Background
Methods
Design
Registration
Setting
Participants
Interview and examination
Measurements
Interventions
Outcomes
Sample size
Randomization
Sequence generation
Control of bias
Statistical analysis
Results
Participant flow
Recruitment
Baseline data
Variables | Group 1 (n = 15) | Group 2 (n = 15) |
p
|
---|---|---|---|
Age, y [mean ± sd] | 38.5 ± 2.8 | 36.8 ± 3.2 | .132 |
BMI, Kg.m−2 [mean ± sd] | 28.8 ± 4.1 | 25.0 ± 3.8 | .129 |
Parity [median, range] | 1 (0–6) | 1 (0–3) | .700 |
Abdominal surgeries [median, range] | 1 (0–4) | 1 (0–3) | 820 |
Measures pretreatment | |||
VAS, mm [median, interquartile] | 54 (49–90) | 67 (56–75) | .505 |
McGill [median, interquartile] | 29.5 (13–38) | 35.5 (21–42) | .434 |
Time of symptoms [median, interquartile] | 31 (8–76) | 38 (9–63) | .331 |
Pain threshold, kg.cm−2 [mean ± sd] | 1.05 ± 0.49 | 1.04 ± 1.30 | .988 |
Pain tolerance, kg.cm−2 [mean ± sd] | 1.90 ± 0.72 | 1.81 ± 1.62 | .864 |
HAD anxiety [median, interquartile] | 11 (8–16) | 13 (10–17) | .187 |
HAD depression [median, interquartile] | 10.5 (5–14) | 10.5 (8–13) | .853 |
WHOQoL [mean ± sd] | 53.0 ± 10.3 | 49.2 ± 14.2 | .448 |
Numbers analysed
Satisfactory clinical response rate
Time | Group 1 (n = 15) | Group 2 (n = 15) | RR crude (IC 95 %) | RR adjust (IC 95 %)a |
---|---|---|---|---|
1st week | 12 (80,00 %) | 6 (40,00 %) | 2 (1,02; 3,91) | 3,8 (1,17; 8,08) |
4th week | 12 (80,00 %) | 6 (40,00 %) | 2 (1,02; 3,91) | |
12th week | 11 (73,33 %) | 2 (13,33 %) | 5,5 (1,46; 20,71) |
Pain relief
Groups | VAS Baseline % [median(range)] | VAS 1st week % [median(range)] | VAS 4th week % [median(range)] | VAS 12th week % [median(range)] | Pd |
---|---|---|---|---|---|
Group 1 | 0.0 [54 (49–90)] | −45.3a [30.5 (8–58)] | −60.2b [10 (0–49)] | −69.9c [8 (0–39)] | .03 |
Group 2 | 0.0 [67 (56–75)] | −18.7a [50 (47–54)] | −9.2b [60 (42–61)] | −8.5c [56 (42–67)] | .47 |
P | .50 | .08 | <.01 | <.01 | --- |
Groups | Baseline | 1st week | 4th week | 12th week | Pd |
---|---|---|---|---|---|
Threshold | |||||
Group 1 | 1.00 (0.85–1.31) | 0.97a (0.88–1.04) | 1.44b (1.08–1.62) | 1.37c (1.26–1.49) | <.01 |
Group 2 | 0.72 (0.57–1.06) | 1.21 (0.84–1.82) | 1.08 (0.92–1.13) | 1.10 (0.95–1.27) | .76 |
p
| .99 | .32 | .13 | .97 | |
Tolerance | |||||
Group 1 | 1.87 (1.42–2.24) | 1.60a (1.46–1.72) | 2.00b (1.73–2.23) | 2.23c (2.22–2.24) | <.01 |
Group 2 | 1.44 (1.04–1.92) | 1.91 (1.53–2.44) | 1.51 (1.22–1.87) | 1.46 (1.32–1.49) | .52 |
p
| .86 | .67 | .09 | .24 |