Investigation of the Relationship Between Central Sensitization and Balance in Fibromyalgia

Официальное название

Investigation of the Relationship Between Central Sensitization Parameters and Balance Changes in Patients With Fibromyalgia

Обзор

The aim of the study is to investigate the relationship between central sensitization parameters and changes in static and dynamic balance in patients with fibromyalgia. The main questions it aims to answer are: * Do central sensitization parameters differ in patients with fibromyalgia compared to healthy individuals? * How is balance performance in these individuals compared to healthy controls? * Do central sensitization parameters affect static and dynamic balance in patients with fibromyalgia? * Do central sensitization parameters lead to quantitative changes in balance in patients with fibromyalgia?

Подробное описание

Fibromyalgia is a syndrome characterized by chronic and widespread musculoskeletal pain. It is often accompanied by other symptoms such as fatigue, bowel disorders, sleep disturbances, and mood changes. It is estimated that fibromyalgia syndrome (FMS) affects approximately 2% to 8% of the global population.

The American College of Rheumatology (ACR) diagnostic criteria, based on the presence of multiple tender points, widespread chronic pain, somatic symptoms (such as headaches and abdominal pain), and cognitive symptoms, are used to diagnose individuals with fibromyalgia syndrome (FMS). Widespread pain, headaches, muscle spasms, and balance disorders are the most common symptoms leading to physical disability. These disabling symptoms reduce quality of life and make daily activities more difficult. The impact of these symptoms results in an annual cost of €7,256-7,900 per diagnosed patient in developed countries, creating a secondary socioeconomic burden . This burden includes high absenteeism, unemployment, early retirement, and an increased number of sick leave days.

Postural stability is a complex task required to maintain balance and orientation in a gravity-based environment. This task necessitates the rapid and dynamic integration of sensory information from the somatosensory, vestibular, and visual systems, which are essential for maintaining balance. Changes in balance are associated with poor balance confidence, which increases the risk of falls. Balance disorders are among the most common symptoms in patients with fibromyalgia syndrome (FMS), with a prevalence ranging from 45% to 68%. Previous studies have demonstrated that balance disorders are more prevalent in FMS patients compared to healthy individuals. Furthermore, in FMS patients with impaired balance, a correlation has been shown between balance disorders and an increased risk and/or frequency of falls. However, the underlying mechanism of balance problems in these patients has not yet been elucidated.

FMS is known to originate from a central sensitization phenomenon. According to the International Association for the Study of Pain, central sensitization is defined as an increased response of central nervous system (CNS) neurons to normal or subthreshold afferent inputs. It is hypothesized that changes in postural control may be a response to impaired sensory processing within the CNS and that the increased responsiveness of nociceptive neurons and the presence of central sensitization in the CNS may affect postural control processing, altering neuromuscular interactions and disrupting balance.

Central sensitization, one of the key mechanisms in the pathogenesis of FMS, has been reported to play a significant role in balance control in a study conducted by Sennholz et al. on patients with migraines. In this study, which included migraine patients and healthy controls, balance assessment was performed alongside an evaluation of central sensitization using quantitative sensory tests (cold and heat pain thresholds, mechanical pain thresholds, and pressure pain thresholds) and the central sensitization inventory. The results demonstrated that balance impairment in migraine patients was associated with a decreased pain threshold and an increased central sensitization inventory score.

To our knowledge, no study has yet quantitatively investigated the relationship between central sensitization levels and balance performance in FMS. Based on these findings, we aim to determine the relationship between central sensitization parameters and static and dynamic balance changes in FMS, a member of the central sensitivity syndrome family, similar to migraines. Furthermore, we seek to highlight the importance of future rehabilitation interventions targeting this relationship, thereby contributing to the existing literature.

The study will be conducted as an observational, single-center study at the Physical Medicine and Rehabilitation Clinic of Health Sciences University Sultan 2.Abdülhamid Han Training and Research Hospital, involving patients diagnosed with FMS and healthy volunteers.

