Table 1 Baseline characteristics of the study subjects
Variable | Study group | P value | |
|---|---|---|---|
Hyal-Joint® (n = 11) | Placebo (n = 9) | ||
Men/women | 4/7 | 5/4 | 0.653 |
Age, years, mean (SD) | 57.7 (10.1) | 54.6 (7.7) | 0.448 |
Ethnicity | 0.361 | ||
Black | 0 | 1 | |
Caucasian | 1 | 1 | |
Hispanic | 10 | 6 | |
Height, cm, mean (SD) | 164.7 (6.1) | 164.1 (10.8) | 0.889 |
Weight, kg, mean (SD | 79.1 (26.3) | 80.9 (20.7) | 0.867 |
Heart rate, beats/min, mean (SD) | 75.5 (12.3) | 75.7 (12.4) | 0.970 |
Systolic BP, mm Hg, mean (SD) | 122.8 (16.4) | 135.6 (21.7) | 0.152 |
Diastolic BP, mm Hg, mean (SD) | 77.8 (8.9) | 84.3 (10.4) | 0.148 |
Rescue medication use (paracetamol 500 mg)* | |||
No. capsules (range) | 4 (0–19) | 9 (0–29) | 0.425 |
Mean (SD) | 6.8 (7.3) | 9.9 (9.6) | |
WOMAC scores, mean (SD) | |||
Pain | 10.4 (3.0) | 10.1 (2.7) | 0.848 |
Stiffness | 4.4 (1.0) | 4.4 (1.0) | 0.862 |
Physical function | 37.7 (7.4) | 35.4 (11.5) | 0.597 |
Aggregated total symptoms | 52.5 (10.8) | 50.0 (14.4) | 0.667 |
SF-36v2 scores, mean (SD) | |||
Physical functioning | 30.8 (8.5) | 27.1 (8.5) | 0.342 |
Role-physical | 35.3 (8.3) | 41.9 (7.8) | 0.084 |
Bodily pain | 33.2 (4.8) | 36.9 (4.8) | 0.100 |
General health | 44.1 (12.3) | 45.4 (10.3) | 0.814 |
Vitality | 49.0 (11.3) | 50.4 (11.7) | 0.791 |
Social functioning | 37.5 (12.0) | 43.5 (11.3) | 0.268 |
Role-emotional | 36.1 (12.6) | 40.3 (12.9) | 0.467 |
Mental health | 40.3 (19.7) | 47.5 (9.5) | 0.326 |
Physical component summary (PCS-36) | 34.8 (6.3) | 34.6 (6.4) | 0.947 |
Mental component summary (MCS-36) | 43.6 (17.5) | 50.6 (11.2) | 0.317 |