NCT07242573 Effect of Physical Exercise and Neuromodulation on Pain, Sleep and Fatigue in Patients With Fibromyalgia
| NCT ID | NCT07242573 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland |
| Condition | Fibromyalgia |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2027-02-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 75 participants in total. It began in 2025-11-01 with a primary completion date of 2027-02-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Beata Tarnacka, Professor, MD, PhD
STUDY DIRECTOR
Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR), Warsaw, Poland
Frequently Asked Questions
Who can join the NCT07242573 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 80 Years, studying Fibromyalgia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07242573 currently recruiting?
Yes, NCT07242573 is actively recruiting participants. Contact the research team at Filip.krolikowski@spartanska.pl for enrollment information.
Where is the NCT07242573 trial being conducted?
This trial is being conducted at Warsaw, Poland.
Who is sponsoring the NCT07242573 clinical trial?
NCT07242573 is sponsored by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland. The principal investigator is Beata Tarnacka, Professor, MD, PhD at Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR), Warsaw, Poland. The trial plans to enroll 75 participants.
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