Clinical trial NCT03911609: Cardiovascular Autonomic Function and Endogenous Pain Modulation
Official title: The Influence of Cardiovascular Autonomic Function on Endogenous Pain Modulation Before and After Exercise and Cognitive Task in Fibromyalgia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Exercise
Pain
Autonomic Dysfunction
Physical Activity
Lead sponsor: Marquette University
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All subjects will participate in two randomized sessions (exercise session and cognitive task session). Experimental pain assessment will be performed before after both tasks.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from Baseline Pressure Pain Threshold to immediately after performance of exercise.
timeFrame: Before and immediately after exercise at session 2 or 3 which is on day 7 or day 21.
measure: Change from Baseline Pressure Pain Threshold to immediately after cognitive task.
timeFrame: Before and immediately after cognitive task at session 2 or 3 which is on day 7 or day 21.
measure: Change from Baseline Pressure Pain Threshold to during the submersion of the foot in ice water.
timeFrame: Before and during the submersion of the foot in ice water on session 2 which is day 7 of data collection
measure: Temporal summation of heat assessment.
timeFrame: the beginning of session 3 which day 21 of data collection
measure: Heart Rate Variability
timeFrame: baseline, session1 which is day 1 of data collection
measure: Change in Heart Rate during Deep Breathing Test
timeFrame: baseline, session 1 which is day 1 of data collection
measure: Change in Blood Pressure during Valsalva Maneuver
timeFrame: baseline, session 1 which is day 1 of data collection
Secondary outcomes:
measure: Total time spent in sedentary and moderate to vigorous physical activity measured by an Actigraph over the course of 7 days.
timeFrame: Worn continuously for a 7-day period during study enrollment.
measure: Cortisol Awakening Response (CAR)
timeFrame: samples will be collected at home at any day between day 1 and day 7 of data collection
measure: Six-Minute Walk Test
timeFrame: time frame: baseline, day 1 of data collection
measure: The Fibromyalgia Impact Questionnaire - Revised
timeFrame: on session 1, 2 and 3 which are on day 1,7 and 21 of data collection.
measure: The Short-Form McGill Pain Questionnaire
timeFrame: on session 1, 2 and 3 which are on day 1,7 and 21 of data collection
measure: Pain Catastrophizing Scale
timeFrame: on session 1 which is day 1 of data collection.
measure: American College of Rheumatology Diagnostic Criteria for Fibromyalgia
timeFrame: Day 1 of data collection
measure: Baseline Lean Mass
timeFrame: 7 days after enrollment.
measure: Baseline Fat Mass
timeFrame: 7 days after enrollment.
measure: Composite Autonomic Symptom Score
timeFrame: baseline, session1 which is day 1 of data collection
measure: Situational Pain Catastrophizing Scale
timeFrame: in session 2 and 3 which are day 7 and 21 of data collection
measure: Pain Anxiety Symptom Scale
timeFrame: session 3 which is day 21 of data collection
measure: Depression Anxiety and Stress Scale (DASS21)
timeFrame: session 3 which is day 21 of data collection
measure: State Version of State-Trait Anxiety Inventory
timeFrame: on session 1, 2 and 3 which are on day 1,7 and 21 of data collection.
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Marquette University
state: Wisconsin
Study officials:
affiliation: Marquette University
name: Marie Hoeger Bement, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: