Figure for a parallel design with 2 groups
Figure 1. Design and flow of participants through the trial.
Figure for a crossover design with 2 groups each receiving 2 interventions in different order:
Figure 1. Design and flow of participants through the trial.
Table 1
Baseline characteristics of participants, therapists and centres.
Characteristic / Randomised(n = 110) / Lost to follow-up
(n = 11)
Exp
(n = x) / Con
(n = x) / Exp
(n = x) / Con
(n = x)
Participants
Age (yr), mean (SD) / x (x) / x (x) / x (x) / x (x)
Gender, n males (%) / x (x) / x (x) / x (x) / x (x)
Occupation category, n (%)
Sedentary / x (x) / x (x) / x (x) / x (x)
Light / x (x) / x (x) / x (x) / x (x)
Medium / x (x) / x (x) / x (x) / x (x)
Heavy / x (x) / x (x) / x (x) / x (x)
Very heavy / x (x) / x (x) / x (x) / x (x)
Other / x (x) / x (x) / x (x) / x (x)
Pre-morbid ambulatory status, n (%)
Walk unaided / x (x) / x (x) / x (x) / x (x)
Walk with stick / x (x) / x (x) / x (x) / x (x)
Triage category, n (%)
Urgent (Category 3) / x (x) / x (x) / x (x) / x (x)
Semi-urgent (Category 4) / x (x) / x (x) / x (x) / x (x)
Non-urgent (Category 5) / x (x) / x (x) / x (x) / x (x)
Pain referred to the leg, n (%) / x (x) / x (x) / x (x) / x (x)
Work-related injuries, n (%) / x (x) / x (x) / x (x) / x (x)
Medication (Intramuscular), n (%) / x (x) / x (x) / x (x) / x (x)
Therapists
Participants treated, n (%)
1 / x (x) / x (x) / x (x) / x (x)
2 / x (x) / x (x) / x (x) / x (x)
3 / x (x) / x (x) / x (x) / x (x)
4 / x (x) / x (x) / x (x) / x (x)
Centres
Participants treated, n (%)
1 / x (x) / x (x) / x (x) / x (x)
2 / x (x) / x (x) / x (x) / x (x)
3 / x (x) / x (x) / x (x) / x (x)
4 / x (x) / x (x) / x (x) / x (x)
Exp = experimental group, Con = control group,
Interval data for a parallel-group design with two groups and one follow-up
Table 2
Mean (SD) of groups, mean (SD) difference within groups, and mean (95%CI) difference between groups.
Outcome / Groups / Difference within groups / Difference between groupsWeek 0
/ Week 6 / Week 6 minus Week 0 / Week 6 minus Week 0Exp
(n = x) / Con
(n = x) / Exp
(n = x) / Con
(n = x) / Exp / Con / Exp minus Con
Subluxation
Vertical distance
(mm) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x to x)
Contracture
Passive ER
(deg) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x.x
(x to x)
Exp = experimental group, Con = control group,
Interval data for a parallel-group design with three groups and one follow-up
Table 2
Mean (SD) of groups, mean (SD) difference within groups, and mean (95% CI) difference between groups.
Outcome / Groups / Difference within groups / Difference between groupsWeek 0
/ Week 6 / Week 6 minus Week 0 / Week 6 minus Week 0Exp 1
(n = x) / Exp 2
(n = x) / Con
(n = x) / Exp 1
(n = x) / Exp 2
(n = x) / Con
(n = x) / Exp 1 / Exp 2 / Con / Exp 1 minus Con / Exp 2 minus Con / Exp 1 minus Exp 2
Subluxation
Vertical distance
(mm) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x to x) / x
(x to x) / x
(x to x)
Contracture
Passive ER
(deg) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x to x) / x
(x to x) / x
(x to x)
Exp = experimental group, Con = control group,
Interval data for a parallel-group design with two follow-ups
Table 2
Mean (SD) of groups, mean (SD) difference within groups, and mean (95% CI) difference between groups.
