Table 2.
‘Nocturnal cramps’ (from NADCS) | ‘Painful muscle cramps or spasms due to PD’ (PDQ-8 item 7) | ‘Pain in arms or legs’ (PDSS-2 item 10) | ‘Muscle cramps in arms or legs’ (PDSS-2 item 11) | ‘Painful posturing in the morning’ (PDSS-2 item 12) | ‘Suffer from pain not explained by other known conditions’ (NMSS item 29) | |
---|---|---|---|---|---|---|
‘No’ pain (n = 80) (pain score 0) |
0.4 ± 0.8 |
0.8 ± 0.9 |
0.5 ± 0.9 |
0.6 ± 1.0 |
0.5 ± 0.9 |
0.6 ± 1.8 |
‘Mild’ pain (n = 87) (pain score 1–3) |
0.7 ± 0.9 (p = 0.020) |
1.3 ± 1.0 (p < 0.001) |
1.1 ± 1.1 (p <0.001) |
1.0 ± 1.1 (p = 0.007) |
0.7 ± 1.0 (p = 0.139) |
1.1 ± 2.1 (p = 0.062) |
‘Moderate-to-severe’ pain (n = 100) (pain score ≥4) | 1.1 ± 1.1 (p <0.0001) | 1.7 ± 1.0 (p <0.0001) | 1.9 ± 1.2 (p <0.0001) | 1.5 ± 1.2 (p <0.0001) | 1.4 ± 1.2 (p <0.0001) | 2.1 ± 3.4 (p <0.001) |
Data are mean ± SD. Data are presented for the FAS.
P values (t-test exploratory analyses) are reported for patients with ‘Mild’ pain and patients with ‘Moderate-to-severe’ pain vs patients with ‘No’ pain at baseline (assessed by the Likert pain scale).
FAS: full analysis set; NADSC: Nocturnal Akinesia, Dystonia and Cramps total score; NMSS: Non-Motor Symptoms Scale; PD: Parkinson’s disease; PDQ-8: 8-item Parkinson’s Disease Questionnaire; PDSS-2: Parkinson’s Disease Sleep Scale; RECOVER: Randomized Evaluation of the 24-hour Coverage: Efficacy of Rotigotine; SD: standard deviation.