N-of-1 Trials Using mHealth in Chronic Pain

Chronic musculoskeletal pain is an important problem, and treatments are often prescribed in
a "trial and error" fashion. Clinicians prescribe a treatment to a patient and then wait and
see if the treatment is successful. If the treatment is unsuccessful, they will try a
different treatment. The disadvantage to this method is that it may take a long time to find
a successful treatment.

The purpose of the PREEMPT Study is to test whether using a mobile phone application
("Trialist app") that allows patients and their health care providers to run personalized
experiments comparing two pain treatments is more effective than usual care. Patients
download the app, and working with their clinicians, set up a personalized trial that makes
sense for them. Every day they answer questions to track levels of pain and side effects of
treatment, such as fatigue and constipation. Once the personalized trial has ended, the
responses to these daily questions on each treatment will be compared. During a regular
clinic visit, the patient and the clinician will review visual displays of the results to
facilitate treatment decision-making. Approximately 250 patients will be enrolled in the
study. Half the patients will use the app and review results with the clinician, and half the
patients will continue with their regular care (i.e., will not use the app). The two groups
will be compared to see if using the app is successful in improving long term pain outcomes.
The goal of the intervention using the Trialist app is to help patients engage actively and
collaboratively with their clinicians and identify effective treatments more quickly.