Skip to main content

Table 3 Intention to treat analysis—difference between group means (95% CI for difference) for primary outcome

From: Comparison of supervised exercise therapy with or without biopsychosocial approach for chronic nonspecific low back pain: a randomized controlled trial

Primary outcome

Graded Activity (N = 58)

Supervised Exercise Therapy (N = 63)

Control (N = 59)

Group comparison

GA vs Control

 

SET vs Control

 

GA vs SET

 

M (SD)

M (SD)

M (SD)

Mean difference (95% CI)

p value‡

Mean difference (95% CI)

P value‡

Mean difference (95% CI)

p value‡

Pain (VAS; 0 = best, 100 = worst)

 Baseline

58.9 (11.6)

58.5 (12.7)

60.5 (14.7)

      

 Post-intervention

36.4 (13.4)

37.9 (16.8)

59.0 (13.3)

      

  Sensitivity analysisa

   

−22.64 (−29.19 to −16.10)

< 0.0001

− 21.08 (−27.52 to − 14.64)

< 0.0001

−1.56 (−7.98 to 4.85)

1.0000

  Sensitivity analysisb

   

−19.94 (−25.14 to − 14.74)

< 0.0001

−19.23 (− 24.32 to − 14.13)

< 0.0001

−0.72 (−5.78 to 4.35)

1.000

  Effect size (95% CI)c

   

1.70 (1.28 to 2.12)

 

1.39 (0.99 to 1.79)

 

0.10 (−0.25 to 0.46)

 

 3 month

35.4 (14.1)

41.9 (14.9)

54.1 (11.1)

      

  Sensitivity analysisa

   

−18.73 (−24.78 to −12.68)

< 0.0001

− 12.16 (− 18.11 to −6.21)

< 0.0001

−6.57 (− 12.49 to − 0.64)

0.024

  Sensitivity analysisb

   

−16.85 (− 22.25 to − 11.44)

< 0.0001

−10.87 (− 16.17 to − 5.57)

< 0.0001

−5.98 (− 11.24 to − 0.71)

0.020

  Effect size (95% CI)c

   

1.47 (1.06 to 1.88)

 

0.93 (0.55 to 1.30)

 

0.45 (0.09 to 0.81)

 

 6 month

37.2 (12.3)

43.8 (14.5)

56.2 (13.4)

      

  Sensitivity analysisa

   

−19.00 (−25.02 to − 12.99)

< 0.0001

−12.42 (− 18.34 to −6.50)

< 0.0001

− 6.58 (− 12.47 to − 0.69)

0.023

  Sensitivity analysisb

   

−17.35 (− 22.89 to −11.81)

< 0.0001

− 11.29 (−16.71 to −5.86)

< 0.0001

− 6.06 (− 11.45 to − 0.68)

0.022

  Effect size (95% CI)c

   

1.48 (1.07 to 1.89)

 

0.89 (0.52 to 1.26)

 

0.49 (0.13 to 0.85)

 
  1. ‡ Bonferroni corrected/adjusted p-value
  2. aBased on intention-to-treat analysis
  3. bBased on intention-to-treat analysis and adjustment for age (< 40; ≥40), sex, baseline pain, RMDQ score (< 14;≥14), Depression score (≤10, ≥11);
  4. cCohen’s d computed as the mean difference relative to pooled SD of baseline scores; 0.1 was considered a no effect, 0.2 a small effect, 0.5 a moderate effect, 0.8 a large effect