- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03778476
Isometric Exercise and Endogenous Pain Inhibition
February 23, 2021 updated by: Marquette University
Isometric Exercise and Endogenous Pain Modulation
The purpose of this study is to identify the acute effects of isometric exercise on the inhibition of pain in individuals with fibromyalgia.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53233
- Marquette University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Isometric Exercise
Participants will perform a submaximal voluntary contraction of the quadriceps muscle to task failure.
|
Participants will be asked to hold a submaximal voluntary contraction of the quadriceps muscle as long as they can (task failure).
|
|
No Intervention: Quiet Rest
Participants will sit quietly for a period of time that mimics the exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Conditioned Pain Modulation
Time Frame: baseline, immediately after exercise or quiet rest
|
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.
|
baseline, immediately after exercise or quiet rest
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vibration Perception Threshold
Time Frame: baseline, immediately after exercise or quiet rest
|
a biothesiometer will be used to measure sense of vibration (threshold) local and distal from the exercising muscle.
|
baseline, immediately after exercise or quiet rest
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numerical Pain Rating Scale (NPRS)
Time Frame: baseline, during exercise, and immediately after exercise or quiet rest
|
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.
|
baseline, during exercise, and immediately after exercise or quiet rest
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marie Hoeger Bement, PT, PhD, Marquette University
- Study Director: Ali Alsouhibani, PT, MS, Marquette University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 25, 2018
Primary Completion (Actual)
September 29, 2019
Study Completion (Actual)
October 29, 2019
Study Registration Dates
First Submitted
December 12, 2018
First Submitted That Met QC Criteria
December 17, 2018
First Posted (Actual)
December 19, 2018
Study Record Updates
Last Update Posted (Actual)
February 24, 2021
Last Update Submitted That Met QC Criteria
February 23, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HR3035
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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