Evaluation of the Effect of Individualized Physical Training and Neuromodulation on Pain, Sleep and Fatigue in Patients With Fibromyalgia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in pain intensity (Visual Analogue Scale - VAS 0-10)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Lack of informed consent or cooperation
- •Refusal to undergo procedures beyond standard NFZ physiotherapy
- •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
研究组 & 干预措施
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.
干预措施: Physical Training Program (Other)
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.
干预措施: NESA X-Signal (Device)
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.
干预措施: Conventional Physiotherapy (Other)
结局指标
主要结局
Change in pain intensity (Visual Analogue Scale - VAS 0-10)
时间窗: 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)
时间窗: Baseline to 6 weeks (post-intervention)
Change in PSQI global score from baseline to post-intervention across study arms.
次要结局
- 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)