Evaluation of the Sural Nerve With Ultrasonography and Electromyography in Patients With Fibromyalgia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Fibromyalgia Impact Questionnaire (FEA)
研究概览
简要总结
By evaluating the ultrasonographic and electromyographic measurements of the sural nerve in patients with and without a diagnosis of fibromyalgia; to determine the relationship of these measures to each other and to the FIQ, neuropathic pain questionnaire-Clinical, single-blind, prospective, controlled study.
详细描述
In this study; the investigators will compare the results by evaluating the ultrasonographic and electromyographic measurements of the sural nerve between the groups and determine correlation of these results to each other and to the FIQ, neuropathic pain questionnaire in both groups.
Where the research will be conducted:
Kütahya Health Science Univercity Department of Physical Medicine and Rehabilitation Department The planned date range of the research: August 15 th 2021- December 2021 In the research; the investigators will include 55 participants who were diagnosed with fibromyalgia and 55 participants who were not diagnosed with fibromyalgia meeting the inclusion and exclusion criteria in Kütahya Health Sciences University Evliya Çelebi Training and Research Hospital between August 15 th 2021- December 2021, Participants without fibromiyalgia were planned as control group. All Participants will be asked about their age, gender, marital status, occupation, chronic diseases and previous surgeries, height-weight, smoking-alcohol use, when the diagnosis of fibromyalgia was and the drugs they used and also past operations.
This study is a single-blind, prospective study. The sural nerve electromyographic study, ultrasonographic measurement of the sural nerve, Fibromyalgia Impact Questionnaire and Neuropathic Pain Questionnaire will be applied by obtaining the consent of both groups.
Sample Selection: Computerized rondomized sample selection will be made. Statistical method to be used: The data to be obtained as a result of the study will be analyzed with the SPSS 20.0 statistical package program. Descriptive information will be given by calculating mean, frequency distributions, minimum, maximum, standard deviation, and percentage values. Whether there is a significant difference between the two groups by looking at the means will be evaluated with the independent student t test. The incidence of abnormal tests in EMG and US findings, and comparison of tests and examination findings will be made with the ANOVA test. Continuous variables will be given as mean±standard deviation and categorical variables as frequency and percentage. P values less than 0.05 will be considered statistically significant and the results will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Criteria for Inclusion in the Research:
- •over 18 years old,
- •Able to communicate in Turkish,
- •It was planned to consist of individuals who were literate and agreed to participate in the study among patients without psychiatric disease.
排除标准
- •Having a sensory defect or a disease that may cause sensory defect (DM, -Polyneuropathy, Parkinson's, Alzheimer's disease)
- •Kby, patients with uncontrollable hormonal abnormality
- •HIV, hcv, hbv, vasculitis, connective tissue disease
- •Patients who have undergone saphenous vein surgery
- •Patients who have received radiotherapy in the leg area
- •Patients with cardiac pacemaker
- •Patients undergoing treatment for malignancy and who have received kt that may lead to neuropathy
- •Having problems with reading and writing,communication problem
- •Those who are pregnant
- •Those who are deficient in B12 and other B group vitamins
结局指标
主要结局
Fibromyalgia Impact Questionnaire (FEA)
时间窗: 12 weeks
Functional status assessment will be evaluated with the Fibromyalgia Impact Questionnaire (FEA). The validity and reliability version of the questionnaire was done by Sarmer et al. made by (12). This scale; It measures 10 different features: physical function, well-being, not being able to go to work, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression. With the exception of the well-being trait, low scores indicate recovery or less affliction. The maximum score is 100. The average FM patient scores 50, while more severely affected FM patients usually score above 70.All patients with and without fibromyalgia diagnosis who participated in the study will fill out a questionnaire, and their relationship with each other will be evaluated by making ultrasonographic and electromyographic measurement evaluations of the sural nerve. there is no follow-up planned in the future as the study participants will not be administered.
次要结局
- Neuropathic pain questionnaire(12 weeks)
研究者
Aysun Ozlu
Principal Investigator
Kutahya Health Sciences University