Effect of Neuromodulation on Pain Biomarkers and Functional Outcome in Patients With Fibromyalgia Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pressure Pain Thresholds
研究概览
简要总结
Fibromyalgia is the third most common musculoskeletal condition in terms of prevalence, after lumbar pain and osteoarthritis. Its prevalence is around 2-4 % and is more frequent in women than in men; the prevalence is highest in age the range of 40-60 years.
详细描述
Group A (Control Group): Patients will receive exercises, and sham Non-Invasive Neuromodulation, 3 sessions per week (one hour for each session) for 4 weeks.
Group B (Study Group): Patients will receive exercises as in group (A) in addition to Non-Invasive Neuromodulation 3 sessions per week (one hour for each session) for 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients fibromyalgia from both genders.
- •The duration of fibromyalgia is more than 6 month (all patients with history of cervical or lumbar pain) and following diagnosis of FM using the 2016 revised FM criteria, on the basis of the ACR-2010 criteria.
- •Their ages will be ranged from 25-35 years old.
- •They will be medically stable and have sufficient cognitive abilities that enable them to understand and follow instruction according to Montreal Cognitive Assessment (MoCA) >26.
排除标准
- •Other Neurological diseases as stroke , multiple sclerosis, Parkinson's disease and motor neuron disease
- •Spinal fusion-cervical or lumbar
- •Metal implants in the spine
- •Severe psychiatric disorder or alcohol and drug abuse.
- •Unstable medical condition which could compromise the participant's welfare or confound the study results.
- •Uncontrolled blood pressure or diabetes
- •Visual or auditory problems.
- •Active inflammatory conditions
结局指标
主要结局
Pressure Pain Thresholds
时间窗: 4 weeks
Assess pain sensitivity through pressure algometer
Pain Numeric Pain Rating Scale
时间窗: 4 weeks
Assessment of pain intensity (0-no pain, 10-most intense pain)
Biochemical analysis
时间窗: 4 weeks
Assessment of pain intensity through the change of blood cortisol level, plasma cytokine level, antinuclear antibody (ANA) level. Blood samples will be taken between the hours of 08:00-09:00 in the morning. Two blood samples will be taken from the patients before and after treatment.
Fibromyalgia Impact Questionnaire
时间窗: 4 weeks
Assess functional outcome
次要结局
未报告次要终点
研究者
Ahmed Alshimy
Lecturer and Consultant in Physical Therapy at Department of Neurology and it's Surgery. Faculty of Physical Therapy Al Ryada University for Science and Technology, Egypt
AlRyada University for Science & Technology