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Influence of Exercise Type, Pain Mechanisms, and Biopsychosocial Contributions to Pain Relief in Those With Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
Marquette University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Exercise, Pain, Physical Activity, Body Composition

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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 (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

Sites / Locations

  • Marquette University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Isometric Exercise

Dynamic Exercise

Arm Description

Submaximal isometric resistance exercise of the arm.

Submaximal dynamic resistance exercise of the arm.

Outcomes

Primary Outcome Measures

Change from Baseline Short-Form McGill Pain Questionnaire to 7-days after performance of exercise.
The Short-Form McGill Pain Questionnaire is a multi-dimensional tool to assess pain quality in chronic pain patients. Participants rate the intensity of pain and related symptoms they felt during the past week on 0 to 3 scale, with 0 being no pain and 3 being severe. The total score ranges from a minimum of 0 to maximum 45 with higher scores indicating worse symptoms.
Change from Baseline Fibromyalgia Impact Questionnaire to 7-days after performance of exercise.
The Fibromyalgia Impact Questionnaire - Revised measures function, overall impact, and symptoms of fibromyalgia. Participants rate the difficulty in performing daily tasks, the impact of their symptoms, and intensity of fibromyalgia symptoms on a 0 to 10 scale, with 10 signifying greater significance. The total score ranges from a minimum of 0 to maximum of 210 with higher scores indicating worse function and symptoms.
Change from Baseline Pain Rating from a Pressure Pain Device to immediately after performance of exercise.
Application of mechanical stimulus through a weighted Lucite edge will be applied to the finger for a maximal duration of 2 minutes. Subjects will provide a pain rating every 20 seconds during the 2-minute test. Pain ratings are provided with use of a Numerical Pain Rating Scale that ranges from 0 (no pain) to 10 (worst pain).
Change from Baseline Pressure Pain Threshold to immediately after performance of exercise.
Application of a pressure stimulus is applied to the bicep muscle and quadriceps muscle at a rate of 50kPa per second until the pressure first becomes painful.
Change from Baseline Numerical Pain Rating Scale to 7-days after performance of exercise.
Pain in the exercising limb and whole body will be reported. Pain ratings are provided with use of a Numerical Pain Rating Scale that ranges from 0 (no pain) to 10 (worst pain).
Change in Pain Catastrophizing before to after exercise.
Measures the exaggerated negative mental set brought to bear during an actual or anticipated painful experience. Measured with the Pain Catastrophizing Scale which has subscales of rumination, magnification, and helplessness. Rumination scale ranges from 0 to 16 with higher score indicating higher levels of rumination. Magnification scale ranges from 0 to 12 with higher scores indicating higher levels of magnification. Helplessness scale ranges from 0 to 24 with higher scores indicating higher levels of helplessness. The subscale scores are summed to compute a total score ranging from 0 to 52 with higher scores indicating higher levels of pain catastrophizing.
Baseline Tampa Scale of Kinesiophobia - 11
Measures pain-related fear in relation to movement or avoidance type behaviors. A total score is computed ranging from 0 to 44 with higher scores indicating higher levels of pain-related fear.
Change from Baseline PROMIS Short Form v1.0 - Fatigue 7a at completion of study.
Measures the experience and impact of fatigue on daily activity. The PROMIS Short Form v1.0 - Fatigue 7a measures subjective feelings of tiredness to a sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Participants rank the level of tiredness on a scale of 1 (never) to 5 (always). The total score ranges from 7 to 35 with 35 indicating greater levels of exhaustion that impacts ability to perform daily tasks.
American College of Rheumatology Diagnostic Criteria for Fibromyalgia
Questionnaire characterizing the symptoms of those with fibromyalgia. The scale is composed of 3 subscales; widespread pain index, symptom severity score A and B. The widespread pain index ranges from 0 to 19 with 19 indicating greater number of body areas in which pain was experienced. The symptom severity score A ranges from 0 to 9 with 9 indicating greater symptom severity. The symptom severity score B ranges from 0 to 3 with 3 indicating greater number of symptoms experienced. The total Symptom Severity Score is calculated by adding symptom severity score A and symptom severity score B with a total range of 0 (no symptoms) to 12 (great deal of symptoms).
Conditioned Pain Modulation
The difference in pressure pain (measured via pressure algometry) at the biceps and quadriceps with and without the subject's limb placed in an ice water bath.
Physical Activity Assessment Tool
The Physical Activity Assessment Tool estimates the amount of physical activity performed and perceptions towards participation in physical activity. The total amount of time per day (minutes/day) is calculated for time spent in moderate to vigorous physical activity. With 0 minutes indicating no time spent in moderate to vigorous physical activity and higher values indicating greater time spent in moderate to vigorous physical activity.
Total time spent in sedentary and moderate to vigorous physical activity measured by an Actigraph wGT3x over the course of 7 days.
An Actigraph wGT3x is a wrist worn device that is used to track the amount and intensity of physical activity performed over the course of seven days. Total time spent in sedentary and moderate to vigorous physical activity is measured in minutes.
Baseline Lean Mass
Measurement of lean mass with use of dual energy x-ray absorptiometry testing.
Baseline Fat Mass
Measurement of fat mass with use of dual energy x-ray absorptiometry testing.

