Cardiovascular Autonomic Function and Endogenous Pain Modulation

NCT03911609 | Unknown

• 1 other identifier: HR-1812027243
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The study has three aims:

1. 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. 2.To investigate the influence of cardiovascular autonomic function at baseline and during exercise on the pain response following submaximal isometric exercise
3. 3.To study the relation between the pain response following physical and cognitive tasks (exercise and mental math, respectively).

Conditions

Fibromyalgia; Exercise; Pain; Autonomic Dysfunction; Physical Activity

Outcome Measures

Primary Outcomes (7)

• Change from Baseline Pressure Pain Threshold to immediately after performance of exercise.

  Application of a pressure stimulus to the right forearm and quadriceps muscle at a rate of 50kPa per second until the pressure first becomes painful.

  Before and immediately after exercise at session 2 or 3 which is on day 7 or day 21.

• Change from Baseline Pressure Pain Threshold to immediately after cognitive task.

  Application of a pressure stimulus to the right forearm muscle and quadriceps muscle at a rate of 50kPa per second until the pressure first becomes painful.

  Before and immediately after cognitive task at session 2 or 3 which is on day 7 or day 21.

• Change from Baseline Pressure Pain Threshold to during the submersion of the foot in ice water.

  Application of a pressure stimulus to the right forearm muscle and quadriceps muscle at a rate of 50kPa per second until the pressure first becomes painful.

  Before and during the submersion of the foot in ice water on session 2 which is day 7 of data collection

• Temporal summation of heat assessment.

  Subjects will receive ten heat pulses with ramp and return rate of 8˚C/second to the baseline temperature. The peak stimulus interval 0.6 second and the inter-stimulus interval is 0.3 seconds. The baseline temperature will be 39˚C. Subjects will be asked to rate the first, third, fifth, eighth and tenth stimuli.

  the beginning of session 3 which day 21 of data collection

• Heart Rate Variability

  Electrocardiogram data will be recorded for ten minutes. Subjects will be instructed to relax. A two-lead configuration method will be utilized with electrodes placed at right clavicle (negative electrode), left lower rib (positive electrode), and left clavicle (ground electrode).

  baseline, session1 which is day 1 of data collection

• Change in Heart Rate during Deep Breathing Test

  The test is done by asking the participant to perform six breathing cycles with each cycle consists of a five seconds inhalation and 5 seconds exhalation (10 second-cycle). Subjects will perform practice trials until they perform respiratory cycles without sudden inhalation or exhalation or holding the breath. Continuous electrocardiogram data will be collected. The change of heart rate during deep breathing test reflects the cardiovascular parasympathetic function. Reduced heart rate variability during deep breathing test indicates reduced parasympathetic tone.

  baseline, session 1 which is day 1 of data collection

• Change in Blood Pressure during Valsalva Maneuver

  Subjects will be instructed to perform a forceful expiration at a pressure of 40 mm Hg for 15 seconds. This is done by blowing into a syringe that is connected to a pressure gauge, which will be placed in front of the subjects for visual feedback. In addition, feedback of the time will be provided. Continuous blood pressure will be collected during the test. The recovery time of blood pressure to baseline after Valsalva reflects the cardiovascular sympathetic tone. Greater recovery time indicates reduced sympathetic tone.

  baseline, session 1 which is day 1 of data collection

Secondary Outcomes (14)

• Total time spent in sedentary and moderate to vigorous physical activity measured by an Actigraph over the course of 7 days.

  Worn continuously for a 7-day period during study enrollment.

• Cortisol Awakening Response (CAR)

  samples will be collected at home at any day between day 1 and day 7 of data collection

• Six-Minute Walk Test

  time frame: baseline, day 1 of data collection

• The Fibromyalgia Impact Questionnaire - Revised

  on session 1, 2 and 3 which are on day 1,7 and 21 of data collection.

• The Short-Form McGill Pain Questionnaire

  on session 1, 2 and 3 which are on day 1,7 and 21 of data collection

Study Arms (2)

Isometric (Static) Exercise

EXPERIMENTAL

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: Exercise

Cognitive Task

EXPERIMENTAL

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.

Other: Cognitive Task

Interventions

Exercise 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.

Isometric (Static) Exercise

Cognitive Task 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.

Cognitive Task

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marquette University: lead

Study Sites (1)

Marquette University

Milwaukee, Wisconsin, 53233, United States

RECRUITING

MeSH Terms

Conditions

Fibromyalgia; Motor Activity; Pain; Primary Dysautonomias

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Autonomic Nervous System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Marie Hoeger Bement, PT, PhD

  Marquette University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie K Hoeger Bement, PT, PhD

CONTACT

414-288-6738; mariehoeger.bement@marquette.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are masked to the primary hypothesis of the study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All subjects will participate in two randomized sessions (exercise session and cognitive task session). Experimental pain assessment will be performed before after both tasks.

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 11, 2019
• Study Start: March 20, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: April 11, 2019

Record last verified: 2019-04

Locations

US (1)