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Diagnostic and Prognostic Biomarkers for High-impact Chronic Pain: Development and Validation

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ClinicalTrials.gov Identifier: NCT04994249
Recruitment Status : Recruiting
First Posted : August 6, 2021
Last Update Posted : March 31, 2022
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Sean Mackey, Stanford University

Brief Summary:
To identify diagnostic and prognostic biomarker signatures of recovery versus having persisting high-impact chronic pain and functional disability in adults with Chronic Musculoskeletal Pain.

Condition or disease
Chronic Musculoskeletal Pain Pain Pain, Chronic Joint Pain

Detailed Description:

Our overall goal is to discover and validate diagnostic and prognostic biomarkers for musculoskeletal high-impact chronic pain. Chronic pain represents a public health crisis that affects 50-100 million Americans and costs over $500 billion dollars annually. Chronic musculoskeletal pain conditions comprise 70-80% of all chronic pain. The highest-need and most impacted patients are those with high-impact chronic pain (affecting ~20 million Americans), or pain associated with substantially restricted work, social, and self-care activities for six or more months. Chronic pain-and high-impact chronic pain in particular-is often treated with prescription opioids, and is linked to opioid-use disorder. Multidisciplinary chronic pain treatments show incomplete recovery at the population level. However, subgroups of individuals completely respond, do not change, or even worsen following pain management. Thus, robust and validated diagnostic and prognostic biomarkers are needed to identify those with high-impact chronic pain and determine the trajectory of outcome (i.e., recovery versus persistence), respectively. Such biomarkers are essential to develop safer, more effective patient-specific treatment strategies, particularly for those who are refractory to current treatment options.

Many factors have been shown to be (1) diagnostic for the severity and impact of chronic pain or (2) prognostic of the trajectory of chronic pain, including those that are related to the central nervous system (CNS; structure, function), psychosocial (e.g., anxiety, catastrophizing, social isolation), sensory (e.g., temporal summation, conditioned pain modulation),1functional (e.g., accelerometry), multiomic (e.g., immune, microbiome), and demographic. However, these studies are limited by (1) association rather than predictive validity; (2) small sample sizes; (3) homogenous populations limiting external validity; and (4) single modality factors. As chronic pain is a biopsychosocial condition, we need to measure broadly across these multiple dimensions; the most valuable insights will be gained by understanding not only individual pieces of data, but the relationships among them. Recognizing the critical need for rapid, valid, and clinically useful breakthroughs in signature discovery for risk- and treatment-stratification and novel therapeutic targets for chronic pain, as called for in the HEAL initiative, we aim to discover reliable, validated diagnostic and prognostic biomarker signatures of musculoskeletal high-impact chronic pain by integrating CNS, multiomic, sensory, functional, psychosocial, and demographic domains.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic and Prognostic Biomarkers for High-impact Chronic Pain: Development and Validation
Actual Study Start Date : March 21, 2022
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Primary Outcome Measures :
  1. Pain Interference: [ Time Frame: 6 months after baseline assessment ]
    Pain Interference using Patient-Reported Outcome Measurement Information System (PROMIS)-Pain Interference on a T score (mean: 50; standard deviation: 10) and Graded Chronic Pain Scale (GCPS)

Biospecimen Retention:   Samples With DNA
Blood for Multiomics and Stool for Microbiome

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Musculoskeletal high-impact chronic pain.

Inclusion Criteria:

  • 1) Inclusion criteria: Adults (18-80 years; ~64% female expected based on clinic distribution) with chronic MSP as categorized by the World Health Organization (WHO).

Exclusion Criteria:

  • 1) Chronic musculoskeletal pain (MSP) explained by inflammatory disease (e.g., rheumatoid arthritis, lupus) or CP with a primary diagnosis other than chronic MSP (e.g., neuropathic pain), (2) significant cognitive impairment, (3) MRI contraindication, (4) medical or psychiatric problems interfering with the study, (5) current medicolegal factors (e.g., open disability claim), (6) plans for surgery during the study, (7) pregnancy and (8) Children under the age of 18 will not be included in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04994249

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Contact: Anne Cunniffe Marcy, MSBH 6507216931 acmarcy@stanford.edu

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United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Anne Cunniffe Marcy, MSBH    650-721-6931    acmarcy@stanford.edu   
Principal Investigator: Sean Mackey, MD, PhD         
Sponsors and Collaborators
Stanford University
National Institute of Neurological Disorders and Stroke (NINDS)
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Principal Investigator: Sean Mackey, MD, PhD. Stanford University

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Responsible Party: Sean Mackey, Chief, Division of Pain Medicine Director, Stanford Systems Neuroscience and Pain Lab, Stanford University
ClinicalTrials.gov Identifier: NCT04994249    
Other Study ID Numbers: 60657
1R61NS118651-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 6, 2021    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sean Mackey, Stanford University:
Additional relevant MeSH terms:
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Musculoskeletal Pain
Chronic Pain
Neurologic Manifestations
Muscular Diseases
Musculoskeletal Diseases
Joint Diseases