Genetic Characteristics and Determinants of Central Sensitization of Nociception in Fibromylagic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Evaluation of nociception flexion reflex (RIII) threshold by electromyography
研究概览
简要总结
Fibromyalgia syndrome (FS) is characterized by widespread pain and affect 0.5 to 5 % of the general population, with a higher prevalence in women. Recognized as disease by World Health Organization since 1992, FS concern 1.2 to 2 million of French people and his etiology need to be clarified. This affection is characterized by a higher sensitivity to nociceptive stimulus, articular and muscular pain and associated to: fatigue, headache, sleep disorders, depression and irritated bowel syndrome. The presentation of this symptoms varied according to the patient with a heterogeneity of the clinical, physical, social and psychologic conditions and of the therapeutic responses.
Faced to the heterogeneity of FS, various hypotheses about the development mechanisms exist. Central sensitization could be one of the key mechanisms of FS, it is described as a loss of the natural balance between the transmission of a painful stimulus to the central nervous system and pain-inhibiting mechanisms, which results in permanent or chronic pain.
Moreover, work on the familial character of FS suggests that a genetic component may be involved in its development, but the identification of a genetic determinant is difficult given the multifactorial nature and complexity of FS.
The objective of this study is to characterize the predispositions of central sensitization and genetics in patients with FS compared to a control group, matched in age, sex and menopausal status.
详细描述
This is an exploratory case control pathophysiology study of psychophysical (central sensitization assessment) and genetic (candidate gene panel) characteristics.
The main objectives of this study are :
Primary: Evaluate the central nociception sensitization characteristics and genetic determinants in fibromyalgic syndrome, comparing a group of patients to matched healthy controls.
Secondary :
- 1) Characterize genetic predispositions of central sensitization in patients with FS compared to matched healthy controls, including confirmation of known genetic markers and potential identification of new genetic variants involved,
- 2) Compare in the area of central sensitization the population of patients with FS and matched healthy controls,
- 3) Compare in the domain of temporal summation the population of patients with FS and matched healthy controls,
- 4) Describe in the clinical field the characteristics of the FS patient population,
- 5) Compare in the areas of quality of life, anxiety/depression and comorbidities, characteristics of the FS patient population and matched healthy controls,
- 6) Compare epigenetic biomarkers of the FS patient population with healthy matched controls,
- 7) Study of the role of the gut microbiota in patients with FS (bio banking)
- 8) Compare in the areas of pain, sound and light sensitivity the population of patients with FS and matched healthy controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Patient Inclusion criteria :
- •Patient between 18 and 65 years old (included),
- •Patient with fibromyalgia according to the criteria of the 2016 ACR,
- •Patient weighing more than 45kg
- •Cooperation and understanding sufficient to comply with the requirements of the study,
- •Acceptance to give written consent,
- •Affiliation to the French Social Security system,
排除标准
- •treated with antibiotics in the three months prior to inclusion,
- •who has reported gastroenteritis in the two months prior to inclusion,
- •having a medical and / or surgical history judged by the investigator or his representative to be incompatible with the test
- •of childbearing age not using an effective contraceptive method, pregnant or breastfeeding woman.
- •participating in another clinical trial, or being in the exclusion period, or having received a total amount of benefits exceeding EUR 4500 over the 12 months preceding the start of the trial,
- •benefiting from a measure of legal protection (guardianship, guardianship, deprivation of liberty, safeguard of justice),
- •Subject inclusion criteria:
- •Aged of more than 18 years,
- •weighing more than 45kg
- •non-painful subjects matched by age (+/- 5 years), by sex, and by menopausal status for women,
- •Cooperation and understanding sufficient to comply with the requirements of the study,
- •Acceptance of written consent,
- •Affiliation to the French Social Security system,
- •Registration or acceptance of registration in the National Register of Volunteers participating in research.
- •Subject exclusion criteria :
- •treated with antibiotics in the three months prior to inclusion,
- •who has reported gastroenteritis in the two months prior to inclusion,
- •Medical and / or surgical history judged by the investigator or his representative to be incompatible with the test,
- •Intake of any drugs in the 7 days before inclusion,
- •Pregnant or nursing woman
- •Participating in another clinical trial, or within the exclusion period, or having received a total amount of compensation in excess of EUR 4500 over the 12 months preceding the start of the trial,
- •Benefiting from a measure of legal protection (curatorship, guardianship, safeguard of justice ...)
研究组 & 干预措施
Patient with fibromyalgia syndrome
250 patients with fibromyalgia syndrome (according to American College of Rheumatology 2016) will realize explorations to characterize central sensitization: reflex nociceptive flexion threshold by electrophysiological measure and blood sampling for evaluate the distribution of gene polymorphism.
干预措施: Electrophysiological measurement of reflex nociceptive flexion threshold (RIII reflex) using Nicolet Vicking device (Device)
Healthy subjects
50 healthy matched volunteers (age, sex and menopausal status for women) will realize explorations to characterize central sensitization: reflex nociceptive flexion threshold by electrophysiological measure and blood sampling for evaluate distribution of gene polymorphism
干预措施: Electrophysiological measurement of reflex nociceptive flexion threshold (RIII reflex) using Nicolet Vicking device (Device)
结局指标
主要结局
Evaluation of nociception flexion reflex (RIII) threshold by electromyography
时间窗: Day 1
Patient rested comfortably in a supine position in order to obtain muscular relaxation. Cutaneous electrodes will be applied, and the sural nerve will be stimulated in its retromaleolar track. Electromyographic responses will recorded using the Nicolet Vicking device with a pair of surface electrodes placed over the tendon of the ipsilateral biceps femoris. The R-III reflex (objective threshold) will be identified as a multiphasic signal appearing at least 90 ms but less than 250 ms after each stimulation and will be considered to be present when the corrected computed surface was \>0.5 mV/ms (positive response).
次要结局
- Mechanical temporal summation by numerical scale (0 to 10)(Day 1)
- Concise Pain Questionnaire (QCD)(Day 1)
- Detection of fibromyalgia using the FIRST questionnaire(Day 1)
- Analysis of the microbiota (stool samples),(Day 1)
- Evaluation of sensitivity to pain by PSQ questionnaire(Day 1)
- Evaluation of central sensitization(Day 1)
- Emotional status by Hospital Anxiety and Depression scale (HAD)(Day 1)
- Evaluation of micro ARN using OpenArray technology(Day 1)
- Evaluation of sensitivity to light by led panel(Day 1)
- Evaluation of genetic polymorphism using OpenArray technology(day 1)
- Evaluation of the impact of fibromyalgia using the FIQ questionnaire(Day 1)
- Evaluation of the Suspended Symmetrical Dorsal Cellulalgia(Day 1)
- Quality of life by SF-36 quality of life questionnaire(Day 1)
- Evaluation of sensitivity to sound by audiometer(Day 1)