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## Study Description

Chronic pain affects over 100 million Americans, with an annual cost estimated at over $500 billion. Reliance on opioid medications has led to an “opioid crisis” and the need to identify alternative treatment for chronic pain. This study hypothesizes that chronic pain represents failure or suboptimal function of pain modulatory capacity (PMC) and aims to test hypotheses about resilience to clinically relevant pain challenges, and test multisystem (psychological, behavioral, and neural) mechanisms underlying chronic pain. Furthermore, the study aims to demonstrate the trainability of PMC in asymptomatic controls, which has relevance for pain prevention, and in patients with fibromyalgia (FM) who are hypothesized to have suboptimal PMC (resilience) to pain challenges. 

The study team will test hypotheses about the trainability of endogenous pain modulation based on similar processes seen in other physiological systems. The research is highly innovative and challenges common and unsuccessful conceptualizations of pain treatment and variability. A typical target of pain treatment is the reduction of pain variability, however, this study hypothesizes that pain variability is a marker for PMC and treatment should focus on increasing this capacity rather than eliminating it. Demonstration of the modifiability of PMC will have a direct translation to both preventions of chronic pain and treatment of chronic pain.

**ELIGIBILITY CRITERIA:**

Ages Eligible for Study:           18 Years to 70 Years   (Adult, Older Adult)

Sexes Eligible for Study:          All

Accepts Healthy Volunteers:  Yes

**Inclusion Criteria:**
                      - Asymptomatic people (i.e., no current pain conditions)
                      - People with fibromyalgia (ACR (2010) diagnostic criteria)

 

**Exclusion Criteria:**
                      - 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
                      - Consumption of any drugs (e.g., alcohol, theophyline, tranquilizers, antidepressants) that may affect pain perception or hydration status 24 hr. before participation in a testing session
                      - Use of caffeine 4 or less hours before any testing session
                      - 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

**Study Design:**

Allocation:       Randomized 

Intervention Model: Parallel Assignment

Masking: Single (Outcomes Assessor)

Primary Purpose: Other

**Study Location(s):**

University of Florida, Gainesville, Florida, United States, 32611

**Study Website:**

https://clinicaltrials.gov/ct2/show/NCT04441619?term=NCT04441619&draw=2&rank=1

 

February 2021

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