M79.70
Conditions
Interventions
Group 1: Prospective, multicenter, non-interventional observational study
Inclusion of at least 100 patients with fibromyalgie syndrome
Data collection at 4 times
The data collection takes place after
query of symptoms before cannabis therapy, symptom change through standard therapy
quality of life improvement since standard therapy start and why cannabis therapy?
2. Questionnaire: After 1-2 months after starting treatment with cannabis therapy, pain intensity is measured, healt
Sponsors
Pharma
Eligibility
Sex/Gender
All
Age
25 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients must be older than 25 years. Diagnosis according to M79.7 must be confirmed; treatment goals must not have been achieved yet. At least two months without cannabis use.
Exclusion criteria
Exclusion criteria: Pregnancy and breastfeeding, history of psychosis/schizophrenia, intolerance/allergies to cannabis prescription drugs and their components
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain intensity (NRS scale): Measurement times Start point 0 of therapy without cannabis medication; measurement point 1-2 month with cannabis medication, measurement point 3-4 month with cannabis medication and measurement point 5-6 with cannabis medication Change in health-related quality of life (FIQR scale): Measurement times Start point 0 of therapy without cannabis medication; measurement point 1-2 month with cannabis medication, measurement point 3-4 month with cannabis medication and measurement point 5-6 with cannabis medication | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in drug guideline therapy Compatibility and safety of cannabis prescription drugs | — |
Countries
Germany
Contacts
Public ContactKonrad F. Cimander
Arzt
Outcome results
None listed