NCT04994249

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.

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 all trials

Timeline
17mo left

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress76%
Mar 2022Dec 2027

First Submitted

Initial submission to the registry

July 29, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

March 21, 2022

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2027

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

5.1 years

First QC Date

July 29, 2021

Last Update Submit

February 18, 2026

Conditions

Chronic Musculoskeletal PainPainPain, ChronicJoint Pain

Keywords

Pain

Outcome Measures

Primary Outcomes (1)

  • Pain Interference:

    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)

    6 months after baseline assessment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Musculoskeletal high-impact chronic pain.

You may not qualify if:

  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

Related Publications (10)

  • Von Korff M, Scher AI, Helmick C, Carter-Pokras O, Dodick DW, Goulet J, Hamill-Ruth R, LeResche L, Porter L, Tait R, Terman G, Veasley C, Mackey S. United States National Pain Strategy for Population Research: Concepts, Definitions, and Pilot Data. J Pain. 2016 Oct;17(10):1068-1080. doi: 10.1016/j.jpain.2016.06.009. Epub 2016 Jul 1.

    PMID: 27377620BACKGROUND

  • Kutch JJ, Labus JS, Harris RE, Martucci KT, Farmer MA, Fenske S, Fling C, Ichesco E, Peltier S, Petre B, Guo W, Hou X, Stephens AJ, Mullins C, Clauw DJ, Mackey SC, Apkarian AV, Landis JR, Mayer EA; MAPP Research Network. Resting-state functional connectivity predicts longitudinal pain symptom change in urologic chronic pelvic pain syndrome: a MAPP network study. Pain. 2017 Jun;158(6):1069-1082. doi: 10.1097/j.pain.0000000000000886.

    PMID: 28328579BACKGROUND

  • Ung H, Brown JE, Johnson KA, Younger J, Hush J, Mackey S. Multivariate classification of structural MRI data detects chronic low back pain. Cereb Cortex. 2014 Apr;24(4):1037-44. doi: 10.1093/cercor/bhs378. Epub 2012 Dec 17.

    PMID: 23246778BACKGROUND

  • Brown JE, Chatterjee N, Younger J, Mackey S. Towards a physiology-based measure of pain: patterns of human brain activity distinguish painful from non-painful thermal stimulation. PLoS One. 2011;6(9):e24124. doi: 10.1371/journal.pone.0024124. Epub 2011 Sep 13.

    PMID: 21931652BACKGROUND

  • Feinstein AB, Sturgeon JA, Darnall BD, Dunn AL, Rico T, Kao MC, Bhandari RP. The Effect of Pain Catastrophizing on Outcomes: A Developmental Perspective Across Children, Adolescents, and Young Adults With Chronic Pain. J Pain. 2017 Feb;18(2):144-154. doi: 10.1016/j.jpain.2016.10.009. Epub 2016 Nov 5.

    PMID: 27825857BACKGROUND

  • Bhandari RP, Feinstein AB, Huestis SE, Krane EJ, Dunn AL, Cohen LL, Kao MC, Darnall BD, Mackey SC. Pediatric-Collaborative Health Outcomes Information Registry (Peds-CHOIR): a learning health system to guide pediatric pain research and treatment. Pain. 2016 Sep;157(9):2033-2044. doi: 10.1097/j.pain.0000000000000609.

    PMID: 27280328BACKGROUND

  • Sharifzadeh Y, Kao MC, Sturgeon JA, Rico TJ, Mackey S, Darnall BD. Pain Catastrophizing Moderates Relationships between Pain Intensity and Opioid Prescription: Nonlinear Sex Differences Revealed Using a Learning Health System. Anesthesiology. 2017 Jul;127(1):136-146. doi: 10.1097/ALN.0000000000001656.

    PMID: 28614083BACKGROUND

  • Karayannis NV, Baumann I, Sturgeon JA, Melloh M, Mackey SC. The Impact of Social Isolation on Pain Interference: A Longitudinal Study. Ann Behav Med. 2019 Jan 1;53(1):65-74. doi: 10.1093/abm/kay017.

    PMID: 29668841BACKGROUND

  • Sturgeon JA, Dixon EA, Darnall BD, Mackey SC. Contributions of physical function and satisfaction with social roles to emotional distress in chronic pain: a Collaborative Health Outcomes Information Registry (CHOIR) study. Pain. 2015 Dec;156(12):2627-2633. doi: 10.1097/j.pain.0000000000000313.

    PMID: 26230739BACKGROUND

  • Goodin BR, Bulls HW, Herbert MS, Schmidt J, King CD, Glover TL, Sotolongo A, Sibille KT, Cruz-Almeida Y, Staud R, Fessler BJ, Redden DT, Bradley LA, Fillingim RB. Temporal summation of pain as a prospective predictor of clinical pain severity in adults aged 45 years and older with knee osteoarthritis: ethnic differences. Psychosom Med. 2014 May;76(4):302-10. doi: 10.1097/PSY.0000000000000058.

    PMID: 24804882BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood for Multiomics and Stool for Microbiome

MeSH Terms

Conditions

PainChronic PainArthralgia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsJoint DiseasesMusculoskeletal Diseases

Study Officials

  • Sean Mackey, MD, PhD.

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Pain Medicine Director, Stanford Systems Neuroscience and Pain Lab

Study Record Dates

First Submitted

July 29, 2021

First Posted

August 6, 2021

Study Start

March 21, 2022

Primary Completion (Estimated)

April 25, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

February 20, 2026

Record last verified: 2026-02

Locations

US(1)