NCT04441619

Brief Summary

This project proposes to understand the sources of pain variability, and demonstrate that pain variability represents fluctuation in natural pain management. The project further proposes to determine if endogenous capacity to modulate pain can be trained to maximize their body's ability to manage pain, much as the way in which athletic performance can be trained.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress98%
Nov 2020Apr 2026

First Submitted

Initial submission to the registry

June 11, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

November 30, 2020

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

5.4 years

First QC Date

June 11, 2020

Last Update Submit

January 16, 2026

Conditions

Musculoskeletal Pain

Outcome Measures

Primary Outcomes (3)

  • Change in pain intensity

    Pain during movement and pain at rest using the visual analog scale (VAS). Scores are recorded every day by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.

    Baseline up to 10 weeks

  • Change in thermal quantitative sensory testing

    Thermal pain thresholds and suprathreshold responses will be collected using a numeric rating scale anchored 0 "no pain" and 10 "worst pain imaginable". Change will be calculated using simple change scores and more complex multi-level modeling.

    Baseline up to 10 weeks

  • Change in pressure quantitative sensory testing

    Pressure pain threshold will be collected using a numeric rating scale anchored 0 "no pain" and 10 "worst pain imaginable". Change will be calculated using simple change scores and more complex multi-level modeling.

    Baseline up to 10 weeks

Secondary Outcomes (1)

  • Cortical network connectivity

    Baseline up to 10 weeks

Study Arms (3)

Repeated exposure

ACTIVE COMPARATOR

Participants will complete four exercise sessions designed to induce delayed onset muscle soreness in the biceps

Behavioral: Delayed onset muscle soreness.

Single exposure

ACTIVE COMPARATOR

Participants will complete one exercise session designed to induce delayed onset muscle soreness

Behavioral: Delayed onset muscle soreness.

Natural history

NO INTERVENTION

Participants will complete all sensory testing and imaging but not perform any exercise sessions.

Interventions

Delayed onset muscle soreness.BEHAVIORAL

Participants will perform a fatiguing exercise protocol for the upper extremity (biceps muscles)

Repeated exposureSingle exposure

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Asymptomatic people (ie no current pain conditions)
  • Participants with widespread muscle pain (WMP) aged 18 years of age and older
  • Participants with WMP must meet the ACR (2010) diagnostic criteria of multiple regions of muscle pain
  • The asymptomatic group will be free of current wrist/hand, elbow, or shoulder pain and chronic pain conditions (eg irritable bowel syndrome, FM)

You may not qualify if:

  • Participation in a conditioning program specific to the biceps in the past 6 months
  • Any report of wrist/hand, elbow, or shoulder pain in the last 3 months
  • Any chronic medical conditions that may affect pain perception (e.g., diabetes, high blood pressure), kidney dysfunction, muscle damage, or major psychiatric disorder
  • Use of any intervention (including but not limited to medication, massage, and stretching) for symptoms induced by pain training for the duration of the study
  • Positive result on pre-MRI metal screening or pregnancy test due to contraindication for the MRI environment.
  • Any participant with ferromagnetic metal in the head, neck, or abdominal cavity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unversity of Florida

Gainesville, Florida, 32611, United States

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael E Robinson, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark D Bishop, PhD

CONTACT

352-2736112[email protected]

Jeff Boissoneault, PhD

CONTACT

352-2736147[email protected]

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessments will be performed by an investigator who is not aware of the group assignment.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This is a mechanistic observational study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 22, 2020

Study Start

November 30, 2020

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations

US(1)