Table 3 Primary and Secondary Patient-rated Outcomes
|  | SMT + HEP | SEP + HEP | HEP | SMT + HEP minus HEP | SEP + HEP minus HEP | SMT + HEP minus SEP + HEP |
|---|---|---|---|---|---|---|
Low back pain severity [0–10] | ||||||
 Week 0 Mean (SD) | 5.07 (1.60) | 5.31 (1.45) | 5.14 (1.43) |  |  |  |
 Week 4 Mean (95% CI) | 3.90 (3.48 to 4.33) | 4.51 (4.08 to 4.94) | 4.19(3.76 to 4.62) | −0.28 (− 0.89 to 0.32) | 0.33(− 0.28 to 0.94) | − 0.61(−1.22 to − 0.01) |
 Week 12 Mean (95% CI) | 2.85 (2.43 to 3.28) | 3.25(2.82 to 3.68) | 3.64(3.20 to 4.07) | − 0.78(−1.39 to − 0.17) | − 0.39 (− 1.00 to 0.22) | −0.39 (− 1.00 to 0.21) |
 Short term Mean (95% CI) |  |  |  | −0.48 (− 1.00 to 0.03) | 0.04 (− 0.48 to 0.56) | − 0.53 (− 1.04 to − 0.01) |
 Week 26 Mean (95% CI) | 3.64 (3.21 to 4.07) | 3.58 (3.15 to 4.01) | 3.52 (3.08 to 3.95) | 0.12 (− 0.49 to 0.73) | 0.06 (− 0.56 to 0.67) | 0.06 (− 0.55 to 0.67) |
 Week 52 Mean (95% CI) | 3.81 (3.39 to 4.24) | 3.94 (3.51 to 4.37) | 3.68 (3.25 to 4.12) | 0.13 (− 0.48 to 0.74) | 0.26 (− 0.35 to 0.87) | − 0.13 (− 0.74 to 0.48) |
 Long term Mean (95% CI) |  |  |  | −0.13 (− 0.59 to 0.34) | 0.04 (− 0.43 to 0.52) | − 0.17 (− 0.64 to 0.30) |
Omnibus test for differences in long term longitudinal profile for pain severity (weeks 4 through 52) between groups P-value = 0.76 | ||||||
Low back disability (Roland Morris) [0–100] | ||||||
 Week 0 Mean (SD) | 45.5 (20.9) | 42.9 (17.9) | 45.3 (16.5) |  |  |  |
 Week 4 Mean (95% CI) | 36.2 (32.4 to 40.0) | 34.2 (30.4 to 38.0) | 34.8 (31.0 to 38.6) | 1.38 (−3.99 to 6.75) | −0.60 (−6.01 to 4.81) | 1.98 (− 3.39 to 7.36) |
 Week 12 Mean (95% CI) | 29.9 (26.1 to 33.7) | 25.3 (21.5 to 29.1) | 30.0 (26.1 to 33.9) | −0.13 (−5.56 to 5.29) | −4.70 (−10.15 to 0.74) | 4.57 (− 0.83 to 9.97) |
 Short term Mean (95% CI) |  |  |  | 0.78 (−3.99 to 5.54) | −2.24 (−7.04 to 2.55) | 3.02 (−1.75 to 7.78) |
 Week 26 Mean (95% CI) | 30.0 (26.2 to 33.9) | 31.1 (27.3 to 35.0) | 34.8 (31.0 to 38.7) | −4.81 (−10.25 to 0.63) | −3.70 (−9.16 to 1.76) | − 1.11 (−6.55 to 4.33) |
 Week 52 Mean (95% CI) | 34.3 (30.5 to 38.1) | 33.4 (29.5 to 37.2) | 32.9 (29.0 to 36.8) | 1.41 (−4.04 to 6.85) | 0.45 (−5.00 to 5.90) | 0.96 (−4.45 to 6.36) |
 Long term Mean (95% CI) |  |  |  | −1.42 (−5.88 to 3.04) | −2.47 (−6.95 to 2.01) | 1.05 (−3.40 to 5.50) |
Omnibus test for differences in long term longitudinal profile for disability (weeks 4 through 52) between groups P-value = 0.56 | ||||||
 Improvement [1–9] | ||||||
 Week 4 Mean (95% CI) | 3.85 (3.55 to 4.16) | 3.84 (3.52 to 4.15) | 3.91 (3.6 to 4.22) | − 0.06 (− 0.5 to 0.38) | −0.08 (− 0.52 to 0.36) | 0.02 (− 0.42 to 0.45) |
