Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03678155 |
| Other study ID # |
UJI_PainMonitor_Multicenter |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 15, 2018 |
| Est. completion date |
December 15, 2020 |
Study information
| Verified date |
April 2021 |
| Source |
Universitat Jaume I |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The present investigation aims at exploring the effect of including a pain app called Pain
Monitor for chronic pain patients' daily monitoring. Two conditions will be set:
1. usual treatment + app (without alarms)
2. usual treatment + app (with alarms)
Description:
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. Rosser and Eccleston
conducted a comprehensive review of existing apps for pain and the conclusion was that there
was little evidence to support the use of current apps. Specifically, these authors showed
that most apps did not specify whether their content was validated, did not include
psychological components and none had been applied in a clinical study. In light of these
results, Dr. Carlos Suso Ribera and Dr. Ribera Canudas contacted the research team Labpsitec
of Jaume I University, who were developing an application for pain called "Pain Monitor". Dr.
Carlos Suso Ribera and Dr. Ribera Canudas of the Pain Unit collaborated with Dr. Azucena
García Palacios and Dr. Diana Castilla López of the Universitat Jaume I in the final
development of the application of pain, Following the guidelines of Rosser and Eccleston. App
content validity and usability was tested in a previous study at the pain unit of the Vall
d'Hebron Hospital. Thus, the study objective is to test if the introduction of this tool in
the day-to-day work of the pain unit improves pain management of chronic pain patients. To do
this, it is necessary to compare the evolution of patients who follow the usual treatment at
the pain unit (without app) with a group of patients who do use the Pain Monitor app. In
addition, the present study investigators have created a new utility that allows alarms to be
generated by healthcare professionals in the presence of an undesired event, such as an
adverse effect of the medication or a lack of response to medical treatment. Before
determining that both the use of the app and this new utility (alarms) are beneficial for
patient care, it is necessary to perform a clinical trial comparing the 3 conditions
mentioned above:
1. usual treatment + app (without alarms)
2. usual treatment + app (with alarms) Therefore, this is a clinical trial without drugs.
This is not an observational study since the physicians of patients in the app + alarms
condition will be asked to react to an alarm (i.e., if the patient has nausea for 3
consecutive days) by calling the patient and changing the treatment telematically, if
necessary, so that the patient can collect the prescription at his primary care center.
If the condition app with alarms results in a better treatment of chronic pain patients,
participants of the other two conditions will be offered the possibility to use the app
with alarms at the end of the study. The study will be conducted at the Pain Unit of the
Vall d'Hebron Hospital. All study procedures have been approved by the ethical committee
of the Vall d'Hebron Hospital.