Secondary Outcome Measures

Change from Baseline Maximal Voluntary Force to immediately after performance of exercise.
Maximal force produced with the arm when performing a bending motion of the elbow. Maximal torque is measured with an isokinetic dynamometer with higher levels indicating greater amount of force.
Baseline voluntary muscle activation of the biceps muscle
Assess each subject's ability to voluntarily activate their bicep muscle when performing a maximal voluntary contraction of the elbow flexors. Participants will generate maximal force from their elbow flexors with application of muscle stimulation. Muscle stimulation is provided via electrodes placed on the skin overlying the biceps muscle and activation of the muscle will be achieved by a constant-current stimulator. Force is recorded via isokinetic dynamometry. To assess voluntary activation, a single twitch will be interpolated during the plateau of the maximal voluntary contraction force by the stimulator.
Change from Baseline Heart Rate to immediately after performance of exercise.
Heart rate is measured with an automated cuff applied to the wrist.
Change from Baseline Blood Pressure to immediately after performance of exercise.
Blood pressure is measured with an automated cuff applied to the wrist.
Change from Baseline Rating of Perceived Exertion to immediately after performance of exercise
Rating of Perceived Exertion refers to the total amount of exertion a participant is feeling and measured with a modified BORG scale ranging from 0 (nothing) to 10 (maximal exertion).
Baseline sensory threshold assessed with von Frey monofilaments
Monofilaments will be applied perpendicular to the skin in ascending order, the lowest-size filament to induce sensation is recorded.
Change from baseline pain unpleasantness up to 7 days after exercise.
Unpleasantness in the exercising limb will be reported with a 0-10 numerical rating scale.
Change from baseline PROMIS Short Form v1.0 Pain Interference 6b up to 7 days after exercise.
A 6-item questionnaire will help measure interference of pain on functional daily activity.

