Table 3

 Improvement in outcomes at three weeks, six weeks, and 12 weeks compared with baseline: intention to treat analysis

3 Weeks (active n = 24, placebo n = 25)6 Weeks (active n = 24, placebo n = 24)12 Weeks (active n = 24, placebo n = 22)p Value interaction (time×treatment)
Mean change (SD)*†Adjusted Δ (95% CI)‡p ValueMean change (SD)Adjusted Δ (95% CI)p ValueMean change (SD)Adjusted Δ (95% CI)p Value
Overall pain
    Active4.1 (2.3)2.4 (1.1 to 3.8)0.0013.7 (3.0)0.8 (−0.8 to 2.3)0.3133.5 (3.1)−1.5 (−3.1 to 0.2)0.0750.001
    Placebo1.4 (2.4)2.5 (2.7)4.2 (2.7)
Night pain
    Active4.7 (3.2)3.1 (1.7 to 4.5)0.0003.9 (3.6)0.8 (−1.0 to 2.5)0.3873.3 (3.8)−1.3 (−3.1 to 0.5)0.140<0.001
    Placebo1.0 (2.5)0.0002.5 (3.3)4.0 (3.2)
Movement pain
    Active4.3 (2.6)2.5 (1.2 to 3.8)0.0003.7 (3.3)0.8 (−0.8 to 2.4)0.3143.3 (2.8)−1.9 (−3.5 to −0.3)0.020<0.001
    Placebo1.9 (2.4)3.0 (2.3)5.2 (2.5)
SPADI
    Active29.0 (20.4)17.1 (6.4 to 27.9)0.00232.2 (24.8)6.4 (−6.9 to 19.6)0.33929.1 (26.1)−13.5 (−27.1 to 0.2)0.053<0.001
    Placebo10.9 (17.0)24.6 (20.5)38.9 (21.2)
Croft
    Active5.0 (3.5)4.2 (2.0 to 6.3)0.0004.9 (4.4)0.9 (−1.6 to 3.5)0.4634.0 (5.4)−2.9 (−5.9 to −0.02)0.049<0.001
    Placebo0.7 (3.9)3.8 (4.3)6.2 (4.8)
HAQ disability
    Active0.6 (0.8)0.38 (0.04 to 0.7)0.0320.7 (0.8)0.3 (−0.08 to 0.6)0.1360.5 (0.6)−0.3 (−0.59 to −0.01)0.045<0.001
    Placebo0.1 (0.4)0.2 (0.6)0.7 (0.6)
DASH
    Active18.4 (12.2)15.1 (6.4 to 23.7)0.00118.9 (13.5)4.6 (3.9 to 13.2)0.28112.9 (19.2)−10.1 (−22.2 to 2.0)0.100<0.001
    Placebo1.8 (18.5)12.7 (16.6)20.8 (21.9)
Total shoulder flexion
    Active25.1 (22.4)16.5 (4.0 to 29.0)0.01117.3 (25.3)−8.4 (−21.5 to 4.7)0.20313.2 (29.9)−29.3 (−49.2 to −9.3)0.0050.001
    Placebo4.8 (24.7)16.5 (4.0 to 29.0)0.01120.1 (28.4)−8.4 (−21.5 to 4.7)0.20337.5 (34.6)−29.3 (−49.2 to −9.3)0.0050.001
Total shoulder abduction
    Active24.3 (21.4)20.9 (8.7 to 33.1)0.00118.4 (28.9)−4.3 (−21.8 to 13.1)0.61818.7 (29.9)−21.2 (−40.9 to −1.5)0.035<0.001
    Placebo(21.3)20.9 (8.7 to 33.1)0.00118.0 (34.9)0.61835.8 (38.6)0.035<0.001
External rotation
    Active10.4 (18.5)3.4 (−8.6 to 15.4)0.5695.9 (22.8)−2.0 (−15.2 to 11.2)0.7649.8 (28.0)−6.0 (−21.2 to 9.2)0.4300.577
    Placebo6.4 (25.0)7.1 (30.2)13.0 (32.3)
Hand behind back
