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

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.

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.

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