Full Information

First Posted
December 12, 2018
Last Updated
June 6, 2022
Sponsor
Marquette University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT03778385
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 3, 2017 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marquette University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Exercise, Pain, Physical Activity, Body Composition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
Participant
Masking Description
Participants are masked to the primary hypothesis of the study.
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isometric Exercise
Arm Type
Experimental
Arm Description
Submaximal isometric resistance exercise of the arm.
Arm Title
Dynamic Exercise
Arm Type
Experimental
Arm Description
Submaximal dynamic resistance exercise of the arm.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Submaximal exercise is performed in randomized order with the participant seated and the arm supported in an adjustable hand-arm orthosis.
Primary Outcome Measure Information:
Title
Change from Baseline Short-Form McGill Pain Questionnaire to 7-days after performance of exercise.
Description
The Short-Form McGill Pain Questionnaire is a multi-dimensional tool to assess pain quality in chronic pain patients. Participants rate the intensity of pain and related symptoms they felt during the past week on 0 to 3 scale, with 0 being no pain and 3 being severe. The total score ranges from a minimum of 0 to maximum 45 with higher scores indicating worse symptoms.
Time Frame
Before and up to 7-days after performance of exercise.
Title
Change from Baseline Fibromyalgia Impact Questionnaire to 7-days after performance of exercise.
Description
The Fibromyalgia Impact Questionnaire - Revised measures function, overall impact, and symptoms of fibromyalgia. Participants rate the difficulty in performing daily tasks, the impact of their symptoms, and intensity of fibromyalgia symptoms on a 0 to 10 scale, with 10 signifying greater significance. The total score ranges from a minimum of 0 to maximum of 210 with higher scores indicating worse function and symptoms.
Time Frame
Before and up to 7-days after performance of exercise.
Title
Change from Baseline Pain Rating from a Pressure Pain Device to immediately after performance of exercise.
Description
Application of mechanical stimulus through a weighted Lucite edge will be applied to the finger for a maximal duration of 2 minutes. Subjects will provide a pain rating every 20 seconds during the 2-minute test. Pain ratings are provided with use of a Numerical Pain Rating Scale that ranges from 0 (no pain) to 10 (worst pain).
Time Frame
Before and immediately after performance of exercise.
Title
Change from Baseline Pressure Pain Threshold to immediately after performance of exercise.
Description
Application of a pressure stimulus is applied to the bicep muscle and quadriceps muscle at a rate of 50kPa per second until the pressure first becomes painful.
Time Frame
Before and immediately after exercise.
Title
Change from Baseline Numerical Pain Rating Scale to 7-days after performance of exercise.
Description
Pain in the exercising limb and whole body will be reported. Pain ratings are provided with use of a Numerical Pain Rating Scale that ranges from 0 (no pain) to 10 (worst pain).
Time Frame
Before, during, and up to 7-days after performance of exercise.
Title
Change in Pain Catastrophizing before to after exercise.
Description
Measures the exaggerated negative mental set brought to bear during an actual or anticipated painful experience. Measured with the Pain Catastrophizing Scale which has subscales of rumination, magnification, and helplessness. Rumination scale ranges from 0 to 16 with higher score indicating higher levels of rumination. Magnification scale ranges from 0 to 12 with higher scores indicating higher levels of magnification. Helplessness scale ranges from 0 to 24 with higher scores indicating higher levels of helplessness. The subscale scores are summed to compute a total score ranging from 0 to 52 with higher scores indicating higher levels of pain catastrophizing.
Time Frame
Through study completion, an average of 3 weeks.
Title
Baseline Tampa Scale of Kinesiophobia - 11
Description
Measures pain-related fear in relation to movement or avoidance type behaviors. A total score is computed ranging from 0 to 44 with higher scores indicating higher levels of pain-related fear.
Time Frame
At the beginning of each session.
Title
Change from Baseline PROMIS Short Form v1.0 - Fatigue 7a at completion of study.
Description
Measures the experience and impact of fatigue on daily activity. The PROMIS Short Form v1.0 - Fatigue 7a measures subjective feelings of tiredness to a sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Participants rank the level of tiredness on a scale of 1 (never) to 5 (always). The total score ranges from 7 to 35 with 35 indicating greater levels of exhaustion that impacts ability to perform daily tasks.
Time Frame
At the beginning of each exercise session.
Title
American College of Rheumatology Diagnostic Criteria for Fibromyalgia
Description