    Active2.8 (3.3)2.2 (0.5 to 3.7)0.0133.7 (4.4)1.3 (−1.2 to 3.8)0.3013.3 (4.8)−1.2 (−3.7 to 1.4)0.3670.001
    Placebo0.8 (2.1)2.5 (3.7)4.5 (3.4)
SF-36
Physical function7.4 (14.6)(−6.4 to 12.4)0.52113.5 (16.4)2.3 (−9.5 to 14.1)0.6999.0 (21.0)−5.1 (−20.1 to 10.0)0.5030.534
    Active3.6 (19.7)10.5 (25.5)12.5 (32.6)
    Placebo
Social function
    Active7.5 (23.4)1.2 (−9.9 to 12.3)0.8289.3 (27.7)−5.4 (−17.2 to 6.4)0.36312.5 (23.6)2.5 (−9.6 to 14.7)0.6760.624
    Placebo8.6 (23.9)1.2 (−9.9 to 12.3)0.82817.2 (26.6)9.8 (27.8)2.5 (−9.6 to 14.7)0.676
Role emotion
    Active12.8 (50.2)14.7 (−9.8 to 39.2)0.23216.0 (51.1)7.0 (−17.0 to 31.1)0.55813.1 (55.9)−5.7 (−29.6 to 18.2)0.6330.476
    Placebo−9.7 (45.6)14.7 (−9.8 to 39.2)0.2320.9 (49.4)7.6 (43.5)
Bodily pain
    Active20.2 (19.3)14.5 (5.2 to 23.9)0.00324.3 (23.6)5.8 (−7.2 to 18.8)0.37128.0 (25.7)−4.3 (−19.4 to 10.8)0.5710.121
    Placebo4.2 (13.6)14.5 (5.2 to 23.9)0.00315.8 (23.0)28.2 (27.8)
Mental health
    Active6.3 (16.6)4.4 (−3.6 to 12.4)0.27010.5 (19.4)0.7 (−8.4 to 9.8)0.87513.7 (20.4)5.3 (−4.2 to 14.9)0.2660.609
    Placebo1.4 (13.58.6 (18.3)6.6 (14.2)
Vitality
    Active9.4 (16.5)6.5 (−3.0 to 16.0)0.1737.9 (18.2)−2.3 (−12.7 to 8.1)0.66217.2 (27.9)1.8 (−12.6 to 16.2)0.8010.447
    Placebo1.6 (18.1)8.8 (18.9)−2.3 (−12.7 to 8.1)12.3 (25.4)
General health
    Active2.5 (14.0)5.3 (−2.3 to 13.0)0.169−6.5 (24.2)−6.5 (−18.5 to 5.6)0.285−2.2 (14.0)1.6 (−10.4 to 13.6)0.7900.335
    Placebo−3.2 (12.4)−1.0 (17.5)−4.5 (24.7)
n/N (%)RR (95% CI)n/N (%)RR (95% CI)n/N (%)RR (95% CI)
*Positive change indicates improvement, negative change indicates worsening.
†Adjusted for baseline value.
‡Positive difference in mean change indicates active treatment group improved more than placebo group.
¶Relative risk (95% confidence intervals).
§Risk difference (95% CI).
CI, confidence interval; DASH, disabilities arm shoulder and hand; HAQ, health assessment questionnaire; RR, relative risk; SF-36, short form 36 item health survey; SPADI, shoulder pain and disability index; Δ, difference in mean change between groups.
Patient reported success
    Active22/23 (97.7)2 (1.3 to 3.1)0.00116/23 (69.6)0.9 (0.6 to 1.3)0.92817/23 (73.9)0.8 (0.6 to 1.1)0302
    Placebo11/23 (47.8)18/24 (75.0)19/21 (90.5)
RD (95% CI)§RD (95% CI)RD (95% CI)
48 (26 to 70)<0.001−5 (−31 to 20)0.752−17 (−39 to 5)0.245