The influence of pharmacological conditioning with S-ketamine on pain sensitivity in patients with Fibromyalgia Syndrome

Recruiting

• Conditions: Chronische pijnstoornis; Diffuse myofascial pain syndrome; Muscular Rheumatism

• Registration Number: NL-OMON54449
• Lead Sponsor: niversiteit Leiden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

- Diagnosed with FMS by a rheumatologist
- Females
- Age between 18 and 75 years old
- Dutch speaking participants

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 <= 60), liver diseases or epilepsy)
- Presence of any severe psychiatric disease not related to symptoms of FMS
(e.g., schizophrenia, schizoaffective disorders, severe anxiety or depression
(HADS > 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint for this study is the change in pressure pain threshold<br /><br>levels from baseline measured with pressure stimuli due to the pharmacological<br /><br>conditioning with S(+)-ketamine compared to pharmacological conditioning with<br /><br>placebo medication. Pressure pain threshold levels are assessed with three<br /><br>pressure stimuli at two different body locations: hand and lower leg. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints are: change in pressure wind-up, aftersensations,<br /><br>clinical pain intensity, self-reported disease activity due to pharmacological<br /><br>conditoning, differences in quantitative sensory testing (QST*s) between body<br /><br>locations, extinction of pharmacological conditioning, variability of<br /><br>breathing, and medication side effects. </p><br>