The FCAT
Recruiting
- Conditions
- Fibromyalgia
- Registration Number
- NL-OMON28585
- Lead Sponsor
- eiden University Medical Center (LUMC)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Conditioned Pain Modulation (CPM)<br /><br>- Temporal summation (TS)<br /><br>- Offset Analgesia (OA)<br /><br>- Pain relief
- Secondary Outcome Measures
Name Time Method - Pain Detect questionnaire<br /><br>- The Big Five Inventory<br /><br>- Profile Of Mood States<br /><br>- Neuropathic Pain Symptoms Inventory Questionnaire<br /><br>- Hospital Anxiety and Depression Scale (HADS)<br /><br>- C-fiber density in the cornea<br>