NCT03778476

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2019

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

1.3 years

First QC Date

December 12, 2018

Last Update Submit

February 23, 2021

Conditions

Keywords

Exercisepain sensitivityfibromyalgia

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

EXPERIMENTAL

Participants will perform a submaximal voluntary contraction of the quadriceps muscle to task failure.

Other: Isometric Exercise

Quiet Rest

NO INTERVENTION

Participants 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).

Isometric Exercise

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

FibromyalgiaMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Marie Hoeger Bement, PT, PhD

    Marquette University

    PRINCIPAL INVESTIGATOR
  • Ali Alsouhibani, PT, MS

    Marquette University

    STUDY DIRECTOR

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
Model Details: The two groups will participate in two sessions receiving intervention or no intervention in a randomized manner.
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

Locations