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Isometric Exercise and Endogenous Pain Inhibition

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ClinicalTrials.gov Identifier: NCT03778476
Recruitment Status : Recruiting
First Posted : December 18, 2018
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
Marquette University

Tracking Information
First Submitted Date  ICMJE December 12, 2018
First Posted Date  ICMJE December 18, 2018
Last Update Posted Date December 18, 2018
Actual Study Start Date  ICMJE May 25, 2018
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2018)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 17, 2018)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Isometric Exercise and Endogenous Pain Inhibition
Official Title  ICMJE Isometric Exercise and Endogenous Pain Modulation
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Fibromyalgia
Intervention  ICMJE Other: Isometric Exercise
Participants will be asked to hold a submaximal voluntary contraction of the quadriceps muscle as long as they can (task failure).
Study Arms  ICMJE
  • Experimental: Isometric Exercise
    Participants will perform a submaximal voluntary contraction of the quadriceps muscle to task failure.
    Intervention: Other: Isometric Exercise
  • No Intervention: Quiet Rest
    Participants will sit quietly for a period of time that mimics the exercise.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 17, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Marie Hoeger Bement, PT, PhD 4142886738 mariehoeger.bement@marquette.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03778476
Other Study ID Numbers  ICMJE HR3035
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marquette University
Study Sponsor  ICMJE Marquette University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marie Hoeger Bement, PT, PhD Marquette University
Study Director: Ali Alsouhibani, PT, MS Marquette University
PRS Account Marquette University
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP