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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 days after first visit
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
I am between 18 and 75 years old.
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I have had low back pain for more than 6 months.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 • NCT030146229%
Headache
5%
Injection Site Pain
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
Nova Scotia Health AuthorityLead Sponsor
258 Previous Clinical Trials
83,819 Total Patients Enrolled
1 Trials studying Fibromyalgia
100 Patients Enrolled for Fibromyalgia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are right-handed.You are right-handed and experience chronic pain.You are right-handed.I am between 18 and 75 years old.I have experienced an average pain level of at least 4 out of 10 in the past two weeks.You have any health issues that prevent you from having an MRI scan, like a pacemaker, metal implants, fear of small spaces, or being pregnant.I have had low back pain for more than 6 months.I am between 18 and 75 years old and suffer from chronic pain.I am comfortable with reading and writing in English for tasks and questionnaires.I am between 18 and 75 years old.I have a heart, lung, or nervous system condition that could affect my study participation.My average pain level has been 4 or more out of 10 in the past two weeks.I am comfortable with reading and writing in English for tasks and questionnaires.I am between 18 and 75 years old.I do not have any ongoing pain issues.I have had low back pain for more than 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Waitlist
- Group 2: Experimental: placebos
- Group 3: Healthy Controls
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to take part in this investigation?
"This research study is recruiting 35 individuals suffering from fibromyalgia who meet the age criteria of 18 to 75. To be eligible, participants should have an average clinical pain rating of 4/10 or higher on the Brief Pain Inventory Scale during the two weeks prior to enrollment and must be right-handed."
Answered by AI
How many participants are currently taking part in this research initiative?
"Affirmative. Per the information released on clinicaltrials.gov, this medical trial is actively looking for participants to join their research cohort. The study was initially advertised on February 1st 2021 and has been recently updated as of March 11th 2020. 35 people are needed from a single enrolment site."
Answered by AI
Are there any open slots for entrants in this research study?
"Confirmed, the clinicaltrial.gov page states that this medical trial is active and recruiting participants. It was initially posted on February 1st 2021 and had its last edit done in March 11th 2020."
Answered by AI
Does the trial accept applicants younger than thirty years old?
"The enrollment requirements for this trial state that the minimum age is 18 years old, and participants must not exceed 75."
Answered by AI
Who else is applying?
What state do they live in?
Nova Scotia
What site did they apply to?
Nova Scotia Health Authority
What portion of applicants met pre-screening criteria?
Met criteria
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