Effects of Osteopathic Manual Treatment on Interoception: 2- Armed RCT on cLBP Patients
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
- functional connectivity on right anterior insula cortex
研究概览
简要总结
Recent evidence suggested that the anterior insula cortex seems to be the main site of interoception. Several studies showed an association between change in insula function and interoception, bodily perception and consciousness in subjects with chronic pain. Although osteopathic research has been demonstrated to be effective in reducing pain, studies exploring the effect of osteopathy on interoception are lacking. Therefore, the aim of the present study is to explore the extent to which osteopathic treatment could modify interoception parameters both measuring brain functional connectivity and clinical questionnaires.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic low back pain
- •written informed consent signed
排除标准
- •congenital disease
- •acute pain
- •subject below 30 and above 50
- •co-morbidities associated with low back pain
- •surgical patients
- •cardio-vascular, respiratory, gastro-enteric disease
- •obese subjects
- •diabetics
- •dizziness
- •subjects into pharmacological prophylaxis
- •drug addicted subjects
- •subjects undergoing physiotherapy
- •subjects with experience in osteopathic treatment
研究组 & 干预措施
Sham
干预措施: sham osteopathic treatment (Other)
OMT
干预措施: osteopathic manipulative treatment (Other)
结局指标
主要结局
functional connectivity on right anterior insula cortex
时间窗: 4 weeks
before-after change in fMRI values
次要结局
- changes in GABA concentration(4 weeks)
- changes in depression symptoms(4 weeks)
- changes in anxiety symptoms(4 weeks)
- changes in perception of pain(4 weeks)
- changes in disability(4 weeks)
- acute changes on salience network(2 hours)
- differences on salience network activities(4 weeks)
- resting state network differences between groups(4 weeks)
- DTI changes between groups(4 weeks)
- changes in quality of life(4 weeks)
研究者
Francesco Cerritelli
DO, MS
Come Collaboration