Self-management of Chronic Pain Through the Use of the Digital Tool PainDrianer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Pain interference
研究概览
简要总结
The investigators aim to validate if a digital tool for increased self-management of chronic pain can improve the quality of life for patients with chronic pain. The validation is based on the change in pain interference (Quality of life), pain intensity, physical functioning, depression, and anxiety based on self-reported information from baseline to study end.
详细描述
Chronic pain is today an increasing health problem in both Europe and US, with an estimation of about 90 million people affected in Europe and 100 million people in US, or 20-30% of the adult population around the world. Chronic pain is defined as a condition that lasts for at least three to six months, after the normal healing period of an injury. Medical interventions offered in clinics around the globe are unfortunately not giving the results needed to give back the quality of life the patients had prior to the onset of the pain. The treatments offered today do sometimes reduce pain, but the effect is minor, and new treatment regimens are needed. Recent quality assurance registry measurements in Sweden has shown that patient taken part of multi modal treatment regimens, such as the acceptance and commitment therapy, (ACT) show that less then 40% of the patients have a decline in the pain level of 1 level on the VAS scale, 55% has no effect. The study objective is to evaluate how the use of a digital pain coach, based on artificial intelligence that improves the self-management of pain will decrease the pain interference and thereby increase QoL among chronic pain patients, as measured by PROMIS pain interference 6a. This study will compare the improvement of quality of life by a decrease in pain interference, measured by PROMIS, in patients who follow their traditional treatment plan provided by the Pain Clinic with the addition of using a web application for increased self management of pain. The theory behind the study and the development of the device is supported by previously known data, showing that self-management has an effect and is important to the treatment by helping patients to believe in their own capacity to control their pain.
The present investigation aims at exploring the effect of including digital tool as an add on to standard treatment and rehabilitation at the physiotherapy program at the clinic and will measure the effect it has on:
- Decreased pain interference
- Improved management of long-term pain and its consequences. Hence self management of pain
- Increased function in daily life with the best possible activity and participation level
- Improved experience of health-related quality of life
- Decreased pain experience
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
- Single (Care Provider)
盲法说明
Parallel study, single blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a pain condition that requires analysis and rehabilitation at a specialist clinic
- •>18 years of age
- •Be medically investigated, with adequate pharmacological treatment, and do not have any other medical examination or ongoing illness that hinders participation in the physiotherapy program at VO Neurosurgery and Pain rehabilitation, Skåne University Hospital, Lund
- •Meet the criteria for inclusion in the physiotherapy program: Have a chronic (> 3 months) state of pain with local, regional or spread location, where the pain is judged to be reduced by physiotherapeutic measures
- •Being included in the physiotherapy program, at VO Neurosurgery and Pain rehabilitation, Skåne University Hospital, Lund
- •Have the knowledge and proficiency to use a smart phone, tablet or computer
排除标准
- •Severe or acute psychiatric illness, severe anxiety or depression
结局指标
主要结局
Pain interference
时间窗: 6 and 12 weeks from baseline
Change from baseline in pain interference (QoL), measured by PROMIS Pain Interference 4a . Measure of the amount of interference pain causes in life; range 4-20; higher is worse
次要结局
- Pain severity(6 and 12 weeks from baseline)
- Physical function(6 and 12 weeks from baseline)
- Depression(6 and 12 weeks from baseline)
- Anxiety(6 and 12 weeks from baseline)
- Sleep disturbance(6 and 12 weeks from baseline)
- Fatigue(6 and 12 weeks from baseline)
- Ability to Participate in Social Roles and Activities(6 and 12 weeks from baseline)