NL-OMON28585
Recruiting
Not Applicable
A randomized, double blind, placebo-controlled study on the effect of 3 months treatment with the analgesic tapentadol on conditioned pain modulation (CPM) and pain relief in patients with chronic pain from fibromyalgia
eiden University Medical Center (LUMC)0 sites40 target enrollmentTBD
ConditionsFibromyalgia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fibromyalgia
- Sponsor
- eiden University Medical Center (LUMC)
- Enrollment
- 40
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
/A
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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