As part of the study, demographic data including participants' age, gender, height, weight, body mass index, smoking and alcohol use, marital status, occupation, education level, current medications, presence of comorbidities, and duration of FMS diagnosis will be recorded. Patients will be evaluated once, and the assessment will consist of the following:

* Biodex Balance System \[Biodex Balance System SD (Biodex, Inc, Shirley, NY) (BBS)\] * Quantitative Sensory Testing, including Pressure Pain Threshold Measurement with an Algometer and Conditioned Pain Modulation * Slowly Repeated Evoked Pain Assessment Protocol * Central Sensitization Inventory * Numeric Rating Scale * Revised Fibromyalgia Impact Questionnaire * S-LANSS Pain Score * Tampa Kinesiophobia Scale * Hospital Anxiety and Depression Scale * SF-12 Quality of Life Scale * Fatigue Severity Scale * Timed Up and Go Test

Number of Patients to be Included in the Study:The number of patients to be included in the study has been planned based on the study by Sennholz et al., published in May 2024, using G-power version 3.1. The study will include 20 healthy controls and 55 fibromyalgia patients.

Statistical Methods:The distribution pattern of the data and the tests to be applied will be determined based on the Kolmogorov-Smirnov test, skewness, and kurtosis values. If the data follow a parametric distribution, they will be presented as mean ± standard deviation and 95% confidence interval; if the data follow a non-parametric distribution, they will be presented as median ± interquartile range (IQR).

Pressure pain threshold measurements with the algometer, conditioned pain modulation measurements, slowly repeated evoked pain measurements, and balance parameters will be compared between the patient and control groups using independent group T-tests or Mann-Whitney U tests. The linear relationships between algometer pressure pain threshold measurements, conditioned pain modulation, slowly repeated evoked pain measurements, and clinical parameters will be examined using Spearman/Pearson correlation analysis. For parametric data, multiple regression models may be constructed based on the characteristics of the variables.

Вмешательства

• Диагностический тест Biodex Balance System
  Biodex Balance System \[Biodex Balance System SD (Biodex, Inc, Shirley, NY) (BBS)\]:The Biodex Balance System is a computer-assisted device that assesses postural stability. It measures static and dynamic balance, fall risk, and proprioception through different difficulty levels and test protocols. In our study, this system will be used to investigate the relationship between balance and central sensitization. Participants will be evaluated using the postural stability test, fall risk test, athl
• Диагностический тест Pressure Pain Threshold (PPT) Measurement with Algometer
  Pressure pain threshold (PPT) is defined as the minimum force applied that causes pain. This measurement is commonly used for assessing tender points and has been shown to be useful.
• Диагностический тест Conditioned Pain Modulation (CPM)
  According to this protocol, a pressure stimulus, referred to as the test stimulus, will first be applied to the trapezius muscle to induce a pain intensity of 4 on a 10-point Numeric Rating Scale (NRS). Subsequently, a conditioning stimulus will be introduced by immersing the participant's right hand in 7°C water for 20 seconds. Following this conditioning stimulus, the same test stimulus will be reapplied to the trapezius muscle, and participants will be asked to rate their pain using the NRS.
• Диагностический тест Slowly Repeated Evoked Pain Assessment Protocol (SREP)
  Responses to induced pain indicate the presence of allodynia and hyperalgesia in FMS patients. The Slow Repetitive Evoked Pain (SREP) protocol consists of nine suprathreshold painful stimuli applied to the nail bed for five seconds each, with 30-second intervals. Painful stimulation will be administered using a pressure algometer with a 1 cm² stimulation surface. Nailbed pain stimuli are commonly used to assess pain sensitivity. The intensity of pain perception from each SREP stimulus will be e
• Диагностический тест Central Sensitization Inventory (CSI)
  The Central Sensitization Inventory (CSI) is used by some researchers to investigate pain sensitivity through symptoms associated with central sensitization and related comorbidities. It can help determine the severity of central sensitization. The scale was developed to detect central sensitization in patients with chronic pain and consists of two sections: Section A and Section B. For scoring purposes, only Section A is used. A score of 40 or higher out of 100 is associated with an increased
• Диагностический тест Numeric Rating Scale (NRS)
  Numeric Rating Scale (NRS) will be used to determine pain intensity during assessments. Participants will be asked to rate their pain intensity by selecting a value between 0 and 10. Higher scores are associated with increased pain severity.
• Диагностический тест Revised Fibromyalgia Impact Questionnaire (FIQ)
  Revised Fibromyalgia Impact Questionnaire (FIQ) consists of three sections: function, general, and symptoms, with a total of 21 questions. It evaluates the limitations and functional disability that occur in patients with fibromyalgia. All questions are scored on the Numeric Rating Scale (NRS), ranging from 0 to 10. As the score from the questionnaire increases, it indicates a higher level of disability related to fibromyalgia. In our study, the Turkish version of the questionnaire, which has be
• Диагностический тест S-LANSS Pain Score (Self-administered Leeds Assessment of Neuropathic Symptoms and Signs)
  The S-LANSS pain score is a 7-item self-administered scale developed and validated to recognize neuropathic pain in chronic pain patients and distinguish it from nociceptive pain. It evaluates neuropathic symptoms and signs through a series of questions that help identify features like hyperalgesia, allodynia, and paresthesia, which characterize the chronic pain sensation associated with neuropathic pain. These features are often seen in fibromyalgia (FMS) pain. In our study, the Turkish version
• Диагностический тест Tampa Kinesiophobia Scale (TKS)
  The Tampa Kinesiophobia Scale is a 17-item measure designed to assess fear of movement/re-injury. The scale evaluates fear-avoidance behaviors related to work activities, injury/re-injury concerns, and fear-avoidance parameters. It is used in the context of acute and chronic low back pain, fibromyalgia (FMS), musculoskeletal injuries, and whiplash-associated disorders. The scale uses a 4-point Likert scoring system (1 = Strongly disagree, 4 = Strongly agree). After reversing the scores for item
• Диагностический тест Hospital Anxiety and Depression Scale (HAD)
  This scale is used to assess anxiety and depression symptoms and consists of 14 items (7 items for anxiety, 7 items for depression). For each subscale, scores range from 0 to 21: * 0-7 points: No symptoms or very mild symptoms * 8-10 points: Moderate symptoms * 11 points or higher: Symptoms likely corresponding to a clinical diagnosis of anxiety and depression According to the 2016 diagnostic criteria for Fibromyalgia Syndrome (FMS), the presence of depression contributes to the diagnosis of FM