 Week 12 Mean (95% CI) | 3.11 (2.80 to 3.42) | 3.00 (2.69 to 3.31) | 3.34 (3.02 to 3.65) | − 0.23 (− 0.67 to 0.21) | −0.34 (− 0.78 to 0.1) | 0.11 (− 0.33 to 0.55) |
 Short term Mean (95% CI) |  |  |  | −0.13 (− 0.51 to 0.26) | −0.18 (− 0.57 to 0.21) | 0.05 (− 0.33 to 0.44) |
 Week 26 Mean (95% CI) | 3.43 (3.12 to 3.75) | 3.38 (3.07 to 3.7) | 3.54 (3.23 to 3.86) | − 0.11 (− 0.55 to 0.33) | −0.16 (− 0.6 to 0.28) | 0.05 (− 0.39 to 0.49) |
 Week 52 Mean (95% CI) | 3.72 (3.41 to 4.03) | 3.54 (3.23 to 3.86) | 3.64 (3.33 to 3.96) | 0.07 (− 0.37 to 0.51) | −0.1 (− 0.54 to 0.34) | 0.17 (− 0.27 to 0.61) |
 Long term Mean (95% CI) |  |  |  | −0.08 (− 0.45 to 0.28) | −0.17 (− 0.54 to 0.19) | 0.09 (− 0.27 to 0.45) |
Omnibus test for differences in long term longitudinal profile for improvement (weeks 4 through 52) between groups P-value = 0.65 | ||||||
Satisfaction [1–7] | ||||||
 Week 4 Mean (95% CI) | 1.93 (1.72 to 2.14) | 1.77 (1.56 to 1.98) | 2.35 (2.14 to 2.57) | −0.43 (− 0.73 to − 0.13) | −0.58 (− 0.88 to − 0.28) | 0.15 (− 0.15 to 0.45) |
 P-value |  |  |  | 0.005 | < 0.001 | 0.31 |
 Week 12 Mean (95% CI) | 1.86 (1.65 to 2.08) | 1.68 (1.47 to 1.9) | 2.38 (2.17 to 2.6) | −0.52 (− 0.82 to − 0.22) | −0.7 (− 1 to − 0.4) | 0.18 (− 0.12 to 0.48) |
 P-value |  |  |  | 0.001 | < 0.001 | 0.24 |
 Short term Mean (95% CI) |  |  |  | −0.46 (− 0.74 to − 0.19) | −0.63 (− 0.9 to − 0.36) | 0.16 (− 0.11 to 0.44) |
 P-value |  |  |  | < 0.001 | < 0.001 | 0.23 |
 Week 26 Mean (95% CI) | 2.07 (1.86 to 2.29) | 1.82 (1.61 to 2.04) | 2.46 (2.25 to 2.68) | −0.39 (− 0.69 to − 0.09) | −0.64 (− 0.94 to − 0.34) | 0.25 (− 0.05 to 0.55) |
 P-value |  |  |  | 0.012 | < 0.001 | 0.10 |
 Week 52 Mean (95% CI) | 2.17 (1.96 to 2.38) | 1.87 (1.66 to 2.09) | 2.54 (2.32 to 2.75) | −0.37 (− 0.67 to − 0.06) | −0.66 (− 0.97 to − 0.36) | 0.3 (− 0.003 to 0.6) |
 P-value |  |  |  | 0.018 | < 0.001 | 0.052 |
 Long term Mean (95% CI) |  |  |  | −0.42 (− 0.67 to − 0.16) | −0.65 (− 0.91 to − 0.39) | 0.24 (− 0.02 to 0.49) |
 P-value |  |  |  | 0.002 | < 0.001 | 0.07 |
Omnibus test for differences in long term longitudinal profile for satisfaction (weeks 4 through 52) between groups P-value < 0.001 | ||||||
Medication use [0–4] | ||||||
 Week 0 Mean (SD) | 1.63 (1.50) | 1.68 (1.47) | 2.09 (1.67) |  |  |  |
 Week 4 Mean (95% CI) | 1.53 (1.25 to 1.81) | 1.52 (1.24 to 1.81) | 1.60 (1.31 to 1.88) | −0.07 (− 0.47 to 0.34) | −0.07 (− 0.48 to 0.33) | 0.01 (− 0.39 to 0.41) |
 Week 12 Mean (95% CI) | 1.51 (1.23 to 1.8) | 1.28 (1 to 1.57) | 1.61 (1.32 to 1.9) | −0.09 (− 0.5 to 0.32) | −0.32 (− 0.73 to 0.08) | 0.23 (− 0.17 to 0.63) |
 Short term Mean (95% CI) |  |  |  | −0.08 (− 0.42 to 0.27) | −0.17 (− 0.52 to 0.17) | 0.10 (− 0.24 to 0.44) |
