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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:
The study is conducted at the National Institute of Geriatrics, Rheumatology, and Rehabilitation (NIGRiR), Warsaw, Poland. It includes 75 patients aged 20-80 years with a confirmed diagnosis of fibromyalgia and chronic fatigue symptom. Participants are randomly assigned to one of three groups:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Physical Training Group | Experimental | 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. |
|
| 2. Neuromodulation Group | Experimental | 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. |
|
| 3. Control Group | Active Comparator | Participants receive conventional physiotherapy only, including general exercise therapy, manual therapy, laser therapy, and relaxation sessions, consistent with standard clinical care for fibromyalgia patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Training Program | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain intensity (Visual Analogue Scale - VAS 0-10) | Difference in visual analogue scale, pain score between baseline and post-intervention across study arms. In which 0 means no pain, and 10 means excruciating pain. | Baseline to 6 weeks (post-intervention) |
| Change in sleep quality (Pittsburgh Sleep Quality Index - PSQI) | Change in PSQI global score from baseline to post-intervention across study arms. | Baseline to 6 weeks (post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in depressive symptoms (Beck Depression Inventory - BDI) | Change in BDI total score from baseline to post-intervention. | Baseline to 6 weeks |
| Change in Widespread Pain Index (WPI) and Symptom Severity Scale (SSS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Filip Królikowski, MSc, Physiotherapist | Contact | 226709161 | +48 | Filip.krolikowski@spartanska.pl |
| Name | Affiliation | Role |
|---|---|---|
| Beata Tarnacka, Professor, MD, PhD | Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR), Warsaw, Poland | Study Director |
| Justyna Frasuńska, MD, PhD | Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR), Warsaw, Poland |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR) | Recruiting | Warsaw | Masovian Voivodeship | 02-637 | Poland |
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Participants are randomly assigned to three parallel groups:
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|
| NESA X-Signal | Device | 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 | Other | 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. |
|
Change in ACR diagnostic components (WPI and SSS) between baseline and post-intervention.
| Baseline to 6 weeks |
| Change in fatigue severity (Fatigue Severity Scale - FSS) | Change in FSS total score from baseline to post-intervention. | Baseline to 6 weeks |
| Change in fatigue impact (Fatigue Impact Scale - FIS) | Change in FIS total score assessing functional impact of fatigue. | Baseline to 6 weeks |
| Study Chair |
| Filip Królikowski, MSc, Physiotherapist | Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR), Warsaw, Poland | Principal Investigator |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D015673 | Fatigue Syndrome, Chronic |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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