Table 2.
Outcomes | Groups | Baseline | Week 6 | Week 12 | Week 24 | p-value intergroup* |
---|---|---|---|---|---|---|
VAS 0-10 cm for overall pain, mean (SD) | PRP | 6.1 (1.6) | 3.7 (2.4) | 2.0 (1.4) | 3.2 (2.5) | 0.483 |
Plasma | 5.9 (1.4) | 3.7 (2.5) | 3.2 (2.8) | 3.5 (2.4) | ||
Placebo | 6.6 (1.4) | 3.5 (2.1) | 3.9 (2.7) | 3.1 (2.6) | ||
VAS for overall pain (change from baseline), mean (SD) | PRP | - | -2.4 (2.7) | -4.1 (1.6) | -2.9 (2.5) | 0.499 |
Plasma | - | -2.2 (2.3) | -2.7 (3.0) | -2.4 (2.5) | ||
Placebo | - | -3.1 (2.5) | -2.7 (3.2) | -3.5 (3.3) | ||
VAS for overall pain, % of improvement, mean (SD) | PRP | - | -36.5 (39.7) | -67.0 (23.0) | -46.4 (41.3) | nsa |
Plasma | - | -36.2 (39.8) | -43.5 (55.6) | -38.0 (50.4) | ||
Placebo | - | -43.4 (46.5) | -35.8 (52.5) | -46.5 (54.3) | ||
VAS 0-10 cm for pain at rest, mean (SD) | PRP | 2.5 (2.3) | 1.2 (1.6) | 0.6 (0.8) | 1.6 (2.2) | 0.216 |
Plasma | 1.5 (1.9) | 0.8 (1.1) | 0.6 (0.7) | 0.9 (0.9) | ||
Placebo | 1.9 (1.9) | 1.6 (2.0) | 1.0 (1.2) | 1.4 (2.3) | ||
VAS 0-10 cm for pain at movement, mean (SD) | PRP | 6.8 (2.1) | 4.7 (2.8) | 3.7 (2.3) | 3.7 (2.8) | 0.928 |
Plasma | 6.8 (2.1) | 4.5 (3.1) | 3.9 (3.1) | 4.0 (2.7) | ||
Placebo | 6.8 (2.0) | 4.2 (2.2) | 3.9 (2.9) | 3.5 (2.6) | ||
PhGA 0-10 cm, mean (SD) | PRP | 4.6 (1.9) | 3.3 (2.0) | 2.3 (1.4) | 3.0 (2.0) | 0.634 |
Plasma | 4.6 (1.5) | 3.1 (2.0) | 2.9 (2.1) | 3.1 (1.8) | ||
Placebo | 4.1 (1.7) | 2.7 (1.8) | 2.5 (1.5) | 2.7 (2.0) | ||
PGA (0-100%), mean (SD) | PRP | - | 48.0 (29.9) | 67.3 (21.6) | 56.3 (29.2) | 0.639 |
Plasma | - | 59.0 (25.3) | 63.2 (24.5) | 67.7 (18.8) | ||
Placebo | - | 59.0 (27.0) | 57.7 (31.1) | 66.7 (25.4) | ||
Likert for global improvementb, % | PRP | - | 0 – 10% | 0 – 0% | 0 – 5% | nsc |
1 – 15% | 1 – 5% | 1 – 20% | ||||
2 – 25% | 2 – 20% | 2 – 15% | ||||
3 – 45% | 3 – 60% | 3 – 35% | ||||
4 – 5% | 4 – 15% | 4 – 25% | ||||
Plasma | - | 0 – 5% | 0 – 0% | 0 – 0% | ||
1 – 10% | 1 – 15% | 1 – 5% | ||||
2 – 35% | 2 – 20% | 2 – 40% | ||||
3 – 45% | 3 – 50% | 3 – 35% | ||||
4 – 5% | 4 – 15% | 4 – 20% | ||||
Placebo | - | 0 – 10% | 0 – 14% | 0 – 5% | ||
1 – 10% | 1 – 10% | 1 – 14% | ||||
2 – 33% | 2 – 19% | 2 – 5% | ||||
3 – 38% | 3 – 48% | 3 – 67% | ||||
4 – 10% | 4 – 10% | 4 – 10% | ||||
WOMAC Pain 0-20, mean (SD) | PRP | 10.7 (3.2) | 7.9 (3.7) | 5.6 (2.6) | 6.6 (3.5) | 0.561 |
Plasma | 9.2 (2.5) | 6.8 (3.6) | 6.1 (3.9) | 6.5 (3.6) | ||
Placebo | 11.0 (3.1) | 7.4 (3.5) | 7.1 (2.8) | 6.2 (2.3) | ||
WOMAC stiffness 0-8, mean (SD) | PRP | 4.4 (1.7) | 2.8 (1.7) | 2.1 (1.0) | 2.7 (1.6) | 0.713 |
Plasma | 4.0 (1.4) | 2.9 (1.7) | 2.6 (1.9) | 2.5 (1.7) | ||
Placebo | 4.3 (1.8) | 2.8 (1.6) | 3.0 (1.5) | 2.8 (1.5) | ||
WOMAC function 0-68, mean (SD) | PRP | 37.9 (11.6) | 25.8 (12.0) | 21.2 (9.8) | 23.5 (14.3) | 0.847 |
Plasma | 33.5 (11.2) | 25.4 (13.9) | 20.9 (14.6) | 24.2 (15.5) | ||
Placebo | 37.0 (12.0) | 26.6 (12.5) | 24.7 (10.0) | 22.6 (11.0) | ||
