Cardiovascular Autonomic Function and Endogenous Pain Modulation

NCT ID: NCT03911609

Last Updated: 2019-04-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-20
• Study Completion Date: 2022-12-30

Brief Summary

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).

Detailed Description

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.

Conditions

Fibromyalgia; Exercise; Pain; Autonomic Dysfunction; Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Cognitive Task

Intervention Type: OTHER

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

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Marquette University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie Hoeger Bement, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Marquette University

Locations

Marquette University

Milwaukee, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Marie K Hoeger Bement, PT, PhD

Role: CONTACT

mariehoeger.bement@marquette.edu

414-288-6738

Facility Contacts

Marie K Hoeger Bement, PT, PhD

Role: primary

mariehoeger.bement@marquette.edu

414-288-6738

Other Identifiers

HR-1812027243

Identifier Type: -

Identifier Source: org_study_id