Testing Placebos for fibromyalgia
Official title: Brain Imaging Study on Biomarkers for Fibromyalgia
- 3 groups
- One site, in Halifax
- Recruiting
Interventions
- Medication
Placebos
Positive treatment expectations will be induced by giving participants capsules containing inert material and telling them that the capsules contain an effective drug that has been approved for treating Chronic 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.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Nova Scotia Health Authority
Halifax, Nova Scotia
Eligibility Criteria
See who this study is looking for19 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +18-75 years of age
- +18 - 75 years of age
- +Chronic pain participant inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →:
- +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 enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
- +Comfortable completing (reading and writing) questionnaires and tasks with English language instructions
- +Healthy participant inclusion criteria:
- +Right-handed
- +Comfortable completing (reading and writing) questionnaires and tasks with English language instructions
Exclusion
- −Chronic pain participant exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →:
- −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:
- −Healthy participant exclusion criteria:
- −Acute or chronic pain
- −History of cardiac, respiratory, or nervous system disease that, in the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'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
- −cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is looking at how care is delivered and organised, rather than at a treatment itself.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Group A receives PlacebosPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
Registry label: A: Experimental: placebos
Groups B and C receive no study treatment and are followed for comparison.
Registry label: B: Waitlist · C: Healthy Controls
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment at all, and is followed for comparison.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 75 years.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 35 people.
The study is currently expected to finish around January 2035.
The main measurement is taken over: 3 days after first visit.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
pain modulation- using an experimental task that tests a person's ability to form positive expectations — measured over 3 days after first visit.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT03910010 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About PlacebosDrug
Positive treatment expectations will be induced by giving participants capsules containing inert material and telling them that the capsules contain an effective drug that has been approved for treating Chronic 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.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 75 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment and is followed for comparison.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 75 years.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 3 days after first visit.
The study as a whole is currently expected to finish around 2035-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 35 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Halifax, Nova Scotia, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Drugs used for managing Fibromyalgia pain have not proven to be effective and pain continues to cost Canadians $60 billion a year without truly helping those who suffer. The study proposes to investigate the factors related to a person that can enhance or reduce the effectiveness of pain treatments in people suffering with Fibromyalgia pain. Treatment response to painkillers in a person may be related to their brain, social, and psychological makeup. The investigators aim to study these factors to identify and develop feasible and robust indicators based on a person's biological makeup (also called biomarkers). These biomarkers will allow doctors and researchers to predict more accurately which treatment and prevention strategies for a particular disease will work in which groups of people. These measures will offer new opportunities for improving treatment such as by tailoring treatment to meet the specific needs of each patient based on his/her biological and psychological makeup. Towards the specific aim, data will first be collected in several experimental domains for studying treatment expectations (cognitive, psychosocial, brain-related). These 'experimental' data will be compared between Fibromyalgia (FM) and healthy participants to yield new understanding of the factors that govern treatment response. At the end of experimental data collection, the investigators will collect data in the 'clinical' domain. Hence, at the end of the experimental sessions, a subset of FM participants will receive a mock drug (placebo disguised as an approved pain treatment) and another subset will provide pain ratings only and hence serve as a waiting list control for the placebo trial. Data will be studied in steps to understand factors that mediate treatment outcomes and finally the investigators will use advanced computational tools used for big data analysis and aim to identify factors that can be used as biomarkers and precision medicine tools.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.