Chronic pain Nervous System Diseases
Conditions
Interventions
Patients with chronic pain, in whom doubts emanate from the patient or the practitioner about the efficacy of a given medication, will be separated in two arms after their inclusion:
I
Sponsors
University Hospital Lausanne (CHUV)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged over 18 years 2. Experiencing pain of any origin for at least 3 months and followed in one of the pain centers included in the trial 3. Patient or the practitioner has doubts about the efficacy of a given medication, either before initiation or during treatment 4. Informed consent form signed
Exclusion criteria
Exclusion criteria: 1. Contraindication to the class of drugs to be tested, e.g. known hypersensitivity or allergy 2. Specific disease or organ dysfunction, which would contraindicate the prescription of the planned medication 3. Evolving major comorbidity likely to worsen during the trial 4. Any situation where carrying out N-of-1 trial would put the patient at risk of side effects or withdrawal (e.g. high doses opiates) 5. Women who are pregnant or breast feeding 6. Intention to become pregnant during the course of the study 7. Lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. (Female participants who are surgically sterilised/hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.) 8. Inability to give informed consent 9. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant 10. Known or suspected non-compliance 11. Drug or alcohol abuse 12. Previous enrolment into the current trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of pain medications assessed by reviewing patient medical records at baseline and at 6 months. 2. Average pain intensity as recorded by the patient on a 2-week visual analogue scale (VAS) at baseline and at 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life assessed using the Short Form Health Survey SF-36 at inclusion and at 6 months 2. Estimation of the cost of N-of-1 trials taking into account the difference in financial burden of pain treatment 3. Consumption of analgesic medications and of other interventions against pain throughout the study, assessed by reviewing patient medical records. 4. Patient’s emotional state assessed by the psychologist using a Clinical Global Impression (CGI) scale at baseline and at 4 months 5. Patient's daily-life functioning assessed by the psychologist using the Hospital Anxiety and Depression Scale (HADS) questionnaire at baseline and at 4 months 6. Qualitative evaluation of patients’ and physician’s reactions towards the N-of-1 approach (respectively at 6 months and at the end of the whole trial), based on interviews | — |
Countries
Switzerland
Outcome results
None listed