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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03778476
Other study ID # HR3035
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 25, 2018
Est. completion date October 29, 2019

Study information

Verified date February 2021
Source Marquette University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to identify the acute effects of isometric exercise on the inhibition of pain in individuals with fibromyalgia.


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.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date October 29, 2019
Est. primary completion date September 29, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Isometric Exercise
Participants will be asked to hold a submaximal voluntary contraction of the quadriceps muscle as long as they can (task failure).

Locations

Country Name City State
United States Marquette University Milwaukee Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
Marquette University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Numerical Pain Rating Scale (NPRS) 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
Primary 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. baseline, immediately after exercise or quiet rest
Secondary Vibration Perception Threshold 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
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