The Effect of Sympathetic Dysfunction on Muscle Spindle Activity in Patients With Fibromyalgia Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change from baseline in H-reflex amplitude after intervention
研究概览
简要总结
This study aims to reveal whether there is an impairment in the sympathetic regulation of muscle spindle sensitivity in patients with fibromyalgia syndrome (FMS).
详细描述
The common muscle pain and fatigue symptoms of FMS can be explained by impaired sympathetic regulation of muscle spindle sensitivity. The aim of this study is to reveal whether there is an impairment in the sympathetic regulation of muscle spindle sensitivity in FMS patients.
Material method:
In the first stage, resting sympathetic tone measurement and resting H-reflex and T-reflex recordings will be taken in all cases. Sympathetic tone measurement will be performed and H-reflex and T-reflex recordings will be taken during and after sympathetic stimulation maneuvers (mental arithmetic calculation and cold application) in FMS patients and healthy control subjects. In the second phase, the first dose of pregabalin will be given to patients diagnosed with FMS and prescribed pregabalin. Pregabalin is known to reduce sympathetic activity in FMS. After oral administration of pregabalin, its peak plasma concentration is reached in 0.9-1.3 hours. Therefore, 1.5 hours later, sympathetic tone measurement will be made at rest and during the sympathetic stimulation maneuver, and H-reflex and T-reflex recordings will be taken. Patients in the healthy control group will not be given pregabalin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
盲法说明
In order to ensure that the researcher who took the recordings is blind, sympathetic tone measurement will be made at rest and during the sympathetic stimulation maneuver in healthy subjects 1.5 hours later, and H-reflex and T-reflex recordings will be taken.
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •For the fibromyalgia group
- •Patients diagnosed with FMS based on the American college of rheumatology - 2016 criteria
- •Between the ages of 20-50
- •Being a woman
- •Patients prescribed pregabalin for the treatment
- •For the Healthy Control group
- •Between the ages of 20-50
- •Being a woman
- •Being healthy
排除标准
- •Those with medical problems in the right upper and lower extremities (skin, neuromuscular, joint, vascular pathologies)
- •Cases that cannot perform arithmetic operations
- •Cold allergy
- •Heart disease (arrhythmia, ischemic heart disease, heart failure)
- •Hypertension
研究组 & 干预措施
Fibromyalgia group
In the first phase of the experiment, the effect of sympathetic tone change on T- and H-reflexes will be evaluated.
In the second phase of the experiment, 150 mg (single dose) of pregabalin will be given to these patients to reduce sympathetic activity and evaluate its effect on T- and H-reflexes.
干预措施: sympathetic stimulation maneuver (mental arithmetic test, cold pressure test) (Diagnostic Test)
Fibromyalgia group
In the first phase of the experiment, the effect of sympathetic tone change on T- and H-reflexes will be evaluated.
In the second phase of the experiment, 150 mg (single dose) of pregabalin will be given to these patients to reduce sympathetic activity and evaluate its effect on T- and H-reflexes.
干预措施: Pregabalin 150mg (Drug)
Healthy control group
The effect of sympathetic tone changes on T- and H-reflexes will be evaluated in healthy cases.
干预措施: sympathetic stimulation maneuver (mental arithmetic test, cold pressure test) (Diagnostic Test)
结局指标
主要结局
Change from baseline in H-reflex amplitude after intervention
时间窗: immediately after the intervention
The right tibial nerve will be stimulated with a monopolar technique from the popliteal region to elicit the soleus H-reflex response. The stimulation electrode (cathode) will be placed on the tibial nerve in the popliteal fossa and the anode will be placed on the prepatellar region. For stimulation, a 1ms monophasic square wave pulse current will be given. Mmax will be determined firstly.The current intensity providing a 10% Mmax response will be used to test the H-reflex response. H-reflex peak-to-peak amplitude will be measured in electromyographic recordings.
Change from baseline in T-reflex amplitude after intervention
时间窗: immediately after the intervention
In order to elicit the right soleus T-reflex, a constant-intensity strike will be made on the Achilles tendon with a reflex hammer at intervals of 10-15 seconds. An accelerometer will be placed over the Achilles tendon to measure T-reflex latency and confirm that strike intensities are constant. Recordings will be taken from the right soleus muscle. T-reflex peak-to-peak amplitudes will be measured in electromyographic recordings.
次要结局
- Heart rate variability(immediately after the intervention)
研究者
Tuğba Aydın
Principal Investigator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital