Actively Recruiting

Phase Not Applicable
Age: 20Years - 80Years
All Genders
NCT07242573

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

Led by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland · Updated on 2026-02-24

75

Participants Needed

1

Research Sites

110 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 20Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Lack of informed consent or cooperation
  • Refusal to undergo procedures beyond standard NFZ physiotherapy
  • Cancer
  • Neurological disorders such as neuralgia, multiple sclerosis, diabetic polyneuropathy, or stroke
  • Diagnosed dementia or cognitive impairment
  • Implanted electronic devices such as pacemaker
  • Internal bleeding or acute febrile illness
  • Acute thrombophlebitis
  • Hysteria or electric phobia
  • Neurotic addiction to stimulation
  • Infectious skin diseases such as mycosis or purulent dermatitis
  • Inability to communicate in Polish sufficiently to complete questionnaires or follow instructions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Warsaw, Masovian Voivodeship, Poland, 02-637

Actively Recruiting

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Research Team

F

Filip Królikowski, MSc, Physiotherapist

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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