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Isometric Exercise and Endogenous Pain Inhibition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03778476
Recruitment Status : Recruiting
First Posted : December 18, 2018
Last Update Posted : December 18, 2018
Information provided by (Responsible Party):
Marquette University

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Other: Isometric Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The two groups will participate in two sessions receiving intervention or no intervention in a randomized manner.
Masking: Single (Participant)
Masking Description: The participant is masked to the hypotheses of the treatment.
Primary Purpose: Treatment
Official Title: Isometric Exercise and Endogenous Pain Modulation
Actual Study Start Date : May 25, 2018
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Isometric Exercise
Participants will perform a submaximal voluntary contraction of the quadriceps muscle to task failure.
Other: Isometric Exercise
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Other Outcome Measures:
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03778476

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Contact: Marie Hoeger Bement, PT, PhD 4142886738

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United States, Wisconsin
Marquette University Recruiting
Milwaukee, Wisconsin, United States, 53233
Contact: Marie Hoeger Bement, PT, PhD    414-288-6738   
Sub-Investigator: Ali Alsouhibani, PT, MS         
Sponsors and Collaborators
Marquette University
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Principal Investigator: Marie Hoeger Bement, PT, PhD Marquette University
Study Director: Ali Alsouhibani, PT, MS Marquette University

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Responsible Party: Marquette University Identifier: NCT03778476     History of Changes
Other Study ID Numbers: HR3035
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marquette University:
pain sensitivity
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases