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Brain Imaging Study for Fibromyalgia

N/A

Recruiting

Research Sponsored by Nova Scotia Health Authority

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 - 75 years of age

At least 4/10 clinical pain on the Brief Pain Inventory Scale on average during the two weeks prior to enrollment

Must not have

Healthy participant: Acute or chronic pain

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 days after first visit

Summary

This trial aims to study the factors that can make pain treatments more or less effective for people suffering from Fibromyalgia pain. They will collect data from several domains to try and understand what exactly predicts treatment response in order to help doctors tailor treatments more specifically to each patient in the future.

Who is the study for?

This trial is for adults aged 18-75 with Fibromyalgia or chronic low back pain, experiencing at least moderate pain. Participants must be right-handed and comfortable with English tasks. It excludes those with certain diseases like asthma, claustrophobia, or conditions that conflict with MRI scanning such as having a pacemaker or being pregnant.

What is being tested?

The study tests how different factors like brain activity and psychological state influence the effectiveness of pain treatments in Fibromyalgia patients. Some participants will receive a placebo disguised as real medication to assess treatment expectations and response.

What are the potential side effects?

Since this trial uses placebos (substances with no active medical effect), side effects are not expected from the intervention itself; however, there may be discomforts related to undergoing an MRI scan.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

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I have experienced an average pain level of at least 4 out of 10 in the past two weeks.

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I have had low back pain for more than 6 months.

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I am between 18 and 75 years old.

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My average pain level has been 4 or more out of 10 in the past two weeks.

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I am between 18 and 75 years old.

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I have had low back pain for more than 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any ongoing pain issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 days after first visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 days after first visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 days after first visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

pain modulation- using an experimental task that tests a person's ability to form positive expectations.

Side effects data

From 2017 Phase 3 trial • 303 Patients • NCT03014622

Headache

Injection Site Pain

100%

80%

60%

40%

20%

Study treatment Arm

DaxibotulinumtoxinA 40 Units

Placebo

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Experimental: placebosExperimental Treatment1 Intervention

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.

Group II: WaitlistActive Control1 Intervention

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.

Group III: Healthy ControlsActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebos

2019

Completed Phase 4

~2030

0 / 8Eligibility criteria met