Effect of Physical Exercise and Neuromodulation on Pain, Sleep and Fatigue in Patients With Fibromyalgia

National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland75 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Interventions

Physical Training ProgramOTHER

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-SignalDEVICE

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 PhysiotherapyOTHER

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

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Baseline to 6 weeks (post-intervention)

Secondary Outcomes

Change in depressive symptoms (Beck Depression Inventory - BDI)

Change in BDI total score from baseline to post-intervention.

Time frame: Baseline to 6 weeks

Change in Widespread Pain Index (WPI) and Symptom Severity Scale (SSS)

Change in ACR diagnostic components (WPI and SSS) between baseline and post-intervention.

Time frame: Baseline to 6 weeks

Change in fatigue severity (Fatigue Severity Scale - FSS)

Change in FSS total score from baseline to post-intervention.

Time frame: Baseline to 6 weeks

Change in fatigue impact (Fatigue Impact Scale - FIS)

Change in FIS total score assessing functional impact of fatigue.

Time frame: Baseline to 6 weeks

Effect of Physical Exercise and Neuromodulation on Pain, Sleep and Fatigue in Patients With Fibromyalgia

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts