Chronic Fatigue Syndrome (CFS), Fibromyalgia
Conditions
Keywords
Fibromyalgia, Rehabilitation, Sleep Quality, Pain Management, Exercise Therapy, NESA X-Signal, Transcutaneous Electrical Stimulation, Neuromodulation, Physiotherapy, Physical Training, Chronic Fatigue Syndrome
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.
Detailed description
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.
Interventions
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.
DEVICENESA 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.
OTHERConventional 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.
Sponsors
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants are randomly assigned to three parallel groups: 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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity (Visual Analogue Scale - VAS 0-10) | Baseline to 6 weeks (post-intervention) | 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. |
| Change in sleep quality (Pittsburgh Sleep Quality Index - PSQI) | Baseline to 6 weeks (post-intervention) | Change in PSQI global score from baseline to post-intervention across study arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in depressive symptoms (Beck Depression Inventory - BDI) | Baseline to 6 weeks | Change in BDI total score from baseline to post-intervention. |
| Change in Widespread Pain Index (WPI) and Symptom Severity Scale (SSS) | Baseline to 6 weeks | Change in ACR diagnostic components (WPI and SSS) between baseline and post-intervention. |
| Change in fatigue severity (Fatigue Severity Scale - FSS) | Baseline to 6 weeks | Change in FSS total score from baseline to post-intervention. |
| Change in fatigue impact (Fatigue Impact Scale - FIS) | Baseline to 6 weeks | Change in FIS total score assessing functional impact of fatigue. |
Countries
Poland
Contacts
CONTACTFilip Królikowski, MSc, Physiotherapist
STUDY_DIRECTORBeata Tarnacka, Professor, MD, PhD
Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR), Warsaw, Poland
STUDY_CHAIRJustyna Frasuńska, MD, PhD
Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR), Warsaw, Poland
PRINCIPAL_INVESTIGATORFilip Królikowski, MSc, Physiotherapist
Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR), Warsaw, Poland
Outcome results
None listed