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

NCT03778385 | Unknown DMC

• 4 other identifiers: HR-3035R15HD090265TL1TR001437UL1TR001436
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Exercise; Pain; Physical Activity; Body Composition

Outcome Measures

Primary Outcomes (14)

• 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.

  Before and up to 7-days after performance of exercise.

• 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.

  Before and up to 7-days after performance of exercise.

• 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).

  Before and immediately after performance of exercise.

• 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.

  Before and immediately after exercise.

• 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).

  Before, during, and up to 7-days after performance of exercise.

• 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.

  Through study completion, an average of 3 weeks.

• 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.

  At the beginning of each session.

• 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.

  At the beginning of each exercise session.

• 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).

  At the beginning of each session.

• 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.

  Day 1 of enrollment

• 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.

  Up to 7 days.

• 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.

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

• Baseline Lean Mass

  Measurement of lean mass with use of dual energy x-ray absorptiometry testing.

  7 to 14 days after enrollment.

• Baseline Fat Mass

  Measurement of fat mass with use of dual energy x-ray absorptiometry testing.

  7 to 14 days after enrollment.

Secondary Outcomes (8)

• Change from Baseline Maximal Voluntary Force to immediately after performance of exercise.

  Before and immediately after performance of exercise.

• Baseline voluntary muscle activation of the biceps muscle

  Through study completion, an average of 3 weeks.

• Change from Baseline Heart Rate to immediately after performance of exercise.

  Measured before, during, and immediately after exercise.

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

  Measured before, during, and immediately after exercise.

• Change from Baseline Rating of Perceived Exertion to immediately after performance of exercise

  Measured before, during, and immediately after exercise.

Study Arms (2)

Isometric Exercise

EXPERIMENTAL

Submaximal isometric resistance exercise of the arm.

Other: Exercise

Dynamic Exercise

EXPERIMENTAL

Submaximal dynamic resistance exercise of the arm.

Other: Exercise

Interventions

Exercise OTHER

Submaximal exercise is performed in randomized order with the participant seated and the arm supported in an adjustable hand-arm orthosis.

Dynamic Exercise; Isometric Exercise

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 (PAR-Q)
• English proficiency

You may not qualify if:

• 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

Sponsors & Collaborators

• Marquette University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Marquette University

Milwaukee, Wisconsin, 53233, United States

Location

Related Publications (1)

• Berardi G, Eble C, Hunter SK, Bement MH. Localized Pain and Fatigue During Recovery From Submaximal Resistance Exercise in People With Fibromyalgia. Phys Ther. 2023 Jun 5;103(6):pzad033. doi: 10.1093/ptj/pzad033.

  PMID: 37384640 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Motor Activity; Pain

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Marie K Hoeger Bement, PT, PhD

  Marquette University

  PRINCIPAL INVESTIGATOR

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 exercise sessions. Clinical and experimental pain assessment will be performed before, during, and after each exercise task.

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 19, 2018
• Study Start: February 3, 2017
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: June 7, 2022

Record last verified: 2022-06

Locations

US (1)