Effect of Physical Exercise and Neuromodulation on Pain, Sleep and Fatigue in Patients With Fibromyalgia: a Randomized Controlled Trial.
NCT ID: NCT07242573
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
75 participants
INTERVENTIONAL
2025-11-01
2027-12-15
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
1. Physical training using the Zebris treadmill and Alfa balance platform,
2. Transcutaneous neuromodulation with the NESA X-Signal device,
3. Control group with conventional physiotherapy only.
TREATMENT
NONE
Study Groups
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1. Physical Training Group
Participants receive a structured physical training program using the Zebris diagnostic treadmill and Alfa balance platform, combined with conventional physiotherapy. Sessions are conducted 5 times per week for 3 weeks and include aerobic, balance, and coordination exercises tailored individually to each patient.
Physical Training Program
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.
2. Neuromodulation Group
Participants undergo non-invasive transcutaneous neuromodulation (NESA X-Signal) combined with conventional physiotherapy. Sessions last 30 minutes and are performed 5 times per week for 3 weeks.
NESA X-Signal
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.
3. Control Group
Participants receive conventional physiotherapy only, including general exercise therapy, manual therapy, laser therapy, and relaxation sessions, consistent with standard clinical care for fibromyalgia patients.
Conventional Physiotherapy
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.
Interventions
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Physical Training Program
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
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
80 Years
ALL
No
Sponsors
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National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
NETWORK
Responsible Party
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Principal Investigators
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Beata Tarnacka, Professor, MD, PhD
Role: STUDY_DIRECTOR
Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR), Warsaw, Poland
Justyna Frasuńska, MD, PhD
Role: STUDY_CHAIR
Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR), Warsaw, Poland
Filip Królikowski, MSc, Physiotherapist
Role: PRINCIPAL_INVESTIGATOR
Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR), Warsaw, Poland
Locations
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Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR)
Warsaw, Masovian Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NIGRR
Identifier Type: -
Identifier Source: org_study_id
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