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Table 4 Change in control group outcome scores from baseline and the basis for sample size calculations

From: A feasibility randomised controlled trial of a Fibromyalgia Self-management Programme for adults in a community setting with a nested qualitative study (FALCON)

Outcome

Week 6

Month 6

Sample Size

Change Values,

mean ± SD (n)

95% CI

Change Values,

mean ± SD (n)

95% CI

6 weeks

6 months

FIQR (max 100)

−1.03 ± 11.28 (n = 27)

1.86 ± 9.81 (n = 23)

n = 294 (147 per group)

n = 266 (133 per group)

ASES-8-8 (max 10)

0.13 ± 1.26 (n = 28)

-

−0.30 ± 1.99 (n = 25)

n = 266 (133 per group)

n = 266 (133 per group)

CFS (max 33)

−1.86 ± 6.68 (n = 28)

−1.94 ± 6.76 (n = 24)

n = 440 (220 per group)

n = 346 (173 per group)

SF36 RP (max 100)

6.25 ± 24.18 (n = 28)

17.00 ± 34.40 (n = 25)

n = 1054 (527 per group)

n = 1870 (935 per group)

SF36 SF (max 100)

−3.57 ± 16.27 (n = 28)

2.08 ± 19.39 (n = 24)

n = 1054 (527 per group)

n = 1458 (729 per group)

SF36 BP (max 100)

−3.84 ± 18.49 (n = 28)

-

−0.70 ± 15.13 (n = 25)

n = 732 (366 per group)

n = 388 (194 per group)

  1. Revised Fibromyalgia Impact Question (FIQR), Arthritis Self-Efficacy Scale-8 (ASES-8), Chalder Fatigue Scale (CFS), Short Form 36 Role Physical (SF36 RP), Short Form 36 Social Functioning (SF36 SF), Short Form 36 Bodily Pain (SF36 BP)