Isometric Exercise and Endogenous Pain Inhibition
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Isometric Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Exercise, pain sensitivity, fibromyalgia
Eligibility Criteria
Inclusion Criteria:
- Men and women aged 18-75 diagnosed with fibromyalgia or healthy controls will be included in the study.
Exclusion Criteria:
- cardiovascular disease, cancer, pregnancy, arthritis, diabetes, claustrophobia, Reynaud's disease, osteoporosis, neuropathy.
Sites / Locations
- Marquette University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Isometric Exercise
Quiet Rest
Arm Description
Participants will perform a submaximal voluntary contraction of the quadriceps muscle to task failure.
Participants will sit quietly for a period of time that mimics the exercise.
Outcomes
Primary Outcome Measures
Conditioned Pain Modulation
the change in pressure pain threshold (kPa) during or after the immersion of the foot in a cold water bath (approximately 6 degrees) compared with baseline (before foot submersion) constitutes the measure of conditioned pain modulation in this study.
Secondary Outcome Measures
Vibration Perception Threshold
a biothesiometer will be used to measure sense of vibration (threshold) local and distal from the exercising muscle.
Full Information
NCT ID
NCT03778476
First Posted
December 12, 2018
Last Updated
February 23, 2021
Sponsor
Marquette University
1. Study Identification
Unique Protocol Identification Number
NCT03778476
Brief Title
Isometric Exercise and Endogenous Pain Inhibition
Official Title
Isometric Exercise and Endogenous Pain Modulation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 25, 2018 (Actual)
Primary Completion Date
September 29, 2019 (Actual)
Study Completion Date
October 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marquette University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to identify the acute effects of isometric exercise on the inhibition of pain in individuals with fibromyalgia.
Detailed Description
Fibromyalgia syndrome (FMS) is a chronic pain condition that is characterized by widespread pain which affects 5-8% of the general population. Past research has shown that people with FMS demonstrate enhanced pain facilitation and reduced pain inhibition in the central nervous system. Incorporating a biopsychosocial model of pain may help develop strategies to prevent the functional decline and alleviate the suffering that occurs in this population. Exercise is a mainstay of pain rehabilitation with multiple health benefits, one of which is decreasing pain; a phenomenon known as exercise induced hypoalgesia (EIH). Emerging evidence has shown that exercise decreases pain facilitation in healthy adults and in some individuals with FMS. However, it's unclear whether exercise improves pain inhibition in individuals with FMS. The purpose of this study is to investigate endogenous pain inhibition, measured by conditioned pain modulation (CPM), following isometric exercise of the quadriceps muscle in individuals with FMS. In addition, factors that might affect this response such as physical activity, body composition, and psychosocial issues will be examined. Understanding how exercise impacts pain and the contributing factors will help guide the prescription of exercise to optimize pain rehabilitation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Exercise, pain sensitivity, fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The two groups will participate in two sessions receiving intervention or no intervention in a randomized manner.
Masking
Participant
Masking Description
The participant is masked to the hypotheses of the treatment.
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Isometric Exercise
Arm Type
Experimental
Arm Description
Participants will perform a submaximal voluntary contraction of the quadriceps muscle to task failure.
Arm Title
Quiet Rest
Arm Type
No Intervention
Arm Description
Participants will sit quietly for a period of time that mimics the exercise.
Intervention Type
Other
Intervention Name(s)
Isometric Exercise
Intervention Description
Participants will be asked to hold a submaximal voluntary contraction of the quadriceps muscle as long as they can (task failure).
Primary Outcome Measure Information:
Title
Conditioned Pain Modulation
Description
the change in pressure pain threshold (kPa) during or after the immersion of the foot in a cold water bath (approximately 6 degrees) compared with baseline (before foot submersion) constitutes the measure of conditioned pain modulation in this study.
Time Frame
baseline, immediately after exercise or quiet rest
Secondary Outcome Measure Information:
Title
Vibration Perception Threshold
Description
a biothesiometer will be used to measure sense of vibration (threshold) local and distal from the exercising muscle.
Time Frame
baseline, immediately after exercise or quiet rest
Other Pre-specified Outcome Measures:
Title
Numerical Pain Rating Scale (NPRS)
Description
in both sessions, pain intensity will be evaluated during ice water bath immersion (i.e. before and after exercise or quiet rest) and during exercise using an 11-point NPRS with 0 being no pain and 10 worst pain possible.
Time Frame
baseline, during exercise, and immediately after exercise or quiet rest
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Men and women aged 18-75 diagnosed with fibromyalgia or healthy controls will be included in the study.
Exclusion Criteria:
cardiovascular disease, cancer, pregnancy, arthritis, diabetes, claustrophobia, Reynaud's disease, osteoporosis, neuropathy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Hoeger Bement, PT, PhD
Organizational Affiliation
Marquette University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ali Alsouhibani, PT, MS
Organizational Affiliation
Marquette University
Official's Role
Study Director
Facility Information:
Facility Name
Marquette University
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States
12. IPD Sharing Statement
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Isometric Exercise and Endogenous Pain Inhibition
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