale (VAS, scale 0–10); SF-12 = 12-item short-form health survey version 1 (scale 0–100; lower scores indicate worse health related quality of life). * Differences were calculated between follow-up and baseline measurements. Mean differences are shown for quantitative outcomes and percentage differences for dichotomous outcomes. **All models were adjusted for the score at baseline, significant confounders and significant interaction variables. Intervention group minus usual care group, mean differences are shown for quantitative outcomes and odds ratios for dichotomous outcomes. Intervention group minus usual care group, mean differences are shown for quantitative outcomes and odds ratios for dichotomous outcomes. Total Intensity Score, VAS Pain Score and Mental Health were estimated with a mixed model considering the PHCC as random effect