NL-OMON26947RecruitingNot 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 low back pain
eiden University Medical Center (LUMC)0 sites40 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
/A
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •American Society of Anesthesiologists class 1 and 2 patients, 18 – 75 years; BMI < 40 kg/m2, and ability to give informed consent. Chronic Low Back Pain for > 3-months with a pain score of 5 or more on a numerical rating scale ranging from 0 (= no pain) to 10 (= most extreme pain imaginable).
- •To be enrolled in the study, patients need to have an 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; (ix) previous extensive spinal surgery or spinal surgery in the past 6 months; (x) serious spinal pathology and (xi) diagnosed neurological disease.
- •Patients are not allowed to continue co-analgesics that target CPM.
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