Chronic neuropathic pain
Conditions
Brief summary
• Pain severity NRS (measured daily), weekly average, • Experience sampling method (ESM) NRS pain scores
Detailed description
• Sleep quality (Pittsburgh Sleep Quality Index, or PSQI), • Sleep quality (Daily VAS), • Anxiety severity (HADS), • Depression severity (HADS), • Quality of Life questionnaire (SF36), • Drug effects questionnaire (DEQ), including VAS ‘Feeling high’ ‘Drug liking’ and VAS ‘Want more of the drug’, • Trial At Home (T@H) geospatial and phone usage tracking, • Treatment-emergent (serious) adverse events ((S)AEs) throughout the study at every study visit, • Concomitant medication throughout the study at every study visit, • Vital signs (Pulse Rate (bpm), Systolic blood pressure (mmHg), Diastolic blood pressure (mmHg)) as per assessment schedule, • Pain severity NRS (measured daily), weekly average
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Pain severity NRS (measured daily), weekly average, • Experience sampling method (ESM) NRS pain scores | — |
Secondary
| Measure | Time frame |
|---|---|
| • Sleep quality (Pittsburgh Sleep Quality Index, or PSQI), • Sleep quality (Daily VAS), • Anxiety severity (HADS), • Depression severity (HADS), • Quality of Life questionnaire (SF36), • Drug effects questionnaire (DEQ), including VAS ‘Feeling high’ ‘Drug liking’ and VAS ‘Want more of the drug’, • Trial At Home (T@H) geospatial and phone usage tracking, • Treatment-emergent (serious) adverse events ((S)AEs) throughout the study at every study visit, • Concomitant medication throughout the study at every study visit, • Vital signs (Pulse Rate (bpm), Systolic blood pressure (mmHg), Diastolic blood pressure (mmHg)) as per assessment schedule, • Pain severity NRS (measured daily), weekly average | — |
Countries
Netherlands