Effect of Physical Exercise and Neuromodulation on Pain, Sleep and Fatigue in Patients With Fibromyalgia
RecruitingNot applicableNCT07242573
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Fibromyalgia
- Chronic Fatigue Syndrome (CFS)
- Interventions
- Other: Physical Training Program
- Device: NESA X-Signal
- Other: Conventional Physiotherapy
- Sponsor
- National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
- Start date
- 2025-11-01
- Primary completion
- 2027-02-20
- Sex
- All
- Age range
- from 20 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- Poland
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07242573