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NCT Number: NCT07242573

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

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.

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Key information

Conditions

Fibromyalgia Agnosia Chronic Disease Chronic Fatigue Syndrome (CFS) Disease Attributes Dyssomnias Encephalomyelitis Fatigue Syndrome, Chronic Mental Disorders Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neuroinflammatory Diseases Neurologic Manifestations Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Rheumatic Diseases Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR)

Warsaw, Masovian Voivodeship, 02-637, Poland

Location status: Recruiting

Location contact

Filip Królikowski, MSc

CONTACT

[email protected]

22 670 91 61 ext. +48

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in pain intensity (Visual Analogue Scale - VAS 0-10)

    Time frame: 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.

  2. Change in sleep quality (Pittsburgh Sleep Quality Index - PSQI)

    Time frame: Baseline to 6 weeks (post-intervention)

    Change in PSQI global score from baseline to post-intervention across study arms.

Secondary outcomes

  1. Change in depressive symptoms (Beck Depression Inventory - BDI)

    Time frame: Baseline to 6 weeks

    Change in BDI total score from baseline to post-intervention.

  2. Change in Widespread Pain Index (WPI) and Symptom Severity Scale (SSS)

    Time frame: Baseline to 6 weeks

    Change in ACR diagnostic components (WPI and SSS) between baseline and post-intervention.

  3. Change in fatigue severity (Fatigue Severity Scale - FSS)

    Time frame: Baseline to 6 weeks

    Change in FSS total score from baseline to post-intervention.

  4. Change in fatigue impact (Fatigue Impact Scale - FIS)

    Time frame: Baseline to 6 weeks

    Change in FIS total score assessing functional impact of fatigue.

Study contacts

Contact information is provided by the study sponsor or research team.

Filip Królikowski, MSc, Physiotherapist

CONTACT

[email protected]

226709161 ext. +48

Sponsors and collaborators

Lead sponsor

National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

Network

Registry information

Official study title

Evaluation of the Effect of Individualized Physical Training and Neuromodulation on Pain, Sleep and Fatigue in Patients With Fibromyalgia: a Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 21, 2025
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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