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

NCT ID: NCT03778385

Last Updated: 2022-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-03
• Study Completion Date: 2023-01-31

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Isometric Exercise

Submaximal isometric resistance exercise of the arm.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

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

Dynamic Exercise

Submaximal dynamic resistance exercise of the arm.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

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

Interventions

Exercise

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

Marquette University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie K Hoeger Bement, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Marquette University

Locations

Marquette University

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37384640 (View on PubMed)

Other Identifiers

R15HD090265

Identifier Type: NIH

Identifier Source: secondary_id

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TL1TR001437

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UL1TR001436

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HR-3035

Identifier Type: -

Identifier Source: org_study_id