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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

Study 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

Primary outcome measure(s)

• Change in pain intensity (Visual Analogue Scale - VAS 0-10) — Baseline to 6 weeks (post-intervention)
  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) — Baseline to 6 weeks (post-intervention)
  Change in PSQI global score from baseline to post-intervention across study arms.

Trial sites (1)

More National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland trials in Poland