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临床试验/NCT01893073
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

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2013年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
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

研究组 & 干预措施

Mindful walking

Active Comparator

A weekly 60 minutes walking group exercise program consisting of a combination of walking and mindfulness over 8 weeks.

干预措施: Mindful walking program (Behavioral)

Waiting group

No Intervention

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Benno Brinkhaus

Professor

Charite University, Berlin, Germany

研究点 (1)

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