The Effect of Repetitive Transcranial Magnetic Stimulation on Symptoms and Gait in Patients With Primary Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in dual-task gait parameters from baseline to post-treatment
研究概览
简要总结
Fibromyalgia is a chronic condition that causes widespread pain and is often accompanied by fatigue, poor sleep, mood symptoms, memory and concentration difficulties, and reduced quality of life. Many adults with fibromyalgia also experience limitations in daily physical functioning. These limitations may include slower or less stable walking, reduced walking endurance, and greater difficulty walking while performing another task at the same time, such as counting or carrying out a mental task.
This clinical study is designed to evaluate the effects of repetitive transcranial magnetic stimulation, also called rTMS, in adults with fibromyalgia. rTMS is a non-invasive brain stimulation technique that delivers magnetic pulses through the scalp to influence activity in specific brain areas involved in pain processing, mood regulation, and physical function. The procedure does not require surgery or anesthesia.
Participants in this study are randomly assigned to receive either real rTMS or sham rTMS. Sham rTMS is designed to look and feel similar to the real procedure but does not deliver active therapeutic brain stimulation. Comparing real and sham rTMS allows researchers to assess whether any observed improvements are related to the active treatment rather than to expectation or participation in the study.
The study evaluates whether real rTMS can improve symptoms and function in adults with fibromyalgia. Outcomes include pain, fatigue, mood, sleep, quality of life, cognition, and walking performance. Walking is assessed during usual walking and during dual-task walking, when participants walk while also performing another task. These assessments are used to better understand how fibromyalgia affects everyday functioning and whether rTMS may help improve both symptoms and objective physical performance.
The main hypothesis is that participants who receive real rTMS will show greater improvement than those who receive sham rTMS. It is expected that real rTMS may reduce pain and related symptoms, improve quality of life and cognitive or emotional functioning, and have a favorable effect on walking performance, especially under more demanding dual-task conditions.
详细描述
Fibromyalgia is a chronic pain condition characterized by widespread pain, fatigue, sleep problems, difficulties with memory and concentration, mood symptoms, and reduced quality of life. In addition to these symptoms, many adults with fibromyalgia also experience problems with physical functioning, balance, and walking. Walking is not only a physical activity but also requires attention, planning, and coordination between the brain and body. These demands become even greater when a person walks while performing another task at the same time, such as counting, thinking, or carrying an object. This is called dual-task walking and may reflect challenges that occur in everyday life.
Current drug treatments for fibromyalgia often provide only limited symptom relief and may sometimes affect cognition, balance, or physical functioning. For this reason, non-drug approaches are important in the management of fibromyalgia. Repetitive transcranial magnetic stimulation, or rTMS, is a non-invasive brain stimulation technique that uses magnetic pulses delivered through a coil placed on the scalp. These pulses can influence the activity of brain areas involved in pain processing, mood, attention, cognition, and movement control. The procedure does not require surgery or anesthesia.
This study will investigate the effects of rTMS applied over the left dorsolateral prefrontal cortex, a brain region involved in pain modulation, mood regulation, executive function, attention, and cognitive control of walking. The study is designed to evaluate whether real rTMS can improve walking performance and clinical symptoms in adults with fibromyalgia when compared with sham rTMS.
This will be a single-center, randomized, double-blind, sham-controlled clinical study conducted in adults with primary fibromyalgia. Participants will be adults with fibromyalgia whose diagnosis is confirmed according to established classification criteria. Eligible participants have chronic pain lasting more than three months, pain of at least moderate intensity, and persistent symptoms despite conventional pharmacological treatment. Participants are required to be right-handed and able to understand and sign the informed consent form.
People with other conditions that could explain widespread pain or significantly affect walking, balance, cognition, or safety are not included. These include unstable chronic diseases, inflammatory or autoimmune rheumatic diseases, significant degenerative musculoskeletal conditions affecting gait or balance, major psychiatric disorders, neurological disorders causing motor or cognitive deficits, pregnancy or breastfeeding, active infection, malignancy, high fracture risk, and standard safety contraindications to rTMS such as epilepsy, pacemakers, certain implants, metal in the head, or medicines that substantially lower the seizure threshold.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of fibromyalgia based on the revised 2016 American College of Rheumatology criteria.
- •A Visual Analogue Scale pain score of at least 4, with pain present for more than 3 months before inclusion in the study.
- •Pain resistant to standard analgesics, including paracetamol, nonsteroidal anti-inflammatory drugs, and low-potency opioids, administered at full therapeutic doses.
- •If receiving treatment for fibromyalgia, participants had to be on a stable dose for more than 1 month before inclusion in the study.
- •No previous treatment with repetitive transcranial magnetic stimulation.
排除标准
- •Inability to provide informed consent.
- •Other chronic conditions, diseases, or disorders that may cause diffuse pain, such as endocrine or metabolic diseases.
- •Other degenerative, orthopedic, or surgical diseases of the musculoskeletal system that significantly affect gait, including the use of crutches or a walking cane.
- •Presence of a chronic inflammatory rheumatic disease.
- •Presence of a systemic autoimmune disease.
- •Primary psychiatric diagnosis, including previously diagnosed severe depressive disorder, generalized anxiety disorder, or psychosis.
- •Psychoactive substance abuse.
- •Neurological diseases that have caused or may cause cognitive or motor deficits.
- •Specific conditions such as active infections, malignancy, osteoporosis with high fracture risk, fractures, and similar conditions.
- •Contraindications to repetitive transcranial magnetic stimulation, including epilepsy, central nervous system trauma, brain surgery, intracranial hemorrhage, implanted pacemaker or other metal implant, pregnancy, or breastfeeding.
结局指标
主要结局
Change in dual-task gait parameters from baseline to post-treatment
时间窗: Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.
The primary outcome is the between-group difference between active repetitive transcranial magnetic stimulation and sham stimulation in pre-post change in dual-task gait parameters. Gait was assessed using the GAITRite electronic walkway during dual-task walking conditions, including motor, mental, and combined motor-cognitive tasks. Spatiotemporal gait parameters included cycle time, stride length, swing time, double support time, and the coefficients of variation of these parameters. Changes were expressed as absolute delta values and relative percentage delta values from baseline to post-treatment.
次要结局
- Change in pain intensity from baseline to post-treatment(Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.)
- Change in pain severity and pain interference from baseline to post-treatment(Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.)
- Change in depressive symptoms from baseline to post-treatment(Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.)
- Change in anxiety symptoms from baseline to post-treatment(Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.)
- Change in sleep quality and sleep-related problems from baseline to post-treatment(Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.)
- Change in fatigue from baseline to post-treatment(Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.)
- Change in health-related quality of life from baseline to post-treatment(Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.)
- Change in cognitive function from baseline to post-treatment(Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.)
- Change in fibromyalgia impact from baseline to post-treatment(Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.)
- Incidence of adverse events during treatment(During the 10-session treatment protocol, approximately 2 weeks.)
研究者
Goran Radunovic
Prof. Goran Radunovic
Institute of Rheumatology, Serbia