Chronische pijnstoornis Diffuse myofascial pain syndrome Muscular Rheumatism
Conditions
Interventions
The S(+)-ketamine conditioning group receives a one-hour administration of
intravenous (IV) S(+)-ketamine, with a step-up dose regimen (0.1 - 0.2 -
0.3mg/kg/h), once a week, for three weeks in the a
Sponsors
Universiteit Leiden
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Diagnosed with FMS by a rheumatologist - Females - Age between 18 and 75 years old - Dutch speaking participants
Exclusion criteria
Exclusion criteria: - A medical diagnosis other than fibromyalgia explaining the chronic pain symptoms. - Presence of severe and/or uncontrolled co-morbidities: cardiovascular diseases (e.g., heart failure NYHA III or IV, or uncontrolled essential hypertension), neuromuscular diseases, pulmonary obstructive or restrictive diseases, kidney failure (eGFR 15), bipolar disorder, dissociative personality disorder, or (previous) addiction to strong analgesics. - Presence of any allergy for S(+)-ketamine, midazolam, ondansetron or flumazenil - Long term use of medicine that is contra-indicated when administering S(+)-ketamine or midazolam: NMDA-receptor antagonists, xanthine derivates, ergometrine, CYP3A4 liver enzyme inhibitors (e.g., verapamil, diltiazem, or certain antibiotics), CYP3A4 liver enzyme inductors (e.g., rifampicin, carbamazepine, fenytoin), and strong opioids (e.g., morphine, fentanyl, heroin) - Previous experience(s) with S(+)-ketamine in a medical setting or previous experience with recreational racemic Ketamine use. - Use of painkillers different than usual dose of treatment on the day of experimentation. - Use of alcohol or drugs 24 hours prior to the hospital visits - Use of caffeine 12 hours prior to the hospital visits - Body weight > 100kg or BMI >35 - Presence of pregnancy or lactation - Presence of an ICD, pacemaker or implanted medication pump - Presence of chronic pain at the local site of experimental pain stimuli or monitoring devices. - Implanted materials in either arm (e.g., non-removable piercings)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint for this study is the change in pressure pain threshold levels from baseline measured with pressure stimuli due to the pharmacological conditioning with S(+)-ketamine compared to pharmacological conditioning with placebo medication. Pressure pain threshold levels are assessed with three pressure stimuli at two different body locations: hand and lower leg. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are: change in pressure wind-up, aftersensations, clinical pain intensity, self-reported disease activity due to pharmacological conditoning, differences in quantitative sensory testing (QST*s) between body locations, extinction of pharmacological conditioning, variability of breathing, and medication side effects. | — |
Countries
Netherlands
Outcome results
None listed