Molecular Response to Custom Manual Physiotherapy Treatment of Fibromyalgia & Chronic Fatigue Syndrome (CFS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Fatigue score
研究概览
简要总结
Fibromyalgia (FM)and Chronic Fatigue Syndrome (CFS) are complex diseases often presenting overlapping symptomatology. Manual therapy (MT) protocols report benefits for pain treatment of FM, but the underlying mechanisms for patient improvement remain unknown.
The main goal of this study is to assess the molecular changes associating to mechanical and additional MT triggers, possibly involved in patient symptom improvement.
详细描述
Patients with Fibromyalgia as primary diagnosis assessed by the 1990 & 2010 ACR (American College of Rheumatology) criteria, presenting or not comorbid CFS, according to the Canadian and International CFS criteria, age 40-75 and BMI<35 (N=40), will be subjected to physiotherapy treatment consisting on 8 sessions of manual therapy (twice weekly) of 25 minutes including pressure maneuvers of about 4,5 N by a single operator (Collegiate Physiotherapist). Blood samples (10-20mls/participant) will be obtained before and after first treatment, and after fourth and last treatment to determine molecular blood changes associated to the physiotherapy protocol applied. PBMC (Peripheral Blood Molecular Cells) transcriptome before and after treatments (RNAseq) will be studied towards identifying treatment-associated differential expression, mechanomiR profiles included. Patient health status with treatment will be monitored by FIQ, MFI and SF-36 questionnaires, in addition to an anonymized satisfaction questionnaire to register potential undesired secondary effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Outcome measures will be randomized and anonymized
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of FM with or without comorbid CFS
- •Not receiving hormone therapy
- •Not suffering from other diseases
- •Without previous history of cancer
- •Not actively participating in any pharmacological trial
- •Not taking medication for at least 12 hours before blood draw
- •Having signed informed consent
排除标准
- •Any uncompliance with what is described as inclusion criteria
结局指标
主要结局
Fatigue score
时间窗: 8 weeks
MFI, 1-5 scale (20 items), higher scores indicate higher degree of fatigue
Differential gene expression
时间窗: 8 weeks
RNAseq
Pain index
时间窗: 8 weeks
FIQ and Visual analogue scale (VAS) of pain, Scale 0-100, \<39 mild, 39-58 moderate, ≥59 severe
次要结局
- Quality of life score(8 weeks)
- ANS (autonomic nervous system) dysfunction(8 weeks)
研究者
María García Escudero
Professor
Fundación Universidad Católica de Valencia San Vicente Mártir