A Randomized Pragmatic Trial About the Effectiveness of an App Based Relaxation Technique for Patients With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Primary outcome is the mean pain intensity over 3 months measured by the daily pain intensity on the Numeric rating scale (NRS)
研究概览
简要总结
The aim of the pragmatic randomized study is to evaluate whether additional relaxation technique is more effective in the reduction of chronic low back pain compared to usual care alone.
详细描述
Objective
To evaluate whether additional relaxation technique is more effective in the reduction of chronic low back pain compared to usual care alone.
Study design: Open single-centered randomized two-armed pragmatic trial.
Participants: 220 patients aged 18-65 years with chronic (>12 weeks) low back pain and a mean pain score ≥ 4 on a Numeric Rating scale (NRS) in the last week before randomization who will be randomly allocated to two groups (relaxation, usual care alone as waiting list)
Intervention: Participants apply either a daily 15-minute relaxation exercise guided by a smartphone application ("app"). or apply no additional intervention. The exercise should be applied daily, (minimally five days per week) for 6 months. The app contains audios to guide autogenic training, muscle relaxation training and guided imagery. On a daily basis, participants can select one of the three exercises which they want to apply.
Main outcome measure: The primary outcome is the mean pain intensity after 3 months measured by the daily pain intensity on the NRS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •female or male
- •18-65 years of age
- •chronic low back pain for at least 12 weeks
- •if additional back pain is reported, low back pain has to be predominant
- •intensity of the average low back pain ≥ 4 on the numeric rating scale (NRS) in the last week
- •presence of a smartphone (iphone, Android phone) and willingness to do data entry through a smart phone application (App)
- •willingness to be randomized, to apply study intervention according to the protocol, to complete the baseline questionnaire in paper form and electronic questionnaires and diaries provided by an App physical and mental ability to participate in the study
- •written and oral informed consent
排除标准
- •low back pain caused by a known malignant disease
- •neck pain caused by trauma
- •known rheumatic disorder
- •history or planned surgery of the spinal column of the low back in the next 6 months
- •known neurological symptoms e.g radicular symptoms because of prolapsed vertebral disc
- •regular intake of analgesics (>1x per week) because of additional diseases
- •intake of centrally acting analgesics
- •known severe acute or chronic disorder, that do not allow participation in the therapy
- •other known diseases, that do not allow participation in the therapy
- •known alcohol or substance abuse
- •no sufficient German language skills
- •current application for a benefit
- •participation in another clinical trial during six months before the study and parallel to the study
- •conducting regular relaxation techniques, mindfulness training or meditation six weeks before the study or planned in the next 6 months
结局指标
主要结局
Primary outcome is the mean pain intensity over 3 months measured by the daily pain intensity on the Numeric rating scale (NRS)
时间窗: 3 months
次要结局
- Pain acceptance(3 and 6 months)
- Stress(3 and 6 months)
- Suspected adverse reaction(3 and 6 months)
- medication intake(3 and 6 months)
- Mean pain intensity measured by the daily pain intensity on the NRS(6 months)
- Mean pain intensity measured weekly as the average pain intensity of the last seven days on a NRS(3 and 6 months)
- Number of Serious adverse event(3 and 6 months)
- Number of sick leave days(3 and 6 months)
研究者
Claudia M. Witt
Prof. Dr. med.
Charite University, Berlin, Germany