Background
Objective
Research question
Methods
Study design
Participants
Randomisation
Interventions
Outcome assessment
T0 1 WEEK PRIOR TO SURGERY | T1 END OF CLINICAL PHASE | T2 17 DAYS AFTER SURGERY | T3 6 WEEKS AFTER SURGERY | T4 12 WEEKS AFTER SURGERY | |
---|---|---|---|---|---|
Range of motion | X | X | X | X | X |
Knee Society Score | X | X | X | X | X |
WOMAC | X | X | X | X | |
Perceived effect | X | X | X | ||
Pain medication | X | X | X | X | |
Satisfaction with treatment | X | X | X | ||
Satisfaction with results | X | X | X | ||
Adherence | X | ||||
Quantity, duration and kind of treatment | X | X | X |
Power analyses
Data analysis
Results
T0 | PT + CPM N = 30 | PT N = 30 | ||
---|---|---|---|---|
Gender % female | 60 | 70 | ||
Mean | Sd | Mean | Sd | |
Age | 64.1 | 8.1 | 65 | 9.1 |
Active RoM before surgery (flexion to extension) | 104.9 | 13.8 | 100.7 | 13.2 |
Passive RoM before surgery | 110.2 | 14.0 | 105.9 | 13.8 |
Active extension | 4.8 | 4.6 | 6.2 | 5.0 |
Active flexion | 109.7 | 12.1 | 106.9 | 12.3 |
Passive extension | 3.3 | 4.3 | 4.7 | 4.3 |
Passive flexion | 113.5 | 12.4 | 110.6 | 11.8 |
KSS knee | 53.5 | 16.4 | 47.5 | 15.3 |
KSS function | 61.5 | 10.6 | 52.3 | 18.7 |
WOMAC score | 54.8 | 17.7 | 51.2 | 13.6 |
Pain subscale | 10.6 | 4.7 | 10.5 | 3.1 |
Stiffness subscale | 4. 0 | 1.9 | 3.8 | 2.1 |
Difficulty subscale | 40. 2 | 13.2 | 36.9 | 11.7 |
T1 | PT + CPM N = 30 | PT N = 30 | ||
---|---|---|---|---|
Active RoM at T1 | 66.1 | 8.9 | 66.6 | 6.8 |
Passive RoM at T1 | 71.1 | 8.4 | 72.5 | 5.7 |
Active extension | 8.9 | 4.4 | 8.1 | 4.4 |
Active flexion | 75 | 6.9 | 74.7 | 4.5 |
Passive extension | 6.7 | 4.1 | 6.1 | 4.2 |
Passive flexion | 77.8 | 7.1 | 78.6 | 3.8 |
Knee society knee score at T1 | 55.9 | 17 | 50.0 | 17.6 |
Knee society function score at T1 | 25.8 | 14 | 26 | 13.5 |
Primary outcome measures
Range of motion
T2 ROM | PT + CPM N = 30 | PT N = 30 | P VALUE | 95% CI | ||
---|---|---|---|---|---|---|
Mean | sd | Mean | sd | |||
Active RoM at T2 | 83.6 | 11.4 | 78.6 | 8.7 | 0.06 | -0.2 – 10.3 |
Passive RoM at T2 | 88.7 | 10.4 | 84.0 | 9.9 | 0.07 | -0.5 – 10.0 |
Delta active RoM T1-T2 | 17.5 | 13.4 | 11.9 | 9.8 | 0.07 | -0.5 – 11.6 |
Delta passive RoM T1-T2 | 17.6 | 12.9 | 11.6 | 9.4 | 0.04 | 0.02 – 11.9 |
Extension active | 6.3 | 3.9 | 8.1 | 4.8 | 0.11 | -4.1 – 0.4 |
Extension passive | 4.3 | 3.1 | 5.7 | 4.6 | 0.17 | -3.4 – 0.6 |
Flexion active | 89.9 | 9.1 | 86.7 | 8.5 | 0.16 | -1.4 – 7.8 |
Flexion passive | 93 | 8.8 | 89.7 | 9.6 | 0.17 | -1.4 – 8.1 |
KSS knee score | 67.6 | 19.6 | 67.3 | 14.9 | 0.94 | -8.7 – 9.3 |
KSS function score | 43 | 14.6 | 39.8 | 21.1 | 0.50 | -4.7 – 11.3 |
