Isometric Exercise and Endogenous Pain Inhibition
1 other identifier
interventional
43
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 25, 2018
CompletedFirst Submitted
Initial submission to the registry
December 12, 2018
CompletedFirst Posted
Study publicly available on registry
December 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 29, 2019
CompletedFebruary 24, 2021
February 1, 2021
1.3 years
December 12, 2018
February 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Vibration Perception Threshold
baseline, immediately after exercise or quiet rest
Other Outcomes (1)
Numerical Pain Rating Scale (NPRS)
baseline, during exercise, and immediately after exercise or quiet rest
Study Arms (2)
Isometric Exercise
EXPERIMENTALParticipants will perform a submaximal voluntary contraction of the quadriceps muscle to task failure.
Quiet Rest
NO INTERVENTIONParticipants will sit quietly for a period of time that mimics the exercise.
Interventions
Participants will be asked to hold a submaximal voluntary contraction of the quadriceps muscle as long as they can (task failure).
Eligibility Criteria
You may qualify if:
- Men and women aged 18-75 diagnosed with fibromyalgia or healthy controls will be included in the study.
You may not qualify if:
- cardiovascular disease, cancer, pregnancy, arthritis, diabetes, claustrophobia, Reynaud's disease, osteoporosis, neuropathy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Marquette University
Milwaukee, Wisconsin, 53233, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie Hoeger Bement, PT, PhD
Marquette University
- STUDY DIRECTOR
Ali Alsouhibani, PT, MS
Marquette University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- The participant is masked to the hypotheses of the treatment.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2018
First Posted
December 19, 2018
Study Start
May 25, 2018
Primary Completion
September 29, 2019
Study Completion
October 29, 2019
Last Updated
February 24, 2021
Record last verified: 2021-02