Improving pain treatment with a smartphone app: study protocol for a randomized controlled trial

Carlos Suso-Ribera, Ángela Mesas, Javier Medel, Anna Server, Esther Márquez, Diana Castilla, Irene Zaragozá, Azucena García-Palacios, Carlos Suso-Ribera, Ángela Mesas, Javier Medel, Anna Server, Esther Márquez, Diana Castilla, Irene Zaragozá, Azucena García-Palacios

Abstract

Background: Chronic pain has become a major health problem across the world, especially in older adults. Unfortunately, the effectiveness of medical interventions is modest. Some have argued that assessment strategies should be improved if the impact of medical interventions is to be improved. Ecological momentary assessment using smartphones is now considered the gold standard in monitoring in health settings, including chronic pain. However, to the best of our knowledge, there is no randomized controlled trial to show that telemonitoring using a smartphone app can indeed improve the effectiveness of medical treatments in adults with chronic pain. The goal of this study will be to explore the effects of using a smartphone app for telemonitoring adults with chronic pain.

Methods: The study will be a randomized controlled trial with three groups: treatment as usual (TAU), TAU+app, and TAU+app+alarms. All groups will receive the adequate treatment for their pain, which will be prescribed the first day of study according to clinical guidelines. Assessment in the TAU group will be the usual at the Pain Clinic, that is, a paper-and-pencil evaluation at the onset of treatment (beginning of study) and at follow up (end of study, 30 days later). The other two groups (TAU+app and TAU+app+alarms) will be assessed daily using Pain Monitor, a smartphone app developed by our multidisciplinary team. Telemonitoring will only be made in the TAU+app+alarms group. For this group, physicians at the Pain Clinic may decide to adjust pain treatment in response to alarms. Telemonitoring is not the usual practice at the Pain Clinic and will not occur in the other two groups (TAU and TAU+app), so no changes in treatment are expected in these groups after the first appointment. The total sample size will be 150, with 50 patients in each group. The assessment protocol will be the same in all groups and will include pain intensity and side effects of the medication (primary outcomes), together with several pain-related variables like pain interference, activity level, use of rescue medication, pain catastrophizing, and pain acceptance, among others.

Discussion: We believe that the present trial has important clinical implications. We think that telemonitoring using ecological momentary assessment is crucial to improve current interventions for pain. The armamentarium of available treatments for pain is large, so physicians can turn to different treatments or dosages in the presence of an undesired event. The use of the app for telemonitoring can allow for this rapid detection of unwanted events, thus improving patient safety (i.e., withdrawal of treatment causing side effects) and augmenting treatment effectiveness (i.e., changing an ineffective treatment or dosage). In a time when smartphones are a mainstream technology, we should take advantage of them in the promotion of health care.

Trial registration: ClinicalTrials.gov, NCT03247725 . Registered on 25 July 2017.

Keywords: Chronic pain; Ecological momentary assessment; Randomized controlled trial; Smartphone app; Telemonitoring.

Conflict of interest statement

Authors’ information

Not applicable.

Ethics approval and consent to participate

This study was approved by the Ethical Review Board at the Vall d’Hebron Hospital in Barcelona (June 25, 2017). All participants gave their written consent to participate.

Consent for publication

Not applicable (the study does not contain individual data).

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Schedule of enrolment, interventions, and assessments. All patients received the usual treatment for their pain irrespective of their group allocation
Fig. 2
Fig. 2
Example of two app items

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