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

Sponsor
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Study ID
NCT07242573
Status
Recruiting
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Conditions

  • Chronic Fatigue Syndrome (CFS)
  • Fibromyalgia

Eligibility Criteria

Sex
ALL
Age
20 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Physical Training Program — OTHER
    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 — DEVICE
    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 — OTHER
    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 Details

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.

Key Dates

First listed
Nov 21, 2025
Start date
Nov 1, 2025
Status verified
Feb 2026
Primary completion
Feb 20, 2027
Completion
Dec 15, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1. Physical Training Group
    Participants receive a structured physical training program using the Zebris diagnostic treadmill and Alfa balance platform, combined with conventional physiotherapy. Sessions are conducted 5 times per week for 3 weeks and include aerobic, balance, and coordination exercises tailored individually to each patient.
  • Experimental: 2. Neuromodulation Group
    Participants undergo non-invasive transcutaneous neuromodulation (NESA X-Signal) combined with conventional physiotherapy. Sessions last 30 minutes and are performed 5 times per week for 3 weeks.
  • Active Comparator: 3. Control Group
    Participants receive conventional physiotherapy only, including general exercise therapy, manual therapy, laser therapy, and relaxation sessions, consistent with standard clinical care for fibromyalgia patients.

Primary Outcome Measure

Change in pain intensity (Visual Analogue Scale - VAS 0-10) [ Time Frame: Baseline to 6 weeks (post-intervention) ]

Central Contacts

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