Brain Imaging Study on Biomarkers for Fibromyalgia

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Canada
Nova Scotia Health Authority
RECRUITING
Halifax
Contact Information
Primary
Javeria A Hashmi, PhD
javeria.hashmi@dal.ca
902-473-4603
Time Frame
Start Date: 2021-02-01
Estimated Completion Date: 2035-01
Participants
Target number of participants: 35
Treatments
Experimental: Experimental: placebos
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.
No_intervention: Waitlist
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.
No_intervention: Healthy Controls
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.
Related Therapeutic Areas
Sponsors
Leads: Nova Scotia Health Authority

This content was sourced from clinicaltrials.gov