Effect Of Neuromodulation on Pain and Quality of Life In Patient With Fibromyalgia Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Cortisol level
研究概览
简要总结
This study was designed to examine the efficacy of Neuromodulation therapy By using transcutanous electric nerve stimulation( TENS) in Patients With FMS and to provide preliminary evidence regarding its effects on pain ,anxiety and QOL by objectively measuring Cortisol level in FMS patients.
详细描述
Forty female patients with FM ( age : 20- 45 Years ) participated in the study after suing the consent form . Participants were randomly allocated assigned into 2 equal groups ( control group [ G1 ] and low TENS group [G2 ] ) . Group 1 received selected programs of Physiotherapy including Aerobic exercise and placebo low TENS. Group 2 received low frequency TENS (10 Hz).All participants were assessed for cortisol and pain level by using visual analogues scale Also participants were assessed for QOL by FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQR) . treatment was done 3 sessions per weeks for successive 6 weeks pre and post assessment for all valuable were Done.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women between 20-45 years old, (ii) diagnoses according to the 2016 American College of Rheumatology criteria for fibromyalgia [1]
- •Symptoms have been present at a similar level for at least three months (iii) Absence of other disorders that causes similar symptoms: systemic lupus erethromatosis (SLE), rheumatoid arthritis (RA) and Lyme disease based on laboratory investigations (erythrocyte sedimentation rate (ESR), Anti anti-cyclic citrullinated peptide (Anti CCP), antinuclear antibody (ANA) and Rheumatoid factor (RF)).
排除标准
- •any medical, neurological, or psychiatric illness, use of strong opioids or other painkillers except paracetamol and/or ibuprofen, benzodiazepine, illicit drug or alcohol use, recent use of cannabis, pregnancy, breast feeding, and the presence of pain syndromes other than FM.
- •Presence of other autoimmune disorders e.g.: rheumatoid arthritis and systemic lupus erethromatosus
研究组 & 干预措施
Control group
干预措施: Low frequency TENS (Device)
Low fequency TENS
干预措施: Low frequency TENS (Device)
结局指标
主要结局
Cortisol level
时间窗: Six weeks after begining of intervention
Changes in pain from baseline to six weeks after begining of intervention
次要结局
- Fibromyalgia impact questionaire(Six weeks after begining of intervention)
研究者
Rowida Abd Elgleel Sayed Abd Elgleel
Lecturer
Cairo University