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Brain Imaging Study on Biomarkers for Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Placebos
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Fibromyalgia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Chronic pain participant inclusion criteria:

    1. 18-75 years of age
    2. Right-handed
    3. Meet the classification criteria of chronic low back pain (having low back pain for more than 6 months).
    4. At least 4/10 clinical pain on the Brief Pain Inventory Scale on average during the two weeks prior to enrollment
    5. Comfortable completing (reading and writing) questionnaires and tasks with English language instructions

Healthy participant inclusion criteria:

  1. 18 - 75 years of age
  2. Right-handed
  3. Comfortable completing (reading and writing) questionnaires and tasks with English language instructions

Exclusion Criteria:

Chronic pain participant exclusion criteria:

  1. 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
  2. Presence of any contraindications to MRI scanning. For example:

cardiac pacemaker, metal implants, fear of closed spaces, pregnancy

Healthy participant exclusion criteria:

  1. Acute or chronic pain
  2. 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
  3. 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

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Experimental: placebos

Waitlist

Healthy Controls

Arm Description

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.

Outcomes

Primary Outcome Measures

pain modulation- using an experimental task that tests a person's ability to form positive expectations.
Brain imaging will be used to assess each participant's capacity to endogenously adjust pain perception with changes in expectations.

Secondary Outcome Measures

Full Information

First Posted
April 8, 2019
Last Updated
June 13, 2023
Sponsor
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT03910010
Brief Title
Brain Imaging Study on Biomarkers for Fibromyalgia
Official Title
Brain Imaging Study on Biomarkers for Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
February 2027 (Anticipated)
Study Completion Date
January 2035 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nova Scotia Health Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: placebos
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
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.
Arm Title
Healthy Controls
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
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.
Primary Outcome Measure Information:
Title
pain modulation- using an experimental task that tests a person's ability to form positive expectations.
Description
Brain imaging will be used to assess each participant's capacity to endogenously adjust pain perception with changes in expectations.
Time Frame
3 days after first visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Javeria A Hashmi, PhD
Phone
902-473-4603
Email
javeria.hashmi@dal.ca
Facility Information:
Facility Name
Nova Scotia Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3h1V7
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Brain Imaging Study on Biomarkers for Fibromyalgia

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