Effect of Physical Exercise and Neuromodulation on Pain, Sleep and Fatigue in Patients With Fibromyalgia: a Randomized Controlled Trial.

National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

Status: Enrolling

Conditions: Fibromyalgia; Chronic Fatigue Syndrome (CFS)

Treatments: Device: NESA X-Signal; Other: Physical Training Program; Other: Conventional Physiotherapy

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT07242573

NIGRR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

1. Physical Training Group

Experimental group

Description:

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.

Treatment:

Other: Physical Training Program

2. Neuromodulation Group

Experimental group

Description:

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.

Treatment:

Device: NESA X-Signal

3. Control Group

Active Comparator group

Description:

Participants receive conventional physiotherapy only, including general exercise therapy, manual therapy, laser therapy, and relaxation sessions, consistent with standard clinical care for fibromyalgia patients.

Treatment:

Other: Conventional Physiotherapy