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临床试验/NCT04441619
NCT04441619已完成不适用

Mechanisms and Modulation of Pain Modulatory Capacity

University of Florida2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2020年11月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
128
试验地点
2
主要终点
Change in thermal quantitative sensory testing

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

Assessments will be performed by an investigator who is not aware of the group assignment.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

Repeated exposure

Active Comparator

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

干预措施: Delayed onset muscle soreness. (Behavioral)

Single exposure

Active Comparator

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

干预措施: Delayed onset muscle soreness. (Behavioral)

Natural history

No Intervention

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

结局指标

主要结局

Change in thermal quantitative sensory testing

时间窗: Baseline up to 10 weeks

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.

Change in pain intensity

时间窗: Baseline up to 10 weeks

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.

Change in pressure quantitative sensory testing

时间窗: Baseline up to 10 weeks

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.

次要结局

  • Cortical network connectivity(Baseline up to 10 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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