N-of-1 Trials Using mHealth in Chronic Pain

Completed · Not applicable

Conditions studied: Musculoskeletal Pain, Chronic Pain

In brief

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.

Key facts

Study ID: NCT02116621
Run by: University of California, Davis
People needed: 215
Starts: 2014-07-01
Expected to finish: 2017-05-01
Last updated by the study team: 2018-05-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Chronic musculoskeletal pain (e.g., neck, back, extremities) operationalized as pain present for 6 weeks or more and a pain score of 4 or higher (on a 0-to-10 scale) on at least one of three items from the PEG pain scale
Age 18-75 years
Own web-enabled Android or iOS phone with data plan
In judgment of treating clinician, pain potentially amenable to treatment with acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), low-dose opioids, a complementary/alternative treatment such as massage or meditation, or a simple combination of these treatments
Ability to speak and read English

You may not qualify if…

Treated with surgery, radiation or chemotherapy for cancer in past 5 years
Other medical conditions that in clinician's judgment would limit life expectancy to less than 2 years or imperil patient safety
Pregnant or breastfeeding
Dementia, bipolar disorder, schizophrenia, active suicidality
Current alcohol or prescription drug abuse; history of disruptive behavior
Failed 5 or more analgesic medications because of lack of effectiveness or poor tolerability

Where it is running

Veteran's Administration-Northern California Health Care System — Mather, California, United States
University of California, Davis Medical Center — Sacramento, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.