NCT04441619

Mechanisms and Modulation of Pain Modulatory Capacity

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

Many physiological systems (bioenergy, immune etc.) involve feedback mechanisms to respond to challenges, with increased output or capacity for adaptive change. A similar process is plausible for pain modulation where previous successful pain experience and resolution suggests a pain modulatory system with adaptive capacity. The proposed research examines how a musculoskeletal training program modulates pain response in people with fibromyalgia compared to healthy individuals. Previous research suggests that moderate-high level exercise is associated with attenuation of pain sensitivity and clinical pain intensity in healthy individuals. The proposal seeks to extend findings from previous research and examine how repeated exposure and subsequent adaptations to musculoskeletal pain over time influence pain modulation (PMC). The first outcome is that people with fibromyalgia (FM) will have PMC trainability similar to asymptomatic controls, with the obvious implications for clinical application. The second outcome is that FM patients will demonstrate a deficit in PMC trainability. This outcome will represent an important diagnostic sign, and guide research to additional mechanistic investigation. The third outcome is that impaired or lessened PMC trainability is evident in FM patients and this variability can be explored as an individual difference with clinical implications. The theoretical fourth potential outcome is sensitization in FM patients, however pilot data show that DOMS resolves within the same relative time window as controls. Though not hypothesized, the data and design will allow for examination of this possibility. One potential conclusion from these projects could be that FM arises from an inability to enter a recovery period within which PMC could adapt and increase resilience. The proposal will be able to address at least some of the potential for this inability to recover.

Conditions

• Musculoskeletal Pain

Interventions

Type	Name	Description
BEHAVIORAL	Delayed onset muscle soreness.	Participants will perform a fatiguing exercise protocol for the upper extremity (biceps muscles)

Timeline

• Start date: 2020-11-30
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2020-06-22
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States