WOMAC score | 69.9 | 15.9 | 65.4 | 16.4 | 0.28 | -3.9 – 12.9 |
WOMAC pain | 15.8 | 4.7 | 15.3 | 4.1 | 0.60 | -2.9 – 1.7 |
WOMAC stiffness | 5.0 | 1.8 | 4.8 | 1.6 | 0.66 | -0.7 – 1.1 |
WOMAC difficulty | 49.1 | 11.9 | 45.3 | 12.3 | 0.23 | -2.5 – 10.1 |
T2 17 DAYS AFTER SURGERY | T3 6 WEEKS AFTER SURGERY | |||||||
---|---|---|---|---|---|---|---|---|
Group | < 95° > | < 105° > | < 95° > | < 105° > | ||||
CPM + PT | 25 | 5 | 27 | 3 | 10 | 20 | 20 | 10 |
PT | 24 | 6 | 28 | 2 | 10 | 20 | 22 | 8 |
Functional status
6 WEEKS | 3 MONTHS | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
PT+CPM n = 30 | Pt n = 30 | P value | 95ci | PT+CPM n = 30 | Pt n = 30 | P value | 95ci | |||||
Mean | sd | Mean | sd | Mean | sd | Mean | sd | |||||
Active RoM | 91.9 | 13.6 | 91.8 | 14.3 | 0.98 | -7. – 7.3 | 100.9 | 4.8 | 102 | 4.3 | 0.78 | -8.8 – 6.6 |
Passive RoM | 96.9 | 13.4 | 95.5 | 14.2 | 0.69 | -5. – 8.5 | 106.1 | 14.1 | 106.2 | 3.7 | 0.98 | -7.5 – 7.3 |
Extension active | 6.3 | 4.0 | 6.9 | 5.4 | 0.63 | -3.0 – 1.8 | 4.8 | 3.9 | 4.3 | 4.7 | 0.61 | -1.7 – 2.9 |
Flexion active | 98.2 | 11.7 | 98.7 | 11.2 | 0.87 | -6. – 5.4 | 105.7 | 2.5 | 106.2 | 0.6 | 0.99 | -6.7 – 5.6 |
KSS knee score | 77.3 | 14.9 | 73.6 | 13.8 | 0.33 | -3.8 -11.1 | 80.4 | 5.3 | 78.8 | 9.2 | 0.72 | -7.6 – 10.8 |
KSS function score | 59.8 | 10.0 | 56.2 | 15.8 | 0.29 | -3.2 – 0.5 | 72.4 | 11.4 | 65.5 | 2.1 | 0.15 | -2.6 – 16.3 |
WOMAC score | 75 | 13.6 | 74.5 | 16.1 | 0.89 | -7.2 – 8.2 | 80.5 | 7.7 | 82.8 | 0.5 | 0.56 | -10.5 – 5.5 |
WOMAC pain | 16.0 | 3.7 | 16.6 | 4.0 | 0.53 | -2.6 – 1.4 | 17.3 | 3.8 | 17.5 | .9 | 0.83 | -2.3 – 1.8 |
WOMAC stiffness | 5.4 | 1.5 | 4.8 | 1.5 | 0.13 | -0.2 – 1.4 | 5.5 | 1.4 | 5.3 | 1.6 | 0.49 | -0.5 – 1.0 |
WOMAC difficulty | 53.0 | 9.5 | 52.7 | 12.0 | 0.92 | -5.3 – 5.9 | 57.6 | 4.2 | 58.6 | 8.4 | 0.74 | -7.3 – 5.2 |
Perceived effect | 2.3 | 0.76 | 2.4 | 0.85 | 0.87 | -0.45 -.38 | 2.1 | 0.7 | 2.4 | 1.0 | 0.16 | -0.73 – 0.14 |
Satisfaction with treatment | 8.3 | 0.88 | 8.7 | 0.84 | 0.76 | -0.85 -0.1 | 8.6 | 0.77 | 8.5 | 0.88 | 0.70 | -0.35 – 0.52 |
Satisfaction with results | 8.1 | 1.0 | 8.4 | 1.0 | 0.21 | -0.85 -.18 | 8.6 | 0.8 | 8.2 | 1.5 | 0.20 | -0.22 – 1.0 |
Secondary outcome
T2 ROM | PT + CPM N = 30 | PT N = 30 | P value | 95% CI | ||
---|---|---|---|---|---|---|
MEAN | SD | MEAN | SD | |||
Number of treatment sessions | 4.8 | 1.5 | 5.1 | 1.4 | 0.43 | -1.05 – 0.44 |
Duration per session | 29.5 | 5.5 | 28.4 | 5.9 | 0.49 | -2.0 – 4.13 |
Perceived effect | 3.2 | 1.5 | 3.0 | 1.5 | 0.55 | -0.5 – 1.0 |
Satisfaction with treatment | 8.2 | 0.8 | 8.5 | 0.7 | 0.37 | -1.0 – -0.1 |
Satisfaction with results | 7.4 | 1.4 | 7.8 | 1.5 | 0.35 | -1.2 – 0.3 |
Adherence | 97% | 100% |