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
Completed
- Conditions
- chronic widespread pain10028302
- Registration Number
- NL-OMON42796
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
-Age: 18 * 75 years.
- Sex: Either sex.
- American Society of Anesthesiologists class 1 and 2 patients, 18 * 75 years; BMI < 40 kg/m2, and ability to give informed consent.
Additionally 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
-defects in CPM
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Endogenous pain modulation (CPM) and pain relief by tapentadol vs placebo</p><br>
- Secondary Outcome Measures
Name Time Method <p>Endogenous pain modulation (OA) and central sensitization<br /><br>C-fiber morphology in the cornea<br /><br>Effect of tapentadol on mood and neuropathic pain complaints</p><br>