FibromyalgiaNCT07242573
Effect of Physical Exercise and Neuromodulation on Pain, Sleep and Fatigue in Patients With Fibromyalgia
A study testing Physical Training Program, NESA X-Signal and Conventional Physiotherapy in people with Fibromyalgia and Chronic Fatigue Syndrome (CFS), run by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Fibromyalgia, Chronic Fatigue Syndrome (CFS)
- What is being tested?
- Physical Training Program, NESA X-Signal and Conventional Physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 sitePoland
- Study dates
- 1 Nov 2025to 15 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR)
Warsaw, Masovian Voivodeship, 02-637
Filip Królikowski, MSc, 22 670 91 61 ext. +48, Filip.krolikowski@spartanska.pl
About this study
Official title: 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:
- Physical training + conventional physiotherapy,
- Transcutaneous neuromodulation + conventional physiotherapy,
- Control (conventional physiotherapy only). The results will support the development of evidence-based rehabilitation protocols for fibromyalgia patients.
Read the 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.
- Conditions
- Fibromyalgia, Chronic Fatigue Syndrome (CFS)
- Being tested
- Physical Training Program, NESA X-Signal, Conventional Physiotherapy
- Keywords
- Fibromyalgia, Rehabilitation, Sleep Quality, Pain Management, Exercise Therapy, NESA X-Signal, Transcutaneous Electrical Stimulation, Neuromodulation, Physiotherapy, Physical Training, Chronic Fatigue Syndrome
- Medical subject headings
- Fibromyalgia, Fatigue Syndrome, Chronic, Sleep Initiation and Maintenance Disorders, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to 6 weeks (post-intervention)
Secondary outcomes (4)
Change in depressive symptoms (Beck Depression Inventory - BDI)
Change in BDI total score from baseline to post-intervention.
Measured: 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.
Measured: Baseline to 6 weeks
Change in fatigue severity (Fatigue Severity Scale - FSS)
Change in FSS total score from baseline to post-intervention.
Measured: Baseline to 6 weeks
Change in fatigue impact (Fatigue Impact Scale - FIS)
Change in FIS total score assessing functional impact of fatigue.
Measured: Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Nov 2025
- Primary completion20 Feb 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Beata Tarnacka, Professor, MD, PhD, Study director, Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR), Warsaw, PolandJustyna Frasuńska, MD, PhD, Study chair, Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR), Warsaw, PolandFilip Królikowski, MSc, Physiotherapist, Principal investigator, Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR), Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242573
- Sponsor's protocol ID
- NIGRR
- Status last verified
- Feb 2026
- First submitted
- 17 Nov 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Individualized Physical Training and Neuromodulation on Pain, Sleep and Fatigue in Patients With Fibromyalgia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07242573
- Acronym / sponsor ID
- NIGRR
- Conditions
- Fibromyalgia, Chronic Fatigue Syndrome (CFS)
- Keywords
- Fibromyalgia, Rehabilitation, Sleep Quality, Pain Management, Exercise Therapy, NESA X-Signal, Transcutaneous Electrical Stimulation, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- National Institute of Geriatrics, Rheumatology and Rehabilitation, PolandResearch network
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 20 Feb 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Physical training + conventional physiotherapy,
- Transcutaneous neuromodulation + conventional physiotherapy,
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 1. Physical Training Group | Experimental | Other: Physical Training ProgramParticipants 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 | Device: NESA X-SignalParticipants 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 | Other: Conventional PhysiotherapyParticipants receive conventional physiotherapy only, including general exercise therapy, manual therapy, laser therapy, and relaxation sessions, consistent with standard clinical care for fibromyalgia patients. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 20 and 80 years
- Confirmed diagnosis of fibromyalgia
- Presence of chronic fatigue symptoms
- Stable health condition
- Presence of sleep disturbances
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Training ProgramStructured 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. | Other | 1. Physical Training Group |
| NESA X-SignalNon-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. | Device | 2. Neuromodulation Group |
| Conventional PhysiotherapyStandard 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. | Other | 3. Control Group |
Primary outcome
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.
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.
4 secondary outcomes
Change in depressive symptoms (Beck Depression Inventory - BDI)
Time frame: Baseline to 6 weeks
Change in Widespread Pain Index (WPI) and Symptom Severity Scale (SSS)
Time frame: Baseline to 6 weeks
Change in fatigue severity (Fatigue Severity Scale - FSS)
Time frame: Baseline to 6 weeks
Change in fatigue impact (Fatigue Impact Scale - FIS)
Time frame: Baseline to 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beata Tarnacka, Professor, MD, PhD study director
Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR), Warsaw, Poland
Justyna Frasuńska, MD, PhD study chair
Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR), Warsaw, Poland
Filip Królikowski, MSc, Physiotherapist principal investigator
Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR), Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Training Program, NESA X-Signal and Conventional Physiotherapy in people with Fibromyalgia and Chronic Fatigue Syndrome (CFS), run by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Filip Królikowski, MSc, Physiotherapist (226709161 ext. +48, Filip.krolikowski@spartanska.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity (Visual Analogue Scale - VAS 0-10) (time frame: Baseline to 6 weeks (post-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.