NCT01293019已完成3 期
Impact of an Osteopathic Manipulative Treatment on Pain of Adult Patients With Cystic Fibrosis - a Pilot Study
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Pain score
研究概览
简要总结
To study the contribution of osteopathy on the reduction of pain in adult patients with cystic fibrosis
详细描述
To compare the impact of osteopathic treatment to a placebo of osteopathic treatment and to usual care on pain at 6 months in adult patient with cystic fibrosis localized to chest, cervical, dorsal neck or back.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cystic fibrosis ( positive sweat test and / or presence of 2 disease causing mutations in the CFTR gene
- •Age > 18 years
- •Patient with chronic chest , neck or back pain
- •Written Informed Consent
- •with health insurance
排除标准
- •regular follow-up by an osteopathic physician in the previous 3 months
- •patients awaiting lung transplantation
- •history of lung transplantation
- •pregnancy
- •understanding disorders preventing the patient to apply the study
- •participation in another clinical interventional study protocol
研究组 & 干预措施
Experimental
Experimental
Osteopathic treatment
干预措施: Osteopathic treatment (Procedure)
Placebo
Placebo Comparator
Sham osteopathic treatment
干预措施: Sham Placebo (Procedure)
Usual care
Active Comparator
Classic treatment of cystic fibrosis patients
干预措施: Usual care (Procedure)
结局指标
主要结局
Pain score
时间窗: at 6 months
次要结局
- quality of life scores(at 6 months)
- Co-interventions(at 6 months)
研究者
研究点 (2)
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