Первичные конечные точки

• Pressure Pain Threshold (PPT) Measurement with Algometer [Срок оценки: 5 months]
• Conditioned Pain Modulation (CPM) [Срок оценки: 5 months]
• Slowly Repeated Evoked Pain Assessment Protocol (SREP) [Срок оценки: 5 months]

Вторичные конечные точки (10)

• Biodex Balance System [Срок оценки: 5 months]
• The Central Sensitization Inventory (CSI) [Срок оценки: 5 months]
• Numeric Rating Scale (NRS) [Срок оценки: 5 months]
• Revised Fibromyalgia Impact Questionnaire (FIQ) [Срок оценки: 5 months]
• S-LANSS Pain Score (Self-administered Leeds Assessment of Neuropathic Symptoms and Signs) [Срок оценки: 5 months]
• Tampa Kinesiophobia Scale (TKS) [Срок оценки: 5 months]
• Hospital Anxiety and Depression Scale (HAD) [Срок оценки: 5 months]
• SF-12 Health Survey (SF-12 Quality of Life Scale) [Срок оценки: 5 months]
• The Fatigue Severity Scale (FSS) [Срок оценки: 5 months]
• The Timed Up and Go (TUG) [Срок оценки: 5 months]

Критерии участия

Критерии включения

• Diagnosis of FMS according to the ACR 2016 diagnostic criteria
• Being between the ages of 18 and 65
• Being literate
• Providing informed consent by signing the voluntary consent form

Критерии исключения

• Being under 18 years old or over 65 years old
• Presence of vestibular disorders
• Having undergone spinal and/or extremity surgery (such as for back/hip/knee/foot) within the last 6 months
• History of lower extremity amputation
• Presence of spinal deformities
• Peripheral arterial disease
• Vitamin B12 deficiency
• Any neurological disorder (e.g., stroke, traumatic brain injury, multiple sclerosis, Parkinson's disease, central nervous system malignancies, etc.)
• Severe cardiopulmonary insufficiency (stage 3-4)
• Uncontrolled systemic diseases such as hypertension and diabetes
• Presence of systemic inflammatory diseases, malignancies, or active infections
• Pregnancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Turkey (Türkiye) · 1 центр

• Sultan 2. Abdülhamid Han Training and Research Hospital, İstanbul, Üsküdar — Istanbul

Идентификаторы

NCT: NCT06851091 · 24/759

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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