The Lequesne questionnaire [11 (link)] was modified to incorporate the patient’s weight and height. The Lequesne score is a standardized questionnaire focused on osteoarthritis. It is a 24-scale questionary in which low scores indicate low functional activity (Table 1 ).
Pre-study calculations revealed that 198 patients for each group were required to arrive at a statistical significance of p < 0.05 and a power of 80% for a difference in one unit in the Lequesne score. Matched pairs were established for potential interference variables such as gender, age, and body mass index. The first evaluations of equivalences were performed stepwise with 100, 200, 300, and 400 patients. Finally, a complete equivalence could not be achieved for gender (55% women in the active treatment group and 45% women in the control group) and body mass index (76.27 ± 9.1 kg in the control group).
The Lequesne score correlates significantly with pain and consists of three subscores which were calculated individually and together: pain and discomfort, maximum distance walked, and activities of daily living with a maximum score of 8 for each subscore and a total score of 24 (see Additional file1 ). A difference in one score unit is regarded as clinically relevant. The groups were evaluated by the Levene test for equality of variance and by the T-test for equality of the mean.
| Adalat® (Nifedipine) | 4.0 | 5 | 3 | 0 |
| Amlodipine® (Amlodipine) | 3.5 | 22 | 2.97 | 0 |
| Azupamil® (Verapamil) | 6 | 8 | 3.59 | 0 |
| Carmen® (Lercanidipine) | 3 | 21 | 2.91 | 0 |
| Escor® (Nilvadipine) | 6 | 5 | 4.72 | 0 |
| Felodipine® (Felodipine) | 5 | 7 | 4.1 | 0 |
| Nifedipine® (Nifedipine) | 6.2 | 15 | 5.21 | 0 |
| Nitrendipine® (Nitrendipin) | 2.1 | 8 | 2.8 | 0 |
| Norvasc® (Amlodipine) | 4.8 | 48 | 5 | 0 |
| Verapamil® (Verapamil) | 6.9 | 49 | 5 | 0 |
| Control group | 6.2 | 212 | 4.85 | 0 |
SD standard deviation.
Pre-study calculations revealed that 198 patients for each group were required to arrive at a statistical significance of p < 0.05 and a power of 80% for a difference in one unit in the Lequesne score. Matched pairs were established for potential interference variables such as gender, age, and body mass index. The first evaluations of equivalences were performed stepwise with 100, 200, 300, and 400 patients. Finally, a complete equivalence could not be achieved for gender (55% women in the active treatment group and 45% women in the control group) and body mass index (76.27 ± 9.1 kg in the control group).
The Lequesne score correlates significantly with pain and consists of three subscores which were calculated individually and together: pain and discomfort, maximum distance walked, and activities of daily living with a maximum score of 8 for each subscore and a total score of 24 (see Additional file
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