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Comparison of Multidimensional Parameters in Women With Fibromyalgia and Healthy Controls

I

Izmir Democracy University

Status

Begins enrollment in 2 months

Conditions

Fibromyalgia
Chronic Widespread Pain

Treatments

Other: Clinical and Questionnaire-Based Assessment

Study type

Interventional

Funder types

Other

Identifiers

NCT07416097
Compass-35

Details and patient eligibility

About

Fibromyalgia (FM) is a chronic, widespread pain syndrome affecting 2-6.6% of the population and significantly impairing quality of life. In addition to pain, individuals with FM commonly experience fatigue, sleep disturbances, cognitive and psychological problems, leading to functional limitations and social difficulties. Central sensitization is considered a key mechanism, although the exact pathophysiology remains unclear, highlighting the need for multidimensional assessment.

FM affects not only physical function but also psychological status, autonomic nervous system regulation, sleep quality, self-esteem, eating behaviors, and gastrointestinal function. Depression, anxiety, autonomic dysfunction, sleep disorders, altered eating behaviors, and gastrointestinal symptoms are highly prevalent and closely associated with pain severity, fatigue, and reduced quality of life.

Given its complex biopsychosocial nature, FM requires a holistic evaluation and management approach. Accordingly, this study aims to compare symptoms, psychological status, autonomic function, sleep, eating behaviors, and gastrointestinal parameters between women with fibromyalgia and healthy women.

Full description

Fibromyalgia (FM) is a chronic and widespread pain syndrome affecting the musculoskeletal system. It affects approximately 2%-6.6% of the world population and is the second most common rheumatic disease worldwide. Fibromyalgia is a syndrome that seriously and negatively affects individuals' lives. Patients commonly experience pain, fatigue, sleep problems, morning stiffness, psychological problems, and impairments in cognitive functions. These symptoms lead to physical disabilities, decreased physical activity, and difficulties in career and social life. In this syndrome, symptoms may periodically remit, while at other times exacerbations may occur.

The pathophysiology of FM has not yet been clearly defined. Increased sensitivity of nociceptive neurons to normal or subthreshold afferent inputs, referred to as central sensitization, is thought to particularly explain the condition of individuals with FM. The uncertainty of fibromyalgia etiology, the wide variety of symptoms, and the individualized way in which it affects each person indicate that a multidimensional assessment is required.

Fibromyalgia is a complex syndrome that seriously and negatively affects not only pain and physical functions but also psychological status, sleep quality, autonomic functions, self-esteem, eating behaviors, and gastrointestinal symptoms. Depression and anxiety are among the most common problems in individuals with FM. In one study, while the prevalence of depression was approximately 39% and anxiety approximately 40% in individuals with chronic pain, these rates were reported as 54% for depression and 55% for anxiety in fibromyalgia. As the levels of depression and anxiety increase, individuals' functional status, symptoms, and quality of life are adversely affected (5). This demonstrates that treatment should not focus solely on physical aspects and pain, but that psychosocial conditions should also be addressed using a holistic approach.

Fibromyalgia is also associated with autonomic nervous system dysfunctions. Studies have shown that sympathetic nervous system activity is increased at rest in individuals with FM, while the stress response is diminished. In particular, orthostatic intolerance, tachycardia, gastrointestinal dysfunction, sweating disorders, and urinary symptoms have a higher prevalence in patients compared to healthy groups. In addition, these autonomic symptoms have been shown to be associated with pain severity, fatigue, and quality of life. These findings suggest that autonomic dysfunction is an important component of FM and that autonomic regulation strategies should be considered in symptom management.

Sleep problems are among the most common accompanying issues. Difficulties in falling asleep, sleep duration, sleep depth, sleep continuity, and sleep architecture disturbances are observed in 70-90% of patients. Excessive fatigue upon awakening in the morning is also common. Numerous studies have demonstrated the relationship between poor sleep quality and pain, fatigue, functional capacity, psychological status, and quality of life in fibromyalgia.

Self-esteem refers to an individual's balanced perspective toward themselves. It is a self-concept influenced by underlying disorders and their consequences, as well as by social support. Persistent pain, fatigue, functional limitations, decreased activities of daily living, and reduced quality of life experienced by individuals with FM significantly affect self-esteem, and this has been supported by various studies. Since self-esteem is associated with depression and anxiety in individuals with FM, it is considered one of the core components of the disease.

Eating behaviors are also affected in individuals with FM. Studies have shown that the prevalence of emotional, external, and restrained eating behaviors is higher in individuals with FM compared to healthy individuals and that these behaviors are associated with pain, depression, and anxiety. Eating behaviors are closely linked to the psychosocial components of FM and therefore require evaluation. However, there are a limited number of studies in the literature examining eating behaviors and eating disorders in individuals with FM.

Gastrointestinal (GI) symptoms are among the problems that significantly contribute to the multidimensional clinical presentation of the disease and are frequently encountered in individuals with FM. Complaints such as irritable bowel syndrome (IBS), abdominal pain, bloating, constipation, and diarrhea are commonly observed. These symptoms are thought to be associated with increased central sensitivity, visceral hypersensitivity, and gut microbiota imbalances seen in individuals with FM, and may exacerbate pain severity, fatigue, sleep disturbances, stress, and anxiety.

Fibromyalgia is a multifaceted syndrome in which physiological, psychological, and social components are affected together. Therefore, it is important to evaluate not only pain and physical symptoms but also psychological status, autonomic symptoms, sleep, self-esteem, eating behaviors, and gastrointestinal complaints collectively. The World Health Organization's definition of health as a state of physical, mental, and social well-being supports the need to address FM with a holistic approach. In this context, it is anticipated that our study will contribute to the literature by evaluating fibromyalgia from a multidisciplinary perspective. Therefore, the aim of our study is to compare symptoms, psychological status, autonomic function, sleep, eating behaviors, and gastrointestinal parameters between women with fibromyalgia and healthy women.

Enrollment

80 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Fibromyalgia Group

  • Female participants aged between 18 and 65 years
  • Admitted to the Physical Medicine and Rehabilitation Unit of Buca Seyfi Demirsoy Training and Research Hospital
  • Voluntary participation and provision of written informed consent
  • Clinical diagnosis of fibromyalgia according to the 2016 American College of Rheumatology (ACR) criteria

Healthy Control Group

  • Female participants aged between 18 and 65 years
  • Admitted to the Physical Medicine and Rehabilitation Unit of Buca Seyfi Demirsoy Training and Research Hospital
  • Voluntary participation and provision of written informed consent
  • No history or current diagnosis of chronic widespread pain, fibromyalgia, or any rheumatologic disease

Exclusion Criteria:

  • Severe reading or comprehension difficulties
  • Severe hearing impairment
  • Pregnancy
  • Presence of an active infection
  • Neurological or orthopedic conditions that limit mobility
  • Diagnosis of cancer
  • History of major surgery within the past 6 months
  • Presence of psychiatric or cognitive disorders that may interfere with study assessments

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Fibromyalgia Group
Other group
Description:
Patients diagnosed with fibromyalgia
Treatment:
Other: Clinical and Questionnaire-Based Assessment
Healty Group
Other group
Description:
Healthy women without fibromyalgia or other chronic pain conditions.
Treatment:
Other: Clinical and Questionnaire-Based Assessment

Trial contacts and locations

1

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Central trial contact

Beyzanur Beğenen Şavlı, Msc.Pt.; Betül Taşpınar, Prof.Dr.

Data sourced from clinicaltrials.gov

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