Patients diagnosed with a fibromyalgia syndrome as established by the 2016 ACR criteria and presenting criteria of central sensitization syndrome (based of the CSI (CSI>40)).
Conditions
Interventions
Trade Name: Vesierra
Product Name: Vesierra
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: ESKETAMINE
CAS Number: 33643-46-8
Concentration unit: mg/kg milligram(s)/kilogram
Concentrat
Sponsors
Grand Hôpital de Charleroi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - patients suffering from chronic pain (as defined by IASP) being diagnosed as fibromyalgia according to the ACR 2016 criteria - patients from the Grand Hôpital de Charleroi pain clinic (Sainte-Thérèse) - patients qualified for the treatment by S-ketamine as established by our latest clinical practice - patients aged 18-65 years old - patients having no experience of previous treatment by ketamine or S-ketamine for fibromyalgia - patients with a score > 40 at the central sensitization inventory Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: - Pregnant or breastfeeding women (based on patient interrogation and pregnancy test for women in the age to procreate ) A pregnancy discovered during the study will be reported to the ethics committee - Women of childbearing age not using an approved contraceptive method - History of psychiatric disorders as psychosis - Incapacity of giving an informed consent (concerns also patients with a linguistic barrier) - Allergy to any of the products used in the trial - Contraindication to any of the products used in the trial - Patients with any medical condition or medication inconsistent with the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: S-ketamine (low-dose versus high dose) can significantly improve the quality of life (pain and/or and autonomy) of patients diagnosed with a fibromyalgia syndrome as established by the 2016 ACR criteria and presenting criteria of central sensitization syndrome (based of the CSI (CSI>40)). S-ketamine has therefore its place as one of the treatments of fibromyalgic patients with a central sensitization syndrome not improved by a bio-psycho-social approach established by the EULAR guidelines;Secondary Objective: Not applicable;Primary end point(s): -BPI (Brief Pain Inventory) pain severity scale -BPI (Brief Pain Inventory) pain interference scale ;Timepoint(s) of evaluation of this end point: Timepoints to evaluate will be done at screening, at week 2, at week 4, at week 6, at week 9 and at week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number of patients showing a 50% reduction in the BPI pain index as asked by the item number 6 of the BPI - Impact of the treatment by esketamine on patient quality of life as measuring by the EQ5D-5L questionnaire - Impact of the treatment on emotional status evaluated by the HADS (Hospital Anxiety and Depression Scale) questionnaire - Incidence of the side effects of the treatment - Patient global satisfaction with the treatment as evaluated by the PGIC (Patient Global Impression of Change scale) questionnaire - Evolution of the central sensitization inventory;Timepoint(s) of evaluation of this end point: Timepoints to evaluate will be done at screening, at week 2, at week 4, at week 6, at week 9 and at week 12. | — |
Countries
Belgium
Contacts
Public ContactHead of Anesthesia Unit
Grand Hôpital de Charleroi
Outcome results
None listed