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

NCT07242573 | Recruiting

• 1 other identifier: NIGRR
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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. 1.Physical training + conventional physiotherapy,
2. 2.Transcutaneous neuromodulation + conventional physiotherapy,
3. 3.Control (conventional physiotherapy only). The results will support the development of evidence-based rehabilitation protocols for fibromyalgia patients.

Conditions

Fibromyalgia; Chronic Fatigue Syndrome (CFS)

Keywords

Fibromyalgia; Rehabilitation; Sleep Quality; Pain Management; Exercise Therapy; NESA X-Signal; Transcutaneous Electrical Stimulation; Neuromodulation; Physiotherapy; Physical Training; Chronic Fatigue Syndrome

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (4)

• Change in depressive symptoms (Beck Depression Inventory - BDI)

  Baseline to 6 weeks

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

  Baseline to 6 weeks

• Change in fatigue severity (Fatigue Severity Scale - FSS)

  Baseline to 6 weeks

• Change in fatigue impact (Fatigue Impact Scale - FIS)

  Baseline to 6 weeks

Study Arms (3)

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.

Other: Physical Training Program

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.

Device: NESA X-Signal

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.

Other: Conventional Physiotherapy

Interventions

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.

1. Physical Training Group

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.

2. Neuromodulation Group

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.

3. Control Group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland: lead

Study Sites (1)

Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR)

Warsaw, Masovian Voivodeship, 02-637, Poland

RECRUITING

MeSH Terms

Conditions

Fibromyalgia; Fatigue Syndrome, Chronic; Sleep Initiation and Maintenance Disorders; Agnosia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms

Study Officials

• 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

  STUDY CHAIR

• Filip Królikowski, MSc, Physiotherapist

  Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR), Warsaw, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Filip Królikowski, MSc, Physiotherapist

CONTACT

226709161; Filip.krolikowski@spartanska.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): February 20, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

PL (1)