NCT07528833招募中不适用
Health Effects of Mindfulness Based Stress Reduction Course Versus Usual Care in Treatment of Back Pain: a Randomized Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Numeric pain rating scale
研究概览
简要总结
- Health effects of mindfulness based stress reduction course versus usual care in treatment of back pain: a randomized clinical trial
- Mindfulness based stress reduction (MBSR) course intervention for half of the research patients
- MBSR course lasts for 8 weeks.
- follow-up time 2 years.
- research data is collected by Recdap
- Working-age (18-64 years) patients with back pain in thoracal or lumbar area (NRS at least 4) with or without radiculation over 12 weeks will be recruited.
- The primary outcome measure is Numeric pain rating scale (NRS, 0-10).
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Working-age (18-64 years) patients
- •Back pain in thoracal or lumbar area
- •NRS at least 4
- •With or without radiculative symptoms
- •Pain duration over 12 weeks
- •Pain can be localized or widespread
- •Also patients with multiple pain are eligible
- •X-ray or MRI scan is not needed
- •Patients can be both gender
- •Finnish language skills and adequate competence are needed for filling the survey forms and participation in interventions
排除标准
- •Pregnancy
- •Recent delivery (<12 months)
- •Mental health problems with psychotic symptoms
- •Acute severe psychological trauma (3 months)
- •Sings of back infection
- •Acute severe trauma in the back (fracture)
- •surgery (< 6 months)
- •planned surgery in the future
- •tumor in the back
研究组 & 干预措施
MBSR intervention
Experimental
干预措施: Mindfulness based stress reduction (MBSR) course (Behavioral)
Control group with usual care for back pain
No Intervention
结局指标
主要结局
Numeric pain rating scale
时间窗: 2 years
0 (no pain), 10 (worst imaginable pain)
次要结局
- Consumption of antidepressants(2 years)
- ODI(2 years)
- Total patient-experienced pain interference(2 years)
- Claudication distance(2 years)
- Radiculative symptoms(2 years)
- Multiple pain in other areas(2 years)
- Amount of physiotherapy contacts(2 years)
- Amount of mental health contacts(2 years)
- Amount of sick leave(2 years)
- Burnout assessement tool (BAT-12)(2 years)
- GAD-7(2 years)
- BDI-2(2 years)
- EQ-5D-5L(2 years)
- Consumption of alcohol(2 years)
- Sleeping problems(2 years)
- Consumption of cigarettes(2 years)
- Body weight(2 years)
- Physical acitivity(2 years)
- Consumption of painkillers(2 years)
- Consumption of benzodiazepines(2 years)
- Consumption of muscle relaxants(2 years)
- Experienced benefit from the MBSR- course(2 years)
- Complications of the intervention(2 years)
- Experienced total work ability now(2 years)
- Experienced mental work ability now(2 years)
- Experienced physical work ability now(2 years)
- Experienced total work ability after 2 years(2 years)
- Experienced mental work ability after 2 years(2 years)
- Experienced physical work ability after 2 years(2 years)
- Previous psychological diagnoses(2 years)
- Rate of participation in MBSR course meetings(2 years)
- Amount of daily mindfulness practice(2 years)
- Other received rehabilitation(2 years)
- Amount of contacts to the doctor for back pain(2 years)
- Experienced calmness during the last week(2 years)
- Experienced happiness during the last week(2 years)
- Experienced state of feeling energetic during the last week(2 years)
- Experienced contentment during the last week(2 years)
研究者
研究点 (4)
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