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

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Poland
Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR)
RECRUITING
Warsaw
Contact Information
Primary
Filip Królikowski, MSc, Physiotherapist
Filip.krolikowski@spartanska.pl
226709161
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2027-12-15
Participants
Target number of participants: 75
Treatments
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.
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.
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.
Related Therapeutic Areas
Sponsors
Leads: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

This content was sourced from clinicaltrials.gov