Brain Imaging Study on Biomarkers for Fibromyalgia
Fibromyalgia
About this trial
This is an interventional health services research trial for Fibromyalgia
Eligibility Criteria
Inclusion Criteria:
Chronic pain participant inclusion criteria:
- 18-75 years of age
- Right-handed
- Meet the classification criteria of chronic low back pain (having low back pain for more than 6 months).
- At least 4/10 clinical pain on the Brief Pain Inventory Scale on average during the two weeks prior to enrollment
- Comfortable completing (reading and writing) questionnaires and tasks with English language instructions
Healthy participant inclusion criteria:
- 18 - 75 years of age
- Right-handed
- Comfortable completing (reading and writing) questionnaires and tasks with English language instructions
Exclusion Criteria:
Chronic pain participant exclusion criteria:
- History of cardiac, respiratory, or nervous system disease that may interfere with participation in the study or cause heightened potential for adverse outcome. For example: asthma or claustrophobia
- Presence of any contraindications to MRI scanning. For example:
cardiac pacemaker, metal implants, fear of closed spaces, pregnancy
Healthy participant exclusion criteria:
- Acute or chronic pain
- History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment and by asking the participant about their comfort level and ability, precludes participation in the study because of a heightened potential for adverse outcome. For example: asthma or claustrophobia
- Presence of any contraindications to MRI scanning. For example:
cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.
Sites / Locations
- Nova Scotia Health AuthorityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
No Intervention
No Intervention
Experimental: placebos
Waitlist
Healthy Controls
Fibromyalgia participants will enter in an optional placebo trial. This phase of the study will test the clinical usefulness of the biomarkers. We will measure how expectation of starting a new treatment reduces 'clinical back pain' in each participant. Positive treatment expectations will be induced by giving them capsules containing inert material and telling them that the capsules contain an effective drug that has been approved for treating Chronic Back Pain. They will be requested to take two capsules four times a day and report their pain on paper forms organized as a calendar or on REDCap.
Fibromyalgia participants will not be given any placebo and will be requested to report their pain on paper forms organized as a calendar or on REDCap.
Healthy control participants will complete the main part of the study, but will not be asked to take a placebo or be placed on a waitlist.