Effect of Physical Exercise and Neuromodulation on Pain, Sleep and Fatigue in Patients With Fibromyalgia
Evaluation of the Effect of Individualized Physical Training and Neuromodulation on Pain, Sleep and Fatigue in Patients With Fibromyalgia: a Randomized Controlled Trial
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
75 participants
Nov 1, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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
Exclusion Criteria12
- 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
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Interventions
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.
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.
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.
Locations(1)
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NCT07242573