Effect of Physical Exercise and Neuromodulation on Pain, Sleep and Fatigue in Patients With Fibromyalgia

Официальное название

Evaluation of the Effect of Individualized Physical Training and Neuromodulation on Pain, Sleep and Fatigue in Patients With Fibromyalgia: a Randomized Controlled Trial

Обзор

Fibromyalgia (FMS) is a chronic, multifactorial syndrome characterized by widespread pain, fatigue, and cognitive disturbances. This interventional study evaluates the impact of structured physical training using diagnostic-training devices (Zebris treadmill and Alfa balance platform) and transcutaneous neuromodulation (NESA X-Signal) on pain, sleep quality, and overall health status in patients with fibromyalgia and chronic fatigue symptom. Participants are allocated into three groups: 1. Physical training + conventional physiotherapy, 2. Transcutaneous neuromodulation + conventional physiotherapy, 3. Control (conventional physiotherapy only). The results will support the development of evidence-based rehabilitation protocols for fibromyalgia patients.

Подробное описание

The study is conducted at the National Institute of Geriatrics, Rheumatology, and Rehabilitation (NIGRiR), Warsaw, Poland. It includes 75 patients aged 20-80 years with a confirmed diagnosis of fibromyalgia and chronic fatigue symptom. Participants are randomly assigned to one of three groups:

Group 1 receives structured physical training using the Zebris treadmill and Alfa balance platform, along with conventional physiotherapy.

Group 2 undergoes non-invasive transcutaneous neuromodulation (NESA X-Signal) and conventional physiotherapy.

Group 3 serves as a control group, receiving conventional physiotherapy only.

The interventions last 6 weeks, supervised by a multidisciplinary rehabilitation team. Clinical evaluations include pain intensity (VAS, WPI, SSS), fatigue (FSS, FIS), sleep quality (PSQI), depressive symptoms (Beck Depression Scale), and functional mobility assessments.

Data are analyzed statistically to compare within- and between-group differences. The study aims to determine the effectiveness of combined exercise and neuromodulation programs in improving physical and psychological well-being among fibromyalgia patients.

Вмешательства

• Другое Physical Training Program
  Structured physical training using Zebris diagnostic treadmill and Alfa balance platform, performed under physiotherapist supervision. Sessions are held 5 times per week for 3 weeks and include aerobic, balance, and coordination exercises tailored to individual patient needs.
• Устройство NESA X-Signal
  Non-invasive transcutaneous neuromodulation using the NESA X-Signal device. The device delivers microcurrent stimulation through gloves and socks electrodes (25 total) to modulate autonomic nervous system activity and reduce pain. Sessions last 30 minutes, performed 3 times per week for 6 weeks.
• Другое Conventional Physiotherapy
  Standard physiotherapy program consisting of general exercise therapy, relaxation and breathing training, manual therapy, and light physical modalities (e.g., laser, heat therapy). No neuromodulation or device-based interventions are applied.

Первичные конечные точки

• Change in pain intensity (Visual Analogue Scale - VAS 0-10) [Срок оценки: Baseline to 6 weeks (post-intervention)]
• Change in sleep quality (Pittsburgh Sleep Quality Index - PSQI) [Срок оценки: Baseline to 6 weeks (post-intervention)]

Вторичные конечные точки (4)

• Change in depressive symptoms (Beck Depression Inventory - BDI) [Срок оценки: Baseline to 6 weeks]
• Change in Widespread Pain Index (WPI) and Symptom Severity Scale (SSS) [Срок оценки: Baseline to 6 weeks]
• Change in fatigue severity (Fatigue Severity Scale - FSS) [Срок оценки: Baseline to 6 weeks]
• Change in fatigue impact (Fatigue Impact Scale - FIS) [Срок оценки: Baseline to 6 weeks]

Критерии участия

Критерии включения

• Age between 20 and 80 years
• Confirmed diagnosis of fibromyalgia
• Presence of chronic fatigue symptoms
• Stable health condition
• Presence of sleep disturbances
• Ability to provide written informed consent and cooperate during the study

Критерии исключения

• Lack of informed consent or cooperation
• Refusal to undergo procedures beyond standard NFZ physiotherapy
• Cancer
• Neurological disorders (e.g., neuralgia, multiple sclerosis, diabetic polyneuropathy, stroke)
• Diagnosed dementia or cognitive impairment
• Implanted electronic devices (e.g., pacemaker)
• Internal bleeding or acute febrile illness
• Acute thrombophlebitis
• Hysteria or electric phobia
• Neurotic addiction to stimulation
• Infectious skin diseases (e.g., mycosis, purulent dermatitis)
• Inability to communicate in Polish sufficiently to complete questionnaires or follow instructions

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Польша · 1 центр

• Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation ( — Warsaw

Идентификаторы

NCT: NCT07242573 · NIGRR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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