NL-OMON26947
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 low back pain
eiden University Medical Center (LUMC)0 sites40 target enrollmentTBD
Conditionsow back pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ow back pain
- 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, 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.
Outcomes
Primary Outcomes
Not specified
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