Physical exercise and neuromodulation for fibromyalgia-related pain, sleep, and fatigue
Official title: Evaluation of the Effect of Individualized Physical Training and Neuromodulation on Pain, Sleep and Fatigue in Patients With Fibromyalgia: a Randomized Controlled Trial
Run by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland · NCT07242573 · Data updated 2026-11-12
This project will try structured treadmill/balance training or gentle transcutaneous neuromodulation, each combined with usual physiotherapy, to see if they reduce pain, improve sleep, and lower fatigue in adults with fibromyalgia and chronic fatigue.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years to 80 Years |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland Research network |
| Locations | 1 site (Warsaw, Masovian Voivodeship) |
| Status | Recruiting |
| Started | November 1, 2025 |
| Main results expected | February 20, 2027 |
| Study ends | December 15, 2027 |
| Registry record updated | February 24, 2026 |
| Trial ID | NCT07242573 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 20–80 with a confirmed diagnosis of fibromyalgia and chronic fatigue symptoms, stable medical status, sleep disturbances, and the ability to consent and attend a six-week rehabilitation program in Warsaw are ideal candidates.
✕Probably not a fit
Patients with excluded conditions such as implanted electronic devices (e.g., pacemaker), major neurological disorders, active cancer, infectious skin disease at stimulation sites, severe cognitive impairment, or who cannot communicate in Polish are unlikely to qualify or benefit from these interventions.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Seventy-five adults with confirmed fibromyalgia and chronic fatigue symptoms are randomized at a Warsaw rehabilitation center into three groups: structured physical training using a Zebris treadmill and Alfa balance platform plus conventional physiotherapy, transcutaneous neuromodulation (NESA X-Signal) plus conventional physiotherapy, or conventional physiotherapy alone. Interventions last six weeks and are supervised by a multidisciplinary rehabilitation team. Outcomes include pain scales (VAS, WPI, SSS), fatigue measures (FSS, FIS), sleep quality (PSQI), depressive symptoms (Beck Depression Scale), and functional mobility tests. Data will be analyzed for within- and between-group changes to inform evidence-based rehabilitation protocols for fibromyalgia.
Why it matters
Potential benefit: If successful, the combined exercise or neuromodulation programs could reduce pain and fatigue and improve sleep and daily function for people with fibromyalgia.
How similar studies have gone: Structured exercise programs have shown benefit for fibromyalgia in prior research, while transcutaneous neuromodulation approaches like NESA X-Signal remain less established with mixed or preliminary results.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR)
Warsaw, Masovian Voivodeship, Poland Recruiting
Study contacts
- Principal investigator: Filip Królikowski, MSc, Physiotherapist — Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR), Warsaw, Poland
- Study coordinator: Filip Królikowski, MSc, Physiotherapist
- Email: Filip.krolikowski@spartanska.pl
- Phone: 226709161
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.