NCT01893073已完成不适用
Effectiveness of a a Mindful Walking Program in Patients With Chronic Low Back Pain - a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Pain intensity on visual analogue scale
研究概览
简要总结
The purpose of this study is to determine whether a mindful walking program is effective in the treatment of patients with chronic low back pain.
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
- 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
- 否
入选标准
- •male and female, 18-65 years
- •chronic low back pain (disease duration > 3 months)
- •pain intensity on visual analogue scale at inclusion > 40 mm (0-100 mm scale)
- •only pharmacological treatment with NSAID or no treatment in the last 4 weeks
- •undersigned informed consent form
排除标准
- •active walking or jogging in the last 6 weeks (< 60 minutes/week)
- •regular meditation, relaxation exercise, mindfulness exercise in last 6 weeks (> 30 minutes per week)
- •use of complementary medicine therapies as acupuncture, homeopathy, herbal medicine in last 6 weeks or planned in the next 12 weeks
- •use of other nonpharmacological therapies as physical therapy, manual therapy or osteopathy in the last 4 weeks
- •participation in another trials within the last 3 months
- •pathological neurological symptoms such as muscular paralysis or paraesthesia due to spinal disc herniation or other causes
- •risk of falls and inability to walk
- •angina pectoris in the last 3 months
- •chronic respiratory disease with respiratory insufficiency
- •intake of central nervous system-acting analgesics in the last 6 weeks
- •Known renal and / or hepatic diseases
- •Severe organic, psychological or psychiatric disorders that are not permitting a study participation
- •applying for early retirement due to low back pain
- •no undersigned informed consent form
结局指标
主要结局
Pain intensity on visual analogue scale
时间窗: 8 weeks
次要结局
- Back function - FFbH-R-Questionnaire(8 weeks, 12 weeks)
- Pain intensity on visual analogue scale(12 weeks)
- Cohens perceived stress scale(8 weeks, 12 weeks)
- Quality of Life - SF 36(8 weeks, 12 weeks)
- Intake of paracetamol(8 weeks)
- Adverse events(8 weeks, 12 weeks)
研究者
Benno Brinkhaus
Professor
Charite University, Berlin, Germany
研究点 (2)
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