Isometric Exercise and Endogenous Pain Inhibition

Sponsor
Marquette University (Other)
Overall Status
Completed
CT.gov ID
NCT03778476
Collaborator
(none)
43
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2
17.1
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Isometric Exercise
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
43 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.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
Actual Primary Completion Date :
Sep 29, 2019
Actual Study Completion Date :
Oct 29, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Conditioned Pain Modulation [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 [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Marquette University Milwaukee Wisconsin United States 53233

Sponsors and Collaborators

  • Marquette University

Investigators

  • Principal Investigator: Marie Hoeger Bement, PT, PhD, Marquette University
  • Study Director: Ali Alsouhibani, PT, MS, Marquette University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marquette University
ClinicalTrials.gov Identifier:
NCT03778476
Other Study ID Numbers:
  • HR3035
First Posted:
Dec 19, 2018
Last Update Posted:
Feb 24, 2021
Last Verified:
Feb 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marquette University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 24, 2021