Cardiovascular Autonomic Function and Endogenous Pain Modulation

Marquette University

Status: Unknown

Conditions: Fibromyalgia; Physical Activity; Pain; Exercise; Autonomic Dysfunction

Treatments: Other: Cognitive Task; Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03911609

HR-1812027243

Details and patient eligibility

About

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).

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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250 participants in 2 patient groups

Isometric (Static) Exercise

Experimental group

Description:

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.

Treatment:

Other: Exercise

Cognitive Task

Experimental group

Description:

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.

Treatment:

Other: Cognitive Task