Table 6.5Evidence profile for oral baclofen compared with placebo in children with spasticity of different severities; functioning assessment

Number of studiesNumber of participantsEffectQuality
BaclofenPlaceboRelative

(95% CI)
Absolute

(95% CI)
Mean PEDI self-care domain score at week 12 of treatment (better indicated by higher values)
1 study (Scheinberg 2006)15a15b-1.5 lowercModerate
Mean PEDI mobility domain score at week12 of treatment (better indicated by higher values)
1 study (Scheinberg 2006)15d15e-1.5 lowerfModerate
Mean PEDI social function score at week 12 of treatment (better indicated by higher values)
1 study (Scheinberg 2006)15g15h-0.2 loweriModerate
Mean GAS T-score at week12 of treatment (better indicated by higher values)
1 study (Scheinberg 2006)15j15k-6.6 higherlModerate
Gait assessment performance improved (interstep distance and angle of the foot to the direction of walking)m
1 study (McKinlay 1980)8/204/20RR = 2.00 (0.72 to 5.59)*n20 more per 100 (from 6 fewer to 92 more)*Low

CI confidence interval, GAS T-score Goal Attainment Scaling T-score, PEDI Pediatric Evaluation of Disability Inventory

*

Calculated by the NCC-WCH

a

Baseline mean PEDI self care score: 15.2 (6.5 to 23.8). Final score 19.1 (8.8 to 29.4)

b

Baseline mean PEDI self care score: 15.2 (6.5 to 23.8). Final score 20.5 (9.8 to 31.3)

c

Reported in paper as mean change = -1.5 (-3.5 to 0.6). No significant treatment, carry over or period effects found

d

Baseline mean PEDI mobility score: 17.5 (7.3 to 27.8). Final score 17.3 (6.9 to 27.7)

e

Baseline mean PEDI mobility score: 17.5 (7.3 to 27.8). Final score 18.7 (8.1 to 29.4)

f

Reported in paper as mean change = -1.5 (-3.1 to 0.2). No significant treatment, carry over or period effects found

g

Baseline mean PEDI social function score: 31.8 (18.0 to 45.6). Final score 32.7 (19.8 to 45.6)

h

Baseline mean PEDI social function score: 31.8 (18.0 to 45.6). Final score 32.9 (19.3 to 46.5)

i

Reported in paper as mean change = -0.2 (-3.0 to 2.6) No significant treatment, carry over or period effects found

j

Baseline mean GAS T-score was set at 35.0. Final score 51.3 (47.4 to 55.1)

k

Baseline mean GAS T-score was set at 35.0. Final score 44.7 (39.3 to 50.0)

l

Reported in paper as mean change = 6.6 (1.0 higher to 12.3).

m

Physiotherapy staff asked children to walk along a roll of wallpaper on the floor after standing in black paint

n

The investigators report that performance was unchanged throughout for 8/20 children

See the complete GRADE Table K.6.5 which accompanies this abbreviated version.

Calculated by the NCC-WCH

Baseline mean PEDI self care score: 15.2 (6.5 to 23.8). Final score 19.1 (8.8 to 29.4)

Baseline mean PEDI self care score: 15.2 (6.5 to 23.8). Final score 20.5 (9.8 to 31.3)

Reported in paper as mean change = -1.5 (-3.5 to 0.6). No significant treatment, carry over or period effects found

Baseline mean PEDI mobility score: 17.5 (7.3 to 27.8). Final score 17.3 (6.9 to 27.7)

Baseline mean PEDI mobility score: 17.5 (7.3 to 27.8). Final score 18.7 (8.1 to 29.4)

Reported in paper as mean change = -1.5 (-3.1 to 0.2). No significant treatment, carry over or period effects found

Baseline mean PEDI social function score: 31.8 (18.0 to 45.6). Final score 32.7 (19.8 to 45.6)

Baseline mean PEDI social function score: 31.8 (18.0 to 45.6). Final score 32.9 (19.3 to 46.5)

Reported in paper as mean change = -0.2 (-3.0 to 2.6) No significant treatment, carry over or period effects found

Baseline mean GAS T-score was set at 35.0. Final score 51.3 (47.4 to 55.1)

Baseline mean GAS T-score was set at 35.0. Final score 44.7 (39.3 to 50.0)

Reported in paper as mean change = 6.6 (1.0 higher to 12.3).

Physiotherapy staff asked children to walk along a roll of wallpaper on the floor after standing in black paint

The investigators report that performance was unchanged throughout for 8/20 children

From: 6, Oral drugs

Cover of Spasticity in Children and Young People with Non-Progressive Brain Disorders
Spasticity in Children and Young People with Non-Progressive Brain Disorders: Management of Spasticity and Co-Existing Motor Disorders and Their Early Musculoskeletal Complications.
NICE Clinical Guidelines, No. 145.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2012 Jul.
Copyright © 2012, National Collaborating Centre for Women's and Children's Health.

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