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临床试验/NCT03247725
NCT03247725已完成不适用

Pain Monitor: a Randomized Controlled Trial to Test the Efficacy of a Pain App in the Treatment of Chronic Pain

Universitat Jaume I2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年9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
发起方
入组人数
150
试验地点
2
主要终点
Change in pain intensity

研究概览

简要总结

The present investigation aims at exploring the effect of including a pain app called Pain Monitor for chronic pain patients' daily monitoring. Three conditions will be set:

  1. usual treatment (waiting list)
  2. usual treatment + app (without alarms)
  3. usual treatment + app (with alarms)

详细描述

Chronic pain is defined as one that lasts for at least three to six months, provided that this time is greater than the normal healing period of an injury. This pathology has become an important public health problem due to its high prevalence. In particular, it is estimated that it affects 20-30% of the adult population around the world. Medical interventions are the first-line treatment in recent clinical practice guidelines. Unfortunately, the effectiveness of medical interventions is only modest. Treatments significantly reduce pain on average, but the effect tends to be small . In addition, the drugs are not effective for a large percentage of patients.

What these and other research suggest is that focusing only on large sample studies and the use of average change scores calls into question the usefulness of current patient-centered treatments. As noted by Dr. Turk, when data are averaged, various pain syndromes, drugs, surgical procedures, and studies in different countries are often included, which may mask the efficacy results of different treatments with Different samples. Single case methodology could be one of the ways to overcome these limitations. The single case investigation is a type of experimental study that offers experimental control within a single case.

Some studies have already demonstrated the usefulness of these designs in chronic pain. In fact, the benefits of using this methodology as opposed to large sample studies were discussed recently during the 10th Congress of the European Pain Federation. These benefits include the need for a reduced number of participants, the ability to follow clinical evolution in real time and continuously, the amount of data provided, and applicability when using a control group is impractical or unethical.

The investigators conducting the present investigation recently conducted a study at the Pain Unit of the Vall d'Hebron Hospital to explore the effectiveness of current medical treatments. According to previous investigations, the treatment effect was only small (d = 0.32) and only a percentage of the patients (18.1%) had a clinically significant reduction of pain (ie a reduction greater than 30% ).

From these results and the literature reviewed, a single case design could be an alternative method for research in the Pain Unit. However, the implementation of this type of methodology can be very costly due to the continuous evaluation of the evolution of the patient. In this sense, several studies have already shown that mobile applications (app) can effectively control the evolution of a wide range of pathologies in health settings . In fact, a recent controlled clinical study found that ecological records performed with mobile app had greater reliability than paper-and-pencil records.

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

盲法说明

Patients will be informed of the condition they have been assigned to.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patient is over 18 years of age
  • The patient has a mobile phone with Android operating system
  • The patient has the physical ability to use the application
  • The patient does not present psychological and / or cognitive alterations or problems with language that make their participation difficult
  • The patient voluntarily wants to participate and signs the informed consent

排除标准

  • The patient is under 18 years
  • The patient does not have a mobile phone or has a mobile phone in which Android is not the operating system (the app is currently only available for Android for economic reasons)
  • The patient does not have the physical capacity to use the application
  • The patient does not have the capacity to participate due to psychological and / or cognitive alterations or problems with language
  • The patient does not want to participate

研究组 & 干预措施

Treatment as usual (waiting list)

Active Comparator

Patients at this condition will receive the usual medical treatment at the pain unit, but they will not be monitored daily using the app.

干预措施: Treatment as usual (medical) (Other)

Treatment as usual + app (without alarm)

Experimental

Participants at this condition will receive the usual medical treatment for their pain but also they will be monitored daily using the Pain Monitor app. Because alarms will not be generated, physicians will not know if an undesired event is occuring despite the app is actually collecting data.

干预措施: pain app (Other)

Treatment as usual + app (without alarm)

Experimental

Participants at this condition will receive the usual medical treatment for their pain but also they will be monitored daily using the Pain Monitor app. Because alarms will not be generated, physicians will not know if an undesired event is occuring despite the app is actually collecting data.

干预措施: Treatment as usual (medical) (Other)

Treatment as usual + app (with alarm)

Experimental

Participants at this condition will receive the usual medical treatment for their pain but also they will be monitored daily using the Pain Monitor app. Alarms will be generated in the face of certain preestablished events. Physicians will be asked to call patients and change/stop treatment if an alarm is received.

干预措施: pain app (Other)

Treatment as usual + app (with alarm)

Experimental

Participants at this condition will receive the usual medical treatment for their pain but also they will be monitored daily using the Pain Monitor app. Alarms will be generated in the face of certain preestablished events. Physicians will be asked to call patients and change/stop treatment if an alarm is received.

干预措施: Treatment as usual (medical) (Other)

结局指标

主要结局

Change in pain intensity

时间窗: Twice (first day of study and 30 days after, at the end of study) in the TAU condition

A numerical rating scale (0-10 range) will be used.

Change in side effects

时间窗: Twice (first day of study and 30 days after, at the end of study) in the TAU condition

A list of the most frequent side effects of pain medication was created

次要结局

  • Change in general health(Twice (first day of study and 30 days after, at the end of study) in the TAU condition)
  • Change in pain acceptance(Twice (first day of study and 30 days after, at the end of study) in the TAU condition)
  • Change in pain catastrophizing(Twice (first day of study and 30 days after, at the end of study) in the TAU condition)
  • Change in rescue medication use(Twice (first day of study and 30 days after, at the end of study) in the TAU condition)
  • Change in mood(Twice (first day of study and 30 days after, at the end of study) in the TAU condition)
  • Change in fear of pain(Twice (first day of study and 30 days after, at the end of study) in the TAU condition)
  • Change in pain interference(Twice (first day of study and 30 days after, at the end of study) in the TAU condition)

研究者

发起方
Universitat Jaume I
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlos Suso Ribera

Principal Investigator

Universitat Jaume I

研究点 (2)

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