A Randomized Pragmatic Trial About the Effectiveness of an App Based Relaxation Technique for Patients With Chronic Neck Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 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 neck 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 neck 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) neck 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
- 主要目的
- Other
- 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 neck pain for at least 12 weeks
- •if additional back pain is reported, neck pain has to be predominant
- •intensity of the average neck 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)
- •physical and mental ability to participate in the study
- •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 a smart phone application
- •written and oral informed consent
排除标准
- •neck 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 neck 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
研究组 & 干预措施
relaxation exercise
Participants allocated to the relaxation group will apply daily but at least five days a week a 15-minutes relaxation exercise, guided by a smartphone application (App). On a daily basis, participants can select one out of the three exercises (guided imagery, mindfulness based training, autogenic training) which they want to apply
干预措施: relaxation exercise (Behavioral)
usual care waiting list
Patients allocated to the usual care waiting list group will continue with their usual care without receiving any additional therapy
干预措施: ususal care (Other)
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
- 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 month)
- medication intake(3 and 6 months)
- Number of sick leave days(3 and 6 months)
- Stress(3 and 6 months)
- Suspected adverse reaction(3 and 6 month)
- Pain acceptance(3 and 6 months)
研究者
Claudia M. Witt
Prof Dr. Claudia M. Witt
Charite University, Berlin, Germany