Mechanisms and Modulation of Pain Modulatory Capacity
Primary Purpose
Musculoskeletal Pain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Delayed onset muscle soreness.
Sponsored by
About this trial
This is an interventional other trial for Musculoskeletal Pain
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:
- 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
Sites / Locations
- Unversity of FloridaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Repeated exposure
Single exposure
Natural history
Arm Description
Participants will complete four exercise sessions designed to induce delayed onset muscle soreness in the biceps
Participants will complete one exercise session designed to induce delayed onset muscle soreness
Participants will complete all sensory testing and imaging but not perform any exercise sessions.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Cortical network connectivity
Functional magnetic resonance imaging of regional connectivity among pain-related brain regions
Full Information
NCT ID
NCT04441619
First Posted
June 11, 2020
Last Updated
May 1, 2023
Sponsor
University of Florida
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1. Study Identification
Unique Protocol Identification Number
NCT04441619
Brief Title
Mechanisms and Modulation of Pain Modulatory Capacity
Official Title
Mechanisms and Modulation of Pain Modulatory Capacity
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a mechanistic observational study
Masking
Outcomes Assessor
Masking Description
Assessments will be performed by an investigator who is not aware of the group assignment.
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Repeated exposure
Arm Type
Active Comparator
Arm Description
Participants will complete four exercise sessions designed to induce delayed onset muscle soreness in the biceps
Arm Title
Single exposure
Arm Type
Active Comparator
Arm Description
Participants will complete one exercise session designed to induce delayed onset muscle soreness
Arm Title
Natural history
Arm Type
No Intervention
Arm Description
Participants will complete all sensory testing and imaging but not perform any exercise sessions.
Intervention Type
Behavioral
Intervention Name(s)
Delayed onset muscle soreness.
Intervention Description
Participants will perform a fatiguing exercise protocol for the upper extremity (biceps muscles)
Primary Outcome Measure Information:
Title
Change in pain intensity
Description
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.
Time Frame
Baseline up to 10 weeks
Title
Change in thermal quantitative sensory testing
Description
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.
Time Frame
Baseline up to 10 weeks
Title
Change in pressure quantitative sensory testing
Description
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.
Time Frame
Baseline up to 10 weeks
Secondary Outcome Measure Information:
Title
Cortical network connectivity
Description
Functional magnetic resonance imaging of regional connectivity among pain-related brain regions
Time Frame
Baseline up to 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark D Bishop, PhD
Phone
352-2736112
Email
bish@ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jeff Boissoneault, PhD
Phone
352-2736147
Email
jboissoneault@phhp.ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael E Robinson, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unversity of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
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Mechanisms and Modulation of Pain Modulatory Capacity
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