Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03606265 |
| Other study ID # |
GeneralAPP |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 15, 2018 |
| Est. completion date |
March 29, 2021 |
Study information
| Verified date |
July 2021 |
| Source |
Universitat Jaume I |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study will compare the effectiveness of a web-based app compared to the treatment as
usual without an app for the telemonitoring of patients with chronic pain. Two conditions
will be set:
1. usual treatment (waiting list)
2. usual treatment + app
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
Hospital General de Castellón 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 (Suso-Ribera et al., in preparation). 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.
