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Brain Imaging Study on Biomarkers for Chronic Back Pain

Primary Purpose

Back Pain

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Placebos
Waitlist
Healthy Controls
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Back Pain

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), as determined by a physician and documented in the participant's medical record.
  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 Authoity QEII

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Other

Arm Label

Placebos

Waitlist

Healthy Controls

Arm Description

Chronic Back Pain participants will enter 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 twice a day and report their pain on paper forms organized as a calendar.

Chronic Back Pain participants will not be given any placebo and will be requested to report their pain on paper forms organized as a calendar.

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
December 8, 2016
Last Updated
September 25, 2023
Sponsor
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT02991625
Brief Title
Brain Imaging Study on Biomarkers for Chronic Back Pain
Official Title
Brain Imaging Study on Biomarkers for Chronic Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 22, 2018 (Actual)
Primary Completion Date
January 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
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 chronic pain. Treatment response to pain killers in a person may be related to their brain, genetics, 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).
Detailed Description
Drugs used for managing chronic pain have not proven to be effective and chronic 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 chronic pain. Treatment response to pain killers in a person may be related to their brain, genetics, 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, genetic). These 'experimental' data will be compared between chronic back pain (CBP) 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 CBP 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
Back Pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebos
Arm Type
Experimental
Arm Description
Chronic Back Pain participants will enter 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 twice a day and report their pain on paper forms organized as a calendar.
Arm Title
Waitlist
Arm Type
Other
Arm Description
Chronic Back Pain participants will not be given any placebo and will be requested to report their pain on paper forms organized as a calendar.
Arm Title
Healthy Controls
Arm Type
Other
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
Other
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 Back Pain. They will be requested to take two capsules twice a day and report their pain on paper forms organized as a calendar.
Intervention Type
Other
Intervention Name(s)
Waitlist
Intervention Description
These Chronic Back Pain participants will not be given any placebos and will be requested to report their pain on paper forms organized as a calendar.
Intervention Type
Other
Intervention Name(s)
Healthy Controls
Intervention Description
Healthy control participants will not receive a placebo drug or be put on a waitlist.
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), as determined by a physician and documented in the participant's medical record. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javeria A Hashmi, PhD
Organizational Affiliation
Dalhousie University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nova Scotia Health Authoity QEII
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H1V7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23983029
Citation
Hashmi JA, Baliki MN, Huang L, Baria AT, Torbey S, Hermann KM, Schnitzer TJ, Apkarian AV. Shape shifting pain: chronification of back pain shifts brain representation from nociceptive to emotional circuits. Brain. 2013 Sep;136(Pt 9):2751-68. doi: 10.1093/brain/awt211.
Results Reference
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PubMed Identifier
25955965
Citation
Vase L, Vollert J, Finnerup NB, Miao X, Atkinson G, Marshall S, Nemeth R, Lange B, Liss C, Price DD, Maier C, Jensen TS, Segerdahl M. Predictors of the placebo analgesia response in randomized controlled trials of chronic pain: a meta-analysis of the individual data from nine industrially sponsored trials. Pain. 2015 Sep;156(9):1795-1802. doi: 10.1097/j.pain.0000000000000217.
Results Reference
background
PubMed Identifier
24623770
Citation
Hashmi JA, Kong J, Spaeth R, Khan S, Kaptchuk TJ, Gollub RL. Functional network architecture predicts psychologically mediated analgesia related to treatment in chronic knee pain patients. J Neurosci. 2014 Mar 12;34(11):3924-36. doi: 10.1523/JNEUROSCI.3155-13.2014.
Results Reference
background
PubMed Identifier
22985900
Citation
Hashmi JA, Baria AT, Baliki MN, Huang L, Schnitzer TJ, Apkarian VA. Brain networks predicting placebo analgesia in a clinical trial for chronic back pain. Pain. 2012 Dec;153(12):2393-2402. doi: 10.1016/j.pain.2012.08.008. Epub 2012 Sep 15.
Results Reference
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Brain Imaging Study on Biomarkers for Chronic Back Pain

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