WOMAC Total 0-96, mean (SD) | PRP | 52.9 (15.5) | 36.4 (16.7) | 28.9 (12.6) | 32.7 (18.9) | 0.787 |
Plasma | 46.7 (14.3) | 35.0 (18.5) | 29.6 (19.9) | 33.2 (20.3) | ||
Placebo | 52.3 (15.9) | 36.9 (17.1) | 34.9 (13.5) | 31.6 (14.4) | ||
KOOS Symptoms 0-100, mean (SD) | PRP | 46.1 (21.0) | 67.0 (19.0) | 71.4 (13.2) | 63.9 (21.2) | 0.442 |
Plasma | 56.1 (21.6) | 66.3 (18.1) | 69.4 (20.0) | 66.0 (23.6) | ||
Placebo | 45.4 (15.9) | 63.6 (15.8) | 59.9 (17.1) | 65.3 (17.4) | ||
KOOS Pain 0-100, mean (SD) | PRP | 42.9 (15.3) | 63.9 (18.7) | 67.6 (12.5) | 62.4 (20.1) | 0.434 |
Plasma | 40.8 (17.5) | 61.9 (19.3) | 67.5 (21.9) | 66.1 (21.0) | ||
Placebo | 40.7 (14.6) | 58.7 (13.9) | 59.4 (16.2) | 66.1 (16.7) | ||
KOOS ADL 0-100, mean (SD) | PRP | 44.4 (15.3) | 64.3 (18.3) | 68.3 (17.0) | 64.0 (20.7) | 0.607 |
Plasma | 51.8 (18.6) | 65.9 (19.0) | 70.4 (21.8) | 67.7 (19.7) | ||
Placebo | 45.4 (16.2) | 62.0 (16.0) | 63.3 (15.4) | 68.6 (16.7) | ||
KOOS Sport/Recreation 0-100, mean (SD) | PRP | 12.8 (10.9) | 27.8 (19.0) | 35.5 (21.0) | 32.8 (21.1) | 0.031d |
Plasma | 29.8 (21.0) | 38.8 (27.8) | 51.7 (30.3) | 46.0 (25.2) | ||
Placebo | 17.4 (12.2) | 33.8 (20.7) | 35.7 (16.4) | 40.7 (21.6) | ||
KOOS QOL 0-100, mean (SD) | PRP | 18.1 (13.9) | 33.1 (21.4) | 48.1 (22.0) | 39.1 (22.4) | 0.336 |
Plasma | 29.5 (16.4) | 42.3 (25.4) | 51.5 (27.5) | 45.2 (22.7) | ||
Placebo | 25.0 (15.3) | 39.0 (20.2) | 43.2 (16.9) | 50.6 (22.7) | ||
OMERACT-OARSI Criteria, % | PRP | - | 75% | 95% | 80% | nse |
Plasma | - | 70% | 85% | 80% | ||
Placebo | - | 81% | 76% | 86% | ||
TUGT (s), mean (SD) | PRP | 13.6 (2.8) | 13.0 (3.2) | 11.6 (1.6) | 11.5 (1.3) | 0.866 |
Plasma | 13.8 (3.1) | 12.1 (2.7) | 12.2 (3.0) | 12.2 (3.0) | ||
Placebo | 13.6 (3.0) | 12.3 (2.7) | 11.4 (2.0) | 11.4 (2.4) |
* This p-value represents difference between groups; there was a statistically significant difference intragroup for all baseline parameters in relation to 6, 12 and 24 weeks
a P-value intergroup week 6: p = 0.823; week 12: p = 0.162; week 24: p = 0.814
b 0 - no improvement; 1 - mild improvement; 2 - moderate improvement; 3 - good improvement; 4 - excellent improvement
c P-value intergroup week 6: p = 0.986; week 12: p = 0.712; week 24: p = 0.076. There was a significant difference in the PRP group between weeks 6 and 12 (p = 0.003) suggesting better responses in week 12
d The difference occurred due to difference between groups PRP and plasma (p = 0.03) from week 6 to week 12 (p = 0.005)
e P-value intergroup week 6: p = 0.767; week 12: p = 0.268; week 24: p = 0.872
Abbreviations: VAS visual analogue scale 0-10 cm, SD standard deviation; ns: no statistical significance, PhGA physician global assessment 0-10 cm, PGA participant’s global assessment for improvement, WOMAC Western Ontario McMaster Universities Osteoarthritis Index, KOOS Knee Injury and Osteoarthritis Outcome Score, ADL function in daily living, QOL quality of life, TUGT timed up and go test