Instrument | Assessment | Time of assessment |
---|---|---|
Sampling form | Inclusion/exclusion criteria | Before randomization |
Sociodemographic data form | Sociodemographic data (age, sex, BMI) | Baseline |
Baseline clinical data form | Medical history, concomitant medications, and analgesic drugs to control HZ-related pain | Baseline, 1, 4, 6, and 12 weeks |
Visual analogue scale pain score | Severity of pain before/after therapy | Baseline, 4, 6, and 12 weeks |
SF-12 questionnaire | Health-related quality of life | Baseline and 12 weeks |
Monitor adherence | Indirect method: patient questionnaires, patient self-reports, and pill counts | 12 weeks |
Adverse events | Adverse event evaluations related to study medication | 1, 4, 6, and 12 weeks |
MOS Sleep Scale | Extent of sleep problems (sleep initiation, maintenance, respiratory problems, quantity, perceived adequacy, and somnolence) | Baseline and 12 weeks |
DN4 | Neuropathic pain consisting of interview questions and physical tests | Baseline and 12 weeks |
Analgesic consumption form | Total consumption of analgesic drugs during the study period | 12 weeks |
Number of patients on analgesics at the end of the study |