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.
Age between 20 and 80 years
Confirmed diagnosis of fibromyalgia
Presence of chronic fatigue symptoms
Stable health condition
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)
Parallel
Physical Training Program
Other interventionStructured 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.
NESA X-Signal
DeviceNon-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.
Conventional Physiotherapy
Other interventionStandard 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.
Change in pain intensity (Visual Analogue Scale - VAS 0-10)
Difference in visual analogue scale, pain score between baseline and post-intervention across study arms. In which 0 means no pain, and 10 means excruciating pain.
Change in sleep quality (Pittsburgh Sleep Quality Index - PSQI)
Change in PSQI global score from baseline to post-intervention across study arms.
Change in depressive symptoms (Beck Depression Inventory - BDI)
Change in BDI total score from baseline to post-intervention.
Change in Widespread Pain Index (WPI) and Symptom Severity Scale (SSS)
Change in ACR diagnostic components (WPI and SSS) between baseline and post-intervention.
Change in fatigue severity (Fatigue Severity Scale - FSS)
Change in FSS total score from baseline to post-intervention.
Change in fatigue impact (Fatigue Impact Scale - FIS)
Change in FIS total score assessing functional impact of fatigue.
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