Outcome / Groups / Difference within groups / Difference between groupsWeek 0
/ Week 6 / Week 14 / Week 6 minus Week 0 / Week 14 minus Week 0 / Week 6 minus Week 0 / Week 14 minus Week 0Exp
(n = x) / Con
(n = x) / Exp
(n = x) / Con
(n = x) / Exp
(n = x) / Con
(n = x) / Exp / Con / Exp / Con / Exp-Con / Exp-Con
Standing
Functional Reach (cm) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x to x) / x
(x to x)
Walking
MAS Item 5
(0 to 6) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x to x) / x
(x to x)
Quality of life
SA-SIP30
(0 to 30) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x to x) / x
(x to x)
Exp = experimental group, Con = control group,
Interval data for a parallel-group design with three groups and two follow-ups
Table 2
Mean (SD) of each group, mean (SD) difference within each group, and mean (95% CI) difference between groups.
Outcome / Groups / Difference within groups / Difference between groupsWeek 0 / Week 6 / Week 12 / Week 6 minus Week 0 / Week 12 minus
Week 0 / Week 6 minus Week 0 / Week 12 minus Week 0
Exp 1
(n = x) / Exp 2
(n = x) / Con
(n = x) / Exp 1
(n = x) / Exp 2
(n = x) / Con
(n = x) / Exp 1
(n = x) / Exp 2
(n = x) / Con
(n = x) / Exp 1
(n = x) / Exp 2
(n = x) / Con
(n = x) / Exp 1
(n = x) / Exp 2
(n = x) / Con
(n = x) / Exp 1 minus Con / Exp 2 minus Con / Exp 1 minus Con / Exp 2 minus Con
Pain severity
VAS (cm) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x to x) / x
(x to x) / x
(x to x) / x
(x to x)
Lumbar ROM
Schober test
(cm) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x to x) / x
(x to x) / x
(x to x) / x
(x to x)
Flexion
(deg) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x to x) / x
(x to x) / x
(x to x) / x
(x to x)
Extension
(deg) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x to x) / x
(x to x) / x
(x to x) / x
(x to x)
R lat flexion
(deg) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x to x) / x
(x to x) / x
(x to x) / x
(x to x)
L lat flexion
(deg) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x to x) / x
(x to x) / x
(x to x) / x
(x to x)
Disability
ODQ
(0 to 50) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x to x) / x
(x to x) / x
(x to x) / x
(x to x)
Exp1 = xxx, Exp2 = xxx, Con = control group,
Interval data for a cross-over design with one follow-up
Table 2
Mean (SD) of interventions, mean (SD) difference within interventions, and mean (95% CI) difference between interventions.
Outcome / Interventions / Difference within interventions / Difference between interventionsPre-test
/ Post-test / Post-test minus Pre-test / Post-test minus Pre-testExp
(n = x) / Con
(n = x) / Exp
(n = x) / Con
(n = x) / Exp / Con / Exp minus Con
Subluxation
Vertical distance
(mm) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x to x)
Contracture
Passive ER
(deg) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x to x)
Exp = experimental intervention, Con = control intervention,
Interval data for a cross-over design with two follow-ups
Table 2
Mean (SD) of interventions, mean (SD) difference within interventions, and mean (95% CI) difference between interventions.
Outcome / Intervention / Difference within interventions / Difference between interventionsPre-test
/ Post-test 1(30 min) / Post-test 2
(60 min) / Post-test 1 minus Pre-test / Post-test 2 minus Pre-test / Post-test 1 minus Pre-test / Post-test 2 minus Pre-test
Exp
(n = x) / Con
(n = x) / Exp
(n = x) / Con
(n = x) / Exp
(n = x) / Con
(n = x) / Exp / Con / Exp / Con / Exp minus Con / Exp minus Con
Gas exchange
PaCO2
(mmHg) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x to x) / x
(x to x)
Ventilation
Lung compliance
(ml/cmH2O) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x) / x
(x to x) / x
(x to x)
Exp = experimental intervention, Con = control intervention,
Categorical or frequency data for a parallel-group design with two groups
Table 3
Number of participants (%) in each group and risk difference (95 % CI) between groups.
Outcome / Groups / Risk difference betweengroupsExp
(n = x) / Con
(n = x) / Exp relative to Con
Discharged home / x
(x) / x
(x) / x
(x to x)
Sustained adverse events / x
(x) / x
(x) / x
(x to x)
Required follow-up physiotherapy intervention / x
(x) / x
(x) / x
(x to x)