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Cardiovascular Autonomic Function and Endogenous Pain Modulation

Study Purpose

The study has three aims: 1. To investigate the influence of cardiovascular autonomic function on pain sensitivity at rest in patients with fibromyalgia and age- and sex-matched controls. 2. To investigate the influence of cardiovascular autonomic function at baseline and during exercise on the pain response following submaximal isometric exercise. 3. To study the relation between the pain response following physical and cognitive tasks (exercise and mental math, respectively).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Fibromyalgia.
  • - Healthy Controls without fibromyalgia.
  • - Stable medical management plan for four weeks prior to participation in the study.
  • - Physical Activity Readiness Questionnaire.
  • - English proficiency.

Exclusion Criteria:

  • - Elbow arthritis.
  • - Carpal tunnel syndrome.
  • - Cardiovascular disease.
  • - Cervical surgery.
  • - Cerebrovascular accident / stroke.
  • - Multiple sclerosis.
  • - Parkinson's disease.
  • - Any central neurodegenerative disease.
  • - Traumatic brain injury.
  • - Peripheral neuropathy of the upper extremity.
  • - Myocardial infarction.
  • - Chronic obstructive pulmonary disease.
  • - Any unstable medical or psychiatric condition.
  • - Diabetes mellitus.
  • - Active cancer.
  • - Lymphedema of the upper extremity.
  • - Claustrophobia.
  • - Raynaud's phenomenon.
  • - Osteoporosis.
  • - Major depressive disorder.
  • - Bipolar disorder.
  • - Rheumatoid arthritis.
  • - Lupus.
  • - Polymyalgia rheumatica.
- Pregnancy

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03911609
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Marquette University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Marie Hoeger Bement, PT, PhD
Principal Investigator Affiliation Marquette University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Fibromyalgia, Exercise, Pain, Autonomic Dysfunction, Physical Activity
Additional Details

Fibromyalgia (FM) affects 2 -8% of the population with a higher prevalence in women than men. People with FM report widespread pain that impacts their quality of life. Patients may also experience other symptoms besides pain such as depression, anxiety, fatigue, sleep difficulties and others. Exercise is one of the interventions that have been shown to reduce pain in chronic pain populations. The phenomenon by which exercise reduces pain sensitivity is known as exercise-induced hypoalgesia (EIH). Although exercise is strongly recommended by American Pain Society guideline for the treatment of FM, some patients with FM report an increase in pain and worsening symptoms following acute exercise. The worsening of symptoms may impact adherence to exercise training. Why some people with FM report pain exacerbation while others report pain relief following exercise is not known. This study aims at assessing the influence of the cardiovascular autonomic nervous system on pain sensitivity at rest and following exercise in patients with fibromyalgia and pain-free individuals.

Arms & Interventions

Arms

Experimental: Isometric (Static) Exercise

Subjects will perform isometric (static) handgrip exercise at submaximal intensity for four minutes. The exercise will be performed while the subject is seated, and the elbow bent at around 90° and unsupported. Subjects will be asked to rate their pain using numerical pain rating scale that ranges from 0 (no pain) to 10 (worst pain), perceived exertion (RPE) from 0 (Nothing at all) to 10 (extremely strong), and perceived stress from 0 (not stressed at all) to 10 (extremely stressed). The ratings of pain intensity, RPE and perceived stress will be provided before, at the middle and at the end of the exercise.

Experimental: Cognitive Task

The mental math task, which is also known as serial subtraction test, will be performed for four minutes. Subjects will be asked to rate their pain intensity and perceived stress before, at the middle and at the end of the mental math task.

Interventions

Other: - Exercise

Subjects will perform isometric (static) handgrip exercise at submaximal intensity for four minutes. The exercise will be performed while the subject is seated, and the elbow bent at around 90° and unsupported. Subjects will be asked to rate their pain using numerical pain rating scale that ranges from 0 (no pain) to 10 (worst pain), perceived exertion (RPE) from 0 (Nothing at all) to 10 (extremely strong), and perceived stress from 0 (not stressed at all) to 10 (extremely stressed). The ratings of pain intensity, RPE and perceived stress will be provided before, at the middle and at the end of the exercise.

Other: - Cognitive Task

The mental math task, which is also known as serial subtraction test, will be performed for four minutes. Subjects will be asked to rate their pain intensity and perceived stress before, at the middle and at the end of the mental math task.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Marquette University, Milwaukee, Wisconsin

Status

Recruiting

Address

Marquette University

Milwaukee, Wisconsin, 53233

Site Contact

Marie K Hoeger Bement, PT, PhD

[email protected]

414-288-6738

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