Questionnaire characterizing the symptoms of those with fibromyalgia. The scale is composed of 3 subscales; widespread pain index, symptom severity score A and B. The widespread pain index ranges from 0 to 19 with 19 indicating greater number of body areas in which pain was experienced. The symptom severity score A ranges from 0 to 9 with 9 indicating greater symptom severity. The symptom severity score B ranges from 0 to 3 with 3 indicating greater number of symptoms experienced. The total Symptom Severity Score is calculated by adding symptom severity score A and symptom severity score B with a total range of 0 (no symptoms) to 12 (great deal of symptoms).
Time Frame
At the beginning of each session.
Title
Conditioned Pain Modulation
Description
The difference in pressure pain (measured via pressure algometry) at the biceps and quadriceps with and without the subject's limb placed in an ice water bath.
Time Frame
Day 1 of enrollment
Title
Physical Activity Assessment Tool
Description
The Physical Activity Assessment Tool estimates the amount of physical activity performed and perceptions towards participation in physical activity. The total amount of time per day (minutes/day) is calculated for time spent in moderate to vigorous physical activity. With 0 minutes indicating no time spent in moderate to vigorous physical activity and higher values indicating greater time spent in moderate to vigorous physical activity.
Time Frame
Up to 7 days.
Title
Total time spent in sedentary and moderate to vigorous physical activity measured by an Actigraph wGT3x over the course of 7 days.
Description
An Actigraph wGT3x is a wrist worn device that is used to track the amount and intensity of physical activity performed over the course of seven days. Total time spent in sedentary and moderate to vigorous physical activity is measured in minutes.
Time Frame
Worn continuously for a 7-day period during study enrollment.
Title
Baseline Lean Mass
Description
Measurement of lean mass with use of dual energy x-ray absorptiometry testing.
Time Frame
7 to 14 days after enrollment.
Title
Baseline Fat Mass
Description
Measurement of fat mass with use of dual energy x-ray absorptiometry testing.
Time Frame
7 to 14 days after enrollment.
Secondary Outcome Measure Information:
Title
Change from Baseline Maximal Voluntary Force to immediately after performance of exercise.
Description
Maximal force produced with the arm when performing a bending motion of the elbow. Maximal torque is measured with an isokinetic dynamometer with higher levels indicating greater amount of force.
Time Frame
Before and immediately after performance of exercise.
Title
Baseline voluntary muscle activation of the biceps muscle
Description
Assess each subject's ability to voluntarily activate their bicep muscle when performing a maximal voluntary contraction of the elbow flexors. Participants will generate maximal force from their elbow flexors with application of muscle stimulation. Muscle stimulation is provided via electrodes placed on the skin overlying the biceps muscle and activation of the muscle will be achieved by a constant-current stimulator. Force is recorded via isokinetic dynamometry. To assess voluntary activation, a single twitch will be interpolated during the plateau of the maximal voluntary contraction force by the stimulator.
Time Frame
Through study completion, an average of 3 weeks.
Title
Change from Baseline Heart Rate to immediately after performance of exercise.
Description
Heart rate is measured with an automated cuff applied to the wrist.
Time Frame
Measured before, during, and immediately after exercise.
Title
Change from Baseline Blood Pressure to immediately after performance of exercise.
Description
Blood pressure is measured with an automated cuff applied to the wrist.
Time Frame
Measured before, during, and immediately after exercise.
Title
Change from Baseline Rating of Perceived Exertion to immediately after performance of exercise
Description
Rating of Perceived Exertion refers to the total amount of exertion a participant is feeling and measured with a modified BORG scale ranging from 0 (nothing) to 10 (maximal exertion).
Time Frame
Measured before, during, and immediately after exercise.
Title
Baseline sensory threshold assessed with von Frey monofilaments
Description
Monofilaments will be applied perpendicular to the skin in ascending order, the lowest-size filament to induce sensation is recorded.
Time Frame
At the beginning of each session.
Title
Change from baseline pain unpleasantness up to 7 days after exercise.
Description
Unpleasantness in the exercising limb will be reported with a 0-10 numerical rating scale.
Time Frame
Before, during, and up to 7-days after performance of exercise.
Title
Change from baseline PROMIS Short Form v1.0 Pain Interference 6b up to 7 days after exercise.
Description
A 6-item questionnaire will help measure interference of pain on functional daily activity.
Time Frame
Before, during, and up to 7-days after performance of exercise.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie K Hoeger Bement, PT, PhD
Organizational Affiliation
Marquette University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marquette University
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Influence of Exercise Type, Pain Mechanisms, and Biopsychosocial Contributions to Pain Relief in Those With Fibromyalgia

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