Fibromyalgia
Conditions
Interventions
Patients will be treated with a placebo or Tapentadol for 3 months.
Sponsors
Leiden University Medical Center (LUMC)
Eligibility
Inclusion criteria
Inclusion criteria: American Society of Anesthesiologists class 1 and 2 patients, 18 – 75 years; BMI < 40 kg/m2. Patients need to have a pain score ≥ 5 (on a scale of 0-10) for most of the day and meet the 2010 American College of Rheumatology diagnostic criteria. Patients need to have a absent/inactive CPM response.
Exclusion criteria
Exclusion criteria: Unable to give written informed consent; medical disease such as pulmonary, renal, liver, cardiac, gastro-intestinal, vascular disease; (iii) allergy to study medication; (iv) history of illicit drug abuse or alcohol abuse; (v) history of psychosis; (vi) epilepsy; (vii) pregnancy and/or lactation; (viii) strong opioids and benzodiazepine use. Patients are not allowed to continue co-analgesics that target CPM.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Conditioned Pain Modulation (CPM) - Temporal summation (TS) - Offset Analgesia (OA) - Pain relief | — |
Secondary
| Measure | Time frame |
|---|---|
| - Pain Detect questionnaire - The Big Five Inventory - Profile Of Mood States - Neuropathic Pain Symptoms Inventory Questionnaire - Hospital Anxiety and Depression Scale (HADS) - C-fiber density in the cornea | — |
Contacts
Public ContactM. Niesters
Leiden University Medical Center
Outcome results
None listed