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

February 20, 2026 updated by: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

Evaluation of the Effect of Individualized Physical Training and Neuromodulation on Pain, Sleep and Fatigue in Patients With Fibromyalgia: a Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Poland
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-637
        • Recruiting
        • Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Other: 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.
Experimental: 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.
Device: 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.
Active Comparator: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in sleep quality (Pittsburgh Sleep Quality Index - PSQI)
Time Frame: Baseline to 6 weeks (post-intervention)
Change in PSQI global score from baseline to post-intervention across study arms.
Baseline to 6 weeks (post-intervention)
Change in pain intensity (Visual Analogue Scale - VAS 0-10)
Time Frame: 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.
Baseline to 6 weeks (post-intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in depressive symptoms (Beck Depression Inventory - BDI)
Time Frame: Baseline to 6 weeks
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)
Time Frame: Baseline to 6 weeks
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)
Time Frame: Baseline to 6 weeks
Change in FSS total score from baseline to post-intervention.
Baseline to 6 weeks
Change in fatigue impact (Fatigue Impact Scale - FIS)
Time Frame: Baseline to 6 weeks
Change in FIS total score assessing functional impact of fatigue.
Baseline to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Beata Tarnacka, Professor, MD, PhD, Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR), Warsaw, Poland
  • Study Chair: Justyna Frasuńska, MD, PhD, Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR), Warsaw, Poland
  • Principal Investigator: Filip Królikowski, MSc, Physiotherapist, Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR), Warsaw, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIGRR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fibromyalgia

Clinical Trials on Physical Training Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings