Effect of Physical Exercise and Neuromodulation on Pain, Sleep and Fatigue in Patients With Fibromyalgia
Recruiting · NCT07242573 · Interventional (participants receive a specific treatment) · Lead sponsor: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed.
- Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR) - Warsaw, Masovian Voivodeship, Poland