Table 2

Mean (SD) change in score of SPADI, PET, overall pain, and range of motion measures for active and placebo groups and difference in mean change (95% CI) between groups at 3, 6, and 12 weeks

Outcome measure (maximum score)3 Weeks (active n = 25, placebo n = 21)6 Weeks (active n = 25, placebo n = 21, 17)12 Weeks (active n = 25, placebo n = 21, 17)Across all time points (active n = 25, placebo n = 17)
Mean change (SD)*Difference in mean change between groups (95% CI)†Mean change (SD)Difference in mean change between groups (95% CI)Mean change (SD)Difference in mean change between groups (95% CI)p Value for homogeneity**Pooled difference between groups (95% CI)‡
*Positive change indicates improvement, negative change indicates worsening; †positive difference in mean change indicates active treatment group improved more than placebo group; ‡pooled difference between groups across all times by repeated measures analysis of covariance; §intention to treat; ¶97.1% confidence interval for SPADI at 3 weeks due to interim analysis using 2.9% significance level; **p value for test of homogeneity of difference between groups over time. If p<0.05 then no pooled result provided.
Shoulder Pain and Disability Index Score (100)
Active21.8 (19.3)21.6 (23.0)28.7 (23.9)
Placebo (ITT)§4.7 (19.8)17.1 (4.0 to 30.1)¶16.6 (21.4)5.1 (−7.7 to 17.9)24.3 (25.8)0.3 (−15.8 to 16.1)0.008
Placebo (excluding four withdrawals)8.0 (14.4)13.5 (1.8 to 25.3)29 (25.3)4.4 (−12.6 to 21.4)0.03
Problem Elicitation Technique Score (500)
Active62.5 (75.5)71.3 (81)107.7 (74.2)
Placebo (ITT)8.7 (29.0)53.8 (7.5 to 89.9)25.3 (34.4)45.9 (3.2 to 88.7)53.3 (70.3)54.4 (3.8 to 104.9)0.5947.7 (13.2 to 81.7)
Placebo (excluding four withdrawals)14.8 (28.9)56.5 (17.4 to 95.6)46.6 (75.5)61 (4.3 to 117)0.8853.0 (18.3 to 87.8)
Overall pain (10)
Active2.5 (2.5)2.4 (2.7)3.1 (2.4).
Placebo (ITT)0.2 (1.7)2.3 (1.0 to 3.6)1 (2.4)1.5 (−0.1 to 3.1)2.4 (2.8)0.8 (−2.5 to 0.9)0.015
Placebo (excluding four withdrawals)0.2 (1.7)2.2 (0.8 to 3.6)2.0 (2.8)1.2 (−0.6 to 3.0)0.161.8 (0.7 to 2.9)
Total shoulder flexion (180 degrees)
Active6.9 (18.4)11.4 (15.9)15.4 (21.6)
Placebo (ITT)−0.9 (23.5)7.9 (−5.2 to 20.9)10.5 (25.5)1 (−12.3 to 14.3)19.2 (26.7)−3.8 (−20.7 to 13)0.171.4 (0.3 to 2.5)
Placebo (excluding four withdrawals)7.1 (26.2)4.3 (−10.7 to 19.3)17.7 (28.2)−2.3 (−22.1 to 17.5)0.186.8 (−3.2 to 16.8)
Total shoulder abduction (180 degrees)
Active20.2 (30.2)24.4 (34.2)32.8 (38.1)
Placebo (ITT)−0.2 (22.5)20.4 (4.6 to 36.3)15.5 (26.1)8.8 (−9.3 to 26.9)28.3 (29.9)4.5 (−18.5 to 27.6)0.1315.5 (1.1 to 30.0)
Placebo (excluding four withdrawals)9.1 (23)15.2 (−2.9 to 33)26.8 (28.5)6.0 (−18.2 to 30.2)0.1017.7 (3.4 to 32.1)
External rotation in neutral (90 degrees)
Active9 (18.5)8.8 (28)19.9 (27.9)
Placebo (ITT)3.2 (19.9)5.7 (−6, 17.5)15.3 (33.7)−6.5 (−25.4, 12.5)17.8 (29.2)2.1 (−17.4 to 21.7)0.603.3 (−5.5 to 12.1)
Placebo (excluding four withdrawals)11.6 (32.1)−2.8 (−21.3, 15.6)10.8 (28)9.1 (−12 to 30.2)0.535.3 (−3.4 to 13.9)
Hand behind back
Active3.2 (3.7)3.4 (4.3)4.2 (4.4)
Placebo (ITT)−0.2 (3.8)3.4 (1.1, 5.7)1.5 (4.8)−1.8 (−4.5 to 1)3.4 (5.0)−0.8 (−4 to 2.5)0.007
Placebo (excluding four withdrawals)1.3 (4)2.1 (−0.6 to 4.8)4.2 (4.4)00.010