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

Status

Completed

Conditions

Intervention / Treatment

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.

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

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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