Table 4 Primary and secondary outcomes measured at baseline, 8 and 20 weeks with between-group comparisons based on intention-to-treat principle
Outcome | Treatment group Mean (SD) | Adjusted between-group difference Mean (95% CI) | ||||
|---|---|---|---|---|---|---|
PE + MCE | PE | MCE | PE + MCE vs PE | PE + MCE vs MCE | PE vs MCE | |
Primary outcomes | ||||||
NPRS (0–10) | ||||||
Baseline | 6.20 (1.71) | 6.25 (1.83) | 5.80 (1.63) | – | – | – |
8 weeks | 3.08 (1.65) | 4.23 (1.70) | 3.48 (1.73) | –1.15 (–2.04 to –0.25)b | –0.40 (–1.29 to 0.49) | 0.75 (0.14 to 1.64) |
20 weeks | 2.93 (1.62) | 4.18 (1.73) | 3.33 (1.54) | –1.25 (–2.14 to –0.35)b | –0.40 (–1.29 to 0.49) | 0.85 (–0.04 to 1.74) |
ODI (0–100) | ||||||
Baseline | 23.4 (12.5) | 25.2 (14.5) | 23.8 (12.1) | – | – | – |
8 weeks | 13.7 (6.77) | 18.8 (10.7) | 13.1 (7.21) | –5.04 (–9.57 to –0.52)a | 0.63 (–3.88 to 5.16) | 5.68 (1.15 to 10.2)b |
20 weeks | 11.6 (5.12) | 17.6 (9.99) | 11.0 (5.58) | –5.96 (–9.84 to –2.07)b | 0.61 (–3.26 to 4.49) | 6.57 (2.69 to 10.4)b |
Secondary outcomes | ||||||
PCS-12 (0–100) | ||||||
Baseline | 35.1 (8.36) | 35.2 (8.05) | 35.9 (7.97) | – | – | – |
8 weeks | 43.3 (7.84) | 41.7 (7.99) | 43.4 (7.43) | 1.60 (–1.66 to 4.86) | –0.16 (–3.41 to 3.10) | –1.76 (–5.02 to 1.50) |
20 weeks | 45.5 (6.85) | 44.5 (6.82) | 45.6 (5.92) | 1.03 (–2.23 to 4.29) | –0.13 (–3.40 to 3.13) | –1.16 (–4.43 to 2.10) |
MCS-12 (0–100) | ||||||
Baseline | 41.4 (8.19) | 40.9 (10.9) | 43.0 (9.01) | – | – | – |
8 weeks | 46.2 (6.59) | 47.8 (9.20) | 47.6 (6.11) | –1.55 (–5.01 to 1.90) | –1.43 (–4.89 to 2.01) | 0.11 (–3.34 to 3.57) |
20 weeks | 46.6 (6.21) | 45.2 (7.81) | 46.6 (6.08) | 1.20 (–4.66 to 2.25) | –0.14 (–3.60 to 3.30) | –1.35 (–4.80 to 2.10) |
GRCS (–5 to + 5) | ||||||
Baseline | –1.25 (1.94) | –1.35 (1.81) | –1.25 (1.82) | – | – | – |
8 weeks | 1.92 (2.12) | 1.80 (1.97) | 2.05 (1.99) | 0.12 (–0.71 to 0.96) | –0.12 (0.96 to 0.71) | –0.25 (–1.09 to 0.59) |
20 weeks | 2.20 (2.22) | 1.35 (1.71) | 1.82 (1.72) | 0.85 (0.00 to 1.69) | 0.37 (–0.46 to 1.21) | –0.47 (–1.31 to 0.36) |
FABQ-PA (0–24) | ||||||
Baseline | 11.6 (7.24) | 13.7 (6.93) | 13.9 (6.53) | – | – | – |
8 weeks | 6.78 (5.44) | 9.98 (5.46) | 9.35 (5.25) | –3.20 (–5.71 to –0.68)a | –2.57 (–5.09 to –0.05)a | 0.62 (–1.89 to 3.14) |
20 weeks | 6.28 (4.76) | 7.77 (4.87) | 8.40 (4.95) | –1.49 (–4.01 to 1.01) | –2.12 (–4.64 to 0.39) | –0.62 (–3.14 to 1.89) |
FABQ-W (0–42) | ||||||
Baseline | 24.5 (8.15) | 24.3 (8.45) | 21.6 (10.5) | – | – | – |
8 weeks | 17.2 (7.70) | 15.1 (8.65) | 15.2 (7.37) | 2.10 (–1.39 to 5.59) | 2.02 (–1.46 to 5.51) | –0.07 (–3.56 to 3.41) |
20 weeks | 15.0 (7.46) | 12.5 (7.17) | 11.7 (5.97) | 3.17 (–0.31 to 6.66) | 3.57 (0.08 to 7.06) | 0.39 (–3.09 to 3.89) |
PCS (0–52) | ||||||
Baseline | 31.3 (8.03) | 29.2 (7.58) | 31.0 (8.69) | – | – | – |
8 weeks | 22.1 (7.74) | 17.2 (7.02) | 19.8 (6.97) | 4.85 (1.69 to 8.01)b | 2.25 (–0.91 to 5.41) | –2.60 (–5.76 to 0.56) |
20 weeks | 20.4 (7.23) | 15.3 (6.57) | 18.3 (4.95) | 5.15 (1.99 to 8.31)b | 2.16 (–0.99 to 5.32) | –2.98 (–6.14 to 0.17) |
BBQ (9–45) | ||||||
Baseline | 17.5 (5.07) | 17.9 (5.50) | 18.4 (5.63) | – | – | – |
8 weeks | 25.6 (6.68) | 28.2 (7.44) | 24.4 (6.28) | –2.60 (–5.37 to 0.15) | –1.21 (–1.54 to 3.98) | 3.82 (1.06 to 6.58)b |
20 weeks | 26.4 (6.90) | 30.1 (7.25) | 25.6 (6.01) | –3.74 (–6.50 to –0.98)b | 0.78 (–1.97 to 3.54) | 4.52 (1.76 to 7.29)b |
Pain medication use | ||||||
Baseline | 10.0 (8.14) | 9.10 (6.81) | 11.2 (8.51) | – | – | – |
8 weeks | 5.05 (6.77) | 9.37 (7.68) | 7.10 (7.00) | –4.32 (–7.59 to –1.05)a | –2.05 (–5.32 to 1.22) | 2.27 (–0.99 to 5.54) |