NCT02991625

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
105mo left

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Jan 2018Jan 2035

First Submitted

Initial submission to the registry

December 8, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 22, 2018

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2035

Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

8.9 years

First QC Date

December 8, 2016

Last Update Submit

February 14, 2025

Conditions

Back Pain

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 days after first visit

Study Arms (3)

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.

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.

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.

Other: Healthy Controls

Interventions

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.

Placebos
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.

Waitlist
Healthy ControlsOTHER

Healthy control participants will not receive a placebo drug or be put on a waitlist.

Healthy Controls

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years of age
  • Right-handed
  • Comfortable completing (reading and writing) questionnaires and tasks with English language instructions

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Scotia Health Authoity QEII

Halifax, Nova Scotia, B3H1V7, Canada

Location

Related Publications (5)

  • 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.

    PMID: 23983029BACKGROUND

  • 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.

    PMID: 25955965BACKGROUND

  • 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.

    PMID: 24623770BACKGROUND

  • 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.

    PMID: 22985900BACKGROUND

  • Sunavsky 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.

    PMID: 40388641DERIVED

MeSH Terms

Conditions

Back Pain

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Javeria A Hashmi, PhD

    Dalhousie University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2016

First Posted

December 13, 2016

Study Start

January 22, 2018

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2035

Last Updated

February 17, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)