Clinical trial NCT03778385: Influence of Exercise Type, Pain Mechanisms, and Biopsychosocial Contributions to Pain Relief in Those With Fibromyalgia
Official title: Exercise Specificity and Endogenous Pain Modulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Exercise
Pain
Physical Activity
Body Composition
Lead sponsor: Marquette University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2018-12-19
Enrollment: 99
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 exercise sessions. Clinical and experimental pain assessment will be performed before, during, and after each exercise task.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the influence different types of exercise, pain mechanisms, and biopsychosocial contributions on how people with and without fibromyalgia report pain. Exercise will be performed with the arm at a submaximal intensity. Participants will undergo a variety of pain assessments, including clinical questionnaires and pain perception. This study will improve our understanding of how people with and without fibromyalgia respond to different resistance exercise types and whether physical activity and body composition has an influence on the response.

Detailed description: Fibromyalgia is a chronic widespread pain condition that is mostly prevalent in middle-aged women. Exercise is one of the few therapies that can alleviate fibromyalgia symptoms. Despite exercise being a major component of rehabilitation, exercise guidelines are unclear, often leading to symptom exacerbation and low compliance. Previous research has demonstrated that women with fibromyalgia may have different post-exercise pain responses when undergoing an exercise task. Factors critical to optimal exercise prescription are not known, including the most effective type of exercise, mechanisms responsible for pain relief, and biopsychosocial influences. This study investigates the use of exercise as a nonpharmacological pain management tool for people with fibromyalgia.

The purpose of this study is to investigate the acute exercise-induced pain response after isometric and dynamic muscle contractions in people with and without fibromyalgia. All participants will attend up to three sessions with approximately one week between sessions at a metropolitan university laboratory setting. Participants will perform different types of submaximal exercise for a maximum of ten minutes and complete pain assessments each session. Pain and psychosocial influences are measured with multiple established clinical questionnaires. Pressure pain sensitivity is tested by application of a mechanical stimulus to the arms and legs. To investigate a participant's innate ability to inhibit pain, the mechanical stimulus will be assessed with and without limb submersion in a cold-water bath. Physical activity is measured via questionnaire and use of activity monitors, while body composition is measured with a dual energy x-ray absorptiometry scan.

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 (PAR-Q)
* English proficiency

Exclusion Criteria:

* Elbow arthritis
* Carpal tunnel syndrome
* 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 Short-Form McGill Pain Questionnaire to 7-days after performance of exercise.
timeFrame: Before and up to 7-days after performance of exercise.
measure: Change from Baseline Fibromyalgia Impact Questionnaire to 7-days after performance of exercise.
timeFrame: Before and up to 7-days after performance of exercise.
measure: Change from Baseline Pain Rating from a Pressure Pain Device to immediately after performance of exercise.
timeFrame: Before and immediately after performance of exercise.
measure: Change from Baseline Pressure Pain Threshold to immediately after performance of exercise.
timeFrame: Before and immediately after exercise.
measure: Change from Baseline Numerical Pain Rating Scale to 7-days after performance of exercise.
timeFrame: Before, during, and up to 7-days after performance of exercise.
measure: Change in Pain Catastrophizing before to after exercise.
timeFrame: Through study completion, an average of 3 weeks.
measure: Baseline Tampa Scale of Kinesiophobia - 11
timeFrame: At the beginning of each session.
measure: Change from Baseline PROMIS Short Form v1.0 - Fatigue 7a at completion of study.
timeFrame: At the beginning of each exercise session.
measure: American College of Rheumatology Diagnostic Criteria for Fibromyalgia
timeFrame: At the beginning of each session.
measure: Conditioned Pain Modulation
timeFrame: Day 1 of enrollment
measure: Physical Activity Assessment Tool
timeFrame: Up to 7 days.
measure: Total time spent in sedentary and moderate to vigorous physical activity measured by an Actigraph wGT3x over the course of 7 days.
timeFrame: Worn continuously for a 7-day period during study enrollment.
measure: Baseline Lean Mass
timeFrame: 7 to 14 days after enrollment.
measure: Baseline Fat Mass
timeFrame: 7 to 14 days after enrollment.
Secondary outcomes:
measure: Change from Baseline Maximal Voluntary Force to immediately after performance of exercise.
timeFrame: Before and immediately after performance of exercise.
measure: Baseline voluntary muscle activation of the biceps muscle
timeFrame: Through study completion, an average of 3 weeks.
measure: Change from Baseline Heart Rate to immediately after performance of exercise.
timeFrame: Measured before, during, and immediately after exercise.
measure: Change from Baseline Blood Pressure to immediately after performance of exercise.
timeFrame: Measured before, during, and immediately after exercise.
measure: Change from Baseline Rating of Perceived Exertion to immediately after performance of exercise
timeFrame: Measured before, during, and immediately after exercise.
measure: Baseline sensory threshold assessed with von Frey monofilaments
timeFrame: At the beginning of each session.
measure: Change from baseline pain unpleasantness up to 7 days after exercise.
timeFrame: Before, during, and up to 7-days after performance of exercise.
measure: Change from baseline PROMIS Short Form v1.0 Pain Interference 6b up to 7 days after exercise.
timeFrame: Before, during, and up to 7-days after performance of exercise.
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Marquette University
state: Wisconsin
Study officials:
affiliation: Marquette University
name: Marie K Hoeger Bement, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: