Clinical trial NCT04441619: Mechanisms and Modulation of Pain Modulatory Capacity
Official title: Mechanisms and Modulation of Pain Modulatory Capacity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Musculoskeletal Pain
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2020-06-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a mechanistic observational study
Primary purpose: OTHER

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

1. Participation in a conditioning program specific to the biceps in the past 6 months
2. Any report of wrist/hand, elbow, or shoulder pain in the last 3 months
3. Any chronic medical conditions that may affect pain perception (e.g., diabetes, high blood pressure), kidney dysfunction, muscle damage, or major psychiatric disorder
4. 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
5. Positive result on pre-MRI metal screening or pregnancy test due to contraindication for the MRI environment.
6. Any participant with ferromagnetic metal in the head, neck, or abdominal cavity

Primary outcomes:
measure: Change in pain intensity
timeFrame: Baseline up to 10 weeks
measure: Change in thermal quantitative sensory testing
timeFrame: Baseline up to 10 weeks
measure: Change in pressure quantitative sensory testing
timeFrame: Baseline up to 10 weeks
Secondary outcomes:
measure: Cortical network connectivity
timeFrame: Baseline up to 10 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Unversity of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Michael E Robinson, PhD
role: PRINCIPAL_INVESTIGATOR
References: