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

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 shouldbe improved if the impact of medical interventions is to be improved. Ecologicalmomentary assessment usingsmartphones is now considered the gold standard in monitoring in health settings, including chronic pain. However, tothe best of our knowledge, there is no randomized controlledtrial to show that telemonitoring using a smartphone appcan indeed improve the effectiveness of medical treatmentsin adults with chronic pain. The goal of this study will be toexplore 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 adequatetreatment for their pain, which will be prescribed thefirst day of study according to clinical guidelines. Assessment in the TAU group will be the usual at the Pain Clinic, thatis, a paper-and-pencil evaluation at the onset of treatment (beginning of study) and at follow up (end of study, 30 dayslater). The other two groups (TAU+app and TAU+app+alarms) will be assessed daily using Pain Monitor, a smartphoneapp 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 isnot the usual practice at the Pain Clinic and will not occur in the other two groups (TAU and TAU+app), so no changesin treatment are expected in these groups after the first appointment. The total sample size will be 150, with 50 patientsin each group. The assessment protocol will be the same in all groups and will include pain intensity and side effects ofthe medication (primary outcomes), together with several pain-related variables like pain interference, activity level, useof rescue medication, pain catastrophizing, and pain acceptance, among others. Discussion: We believe that the present trial has important clinical implications. We think that telemonitoringusing ecological momentary assessment is crucial to improve current interventions for pain. The armamentarium ofavailable treatments for pain is large, so physicians can turn to different treatments or dosages in the presence of anundesired 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 shouldtake advantage of them in the promotion of health care