Back PainNCT02991625
Brain Imaging Study on Biomarkers for Chronic Back Pain
A study testing Waitlist in people with Back Pain, run by Nova Scotia Health Authority at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Back Pain
- What is being tested?
- Waitlist
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- 22 Jan 2018to Jan 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- Healthy participant inclusion criteria:
- 18 - 75 years of age
- Right-handed
- Comfortable completing (reading and writing) questionnaires and tasks with English language instructions
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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).
Read the 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.
- Conditions
- Back Pain
- Being tested
- Placebos, Waitlist, Healthy Controls
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlacebosOther
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.
WaitlistOther
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.
Healthy ControlsOther
Healthy control participants will not receive a placebo drug or be put on a waitlist.
| Study group | Role | What they receive |
|---|---|---|
| Placebos | Experimental | 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. Receives: Other: Placebos |
| Waitlist | Other | 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. Receives: Other: Waitlist |
| Healthy Controls | Other | 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. Receives: Other: Healthy Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days after first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study start22 Jan 2018
- Primary completionJan 2027 (estimated)
- Study completionJan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javeria A Hashmi, PhD, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991625
- Sponsor's protocol ID
- 1021846
- Status last verified
- Feb 2025
- First submitted
- 8 Dec 2016
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23983029Vase 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.
PubMed 25955965Hashmi 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.
PubMed 24623770Hashmi 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.
PubMed 22985900Sunavsky A, Hashmi MA, Robertson JW, Veinot J, Hashmi JA. The nucleus accumbens-prefrontal connectivity as a predictor of chronic low back pain. Pain. 2025 Oct 1;166(10):e363-e377. doi: 10.1097/j.pain.0000000000003620. Epub 2025 May 15.
PubMed 40388641Veinot J, Cane D, Hashmi JA. Low working memory underpins the association between aberrant functional properties of pain modulation circuitry and chronic back pain severity. J Pain. 2025 Mar;28:104795. doi: 10.1016/j.jpain.2025.104795. Epub 2025 Jan 30.
PubMed 39892486
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Imaging Study on Biomarkers for Chronic Back Pain
- ClinicalTrials.gov ID
- NCT02991625
- Acronym / sponsor ID
- 1021846
- Conditions
- Back Pain
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2035 (estimated)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebos | Experimental | Other: PlacebosChronic 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. |
| Waitlist | Other | Other: WaitlistChronic 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 Controls | Other | Other: Healthy ControlsHealthy 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlacebosPositive 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. | Other | Placebos |
| WaitlistThese 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. | Other | Waitlist |
| Healthy ControlsHealthy control participants will not receive a placebo drug or be put on a waitlist. | Other | Healthy Controls |
Primary outcome
Pain modulation - using an experimental task that tests a person's ability to form positive expectations
Time frame: 3 days after first visit
Brain imaging will be used to assess each participant's capacity to endogenously adjust pain perception with changes in expectations.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Background: PubMed 23983029Hashmi 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.
- Background: PubMed 25955965Vase 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.
- Background: PubMed 24623770Hashmi 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.
- Background: PubMed 22985900Hashmi 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.
- Derived from this study: PubMed 40388641Sunavsky A, Hashmi MA, Robertson JW, Veinot J, Hashmi JA. The nucleus accumbens-prefrontal connectivity as a predictor of chronic low back pain. Pain. 2025 Oct 1;166(10):e363-e377. doi: 10.1097/j.pain.0000000000003620. Epub 2025 May 15.
- Derived from this study: PubMed 39892486Veinot J, Cane D, Hashmi JA. Low working memory underpins the association between aberrant functional properties of pain modulation circuitry and chronic back pain severity. J Pain. 2025 Mar;28:104795. doi: 10.1016/j.jpain.2025.104795. Epub 2025 Jan 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Javeria A Hashmi, PhD principal investigator
Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Waitlist in people with Back Pain, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain modulation - using an experimental task that tests a person's ability to form positive expectations (time frame: 3 days after first visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02991625, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.