 Week 26 Mean (95% CI) | 1.61 (1.33 to 1.9) | 1.50 (1.21 to 1.78) | 1.51 (1.22 to 1.8) | 0.1 (−0.3 to 0.51) | −0.01 (− 0.42 to 0.4) | 0.12 (− 0.29 to 0.52) |
 Week 52 Mean (95% CI) | 1.77 (1.49 to 2.06) | 1.45 (1.16 to 1.73) | 1.47 (1.18 to 1.76) | 0.3 (−0.1 to 0.71) | −0.02 (− 0.43 to 0.39) | 0.33 (− 0.08 to 0.73) |
 Long term Mean (95% CI) |  |  |  | 0.09 (−0.22 to 0.40) | −0.09 (− 0.40 to 0.22) | 0.18 (− 0.13 to 0.49) |
Omnibus test for differences in long term longitudinal profile for medication use (weeks 4 through 52) between groups P-value = 0.51 | ||||||
SF-36 PCS [0–100] | ||||||
 Week 0 Mean (SD) | 37.9 (8.7) | 39.3 (7.0) | 38.4 (7.3) |  |  |  |
 Week 4 Mean (95% CI) | 40.8 (39.4 to 42.1) | 40.8 (39.4 to 42.1) | 40.2 (38.9 to 41.5) | 0.55 (−1.33 to 2.43) | 0.55 (− 1.35 to 2.44) | 0.00 (− 1.88 to 1.88) |
 Week 12 Mean (95% CI) | 43.0 (41.7 to 44.4) | 43.8 (42.5 to 45.2) | 42.5 (41.1 to 43.8) | 0.58 (− 1.32 to 2.48) | 1.39 (−0.52 to 3.3) | − 0.81 (− 2.7 to 1.08) |
 Short term Mean (95% CI) |  |  |  | 0.56 (−1.09 to 2.21) | 0.88 (−0.77 to 2.54) | −0.32 (− 1.98 to 1.33) |
 Week 26 Mean (95% CI) | 41.7 (40.3 to 43) | 43.0 (41.7 to 44.4) | 42.0 (40.6 to 43.4) | −0.34 (− 2.24 to 1.57) | 1.02 (− 0.89 to 2.93) | −1.36 (− 3.26 to 0.55) |
 Week 52 Mean (95% CI) | 40.6 (39.2 to 41.9) | 42.3 (40.9 to 43.6) | 42.1 (40.7 to 43.4) | −1.52 (− 3.42 to 0.39) | 0.19 (− 1.72 to 2.1) | −1.70 (− 3.6 to 0.19) |
 Long term Mean (95% CI) |  |  |  | −0.34 (−1.87 to 1.2) | 0.83 (− 0.71 to 2.37) | − 1.16 (− 2.7 to 0.37) |
Omnibus test for differences in long term longitudinal profile for SF-36 PCS (weeks 4 through 52) between groups P-value = 0.31 | ||||||
SF-36 MCS [0–100] | ||||||
 Week 0 Mean (SD) | 53.9 (8.4) | 55.5 (8.2) | 55.9 (7.4) |  |  |  |
 Week 4 Mean (95% CI) | 56.7 (55.5 to 58) | 55.9 (54.6 to 57.2) | 56.3 (55 to 57.6) | 0.47 (−1.36 to 2.3) | −0.38 (−2.22 to 1.46) | 0.85 (−0.97 to 2.68) |
 Week 12 Mean (95% CI) | 56.6 (55.3 to 57.9) | 56.1 (54.8 to 57.4) | 56.5 (55.2 to 57.8) | 0.07 (−1.78 to 1.92) | −0.41 (−2.26 to 1.44) | 0.48 (− 1.35 to 2.32) |
 Short term Mean (95% CI) |  |  |  | 0.31 (−1.24 to 1.86) | −0.39 (− 1.95 to 1.16) | 0.71 (− 0.84 to 2.25) |
 Week 26 Mean (95% CI) | 56.4 (55 to 57.7) | 55.1 (53.8 to 56.4) | 54.7 (53.4 to 56.1) | 1.61 (−0.26 to 3.47) | 0.37 (−1.49 to 2.23) | 1.24 (−0.61 to 3.1) |
 Week 52 Mean (95% CI) | 54.2 (52.9 to 55.5) | 55.9 (54.6 to 57.2) | 55 (53.7 to 56.4) | −0.86 (−2.72 to 1) | 0.84 (−1.01 to 2.7) | −1.71 (−3.55 to 0.14) |
 Long term Mean (95% CI) |  |  |  | 0.49 (−1.24 to 1.86) | 0.23 (−1.18 to 1.63) | 0.26 (− 1.14 to 1.66) |
Omnibus test for differences in long term longitudinal profile for SF-36 MCS (weeks 4 through 52) between groups P-value = 0.79 | ||||||