N-of-1 Trials Using mHealth in Chronic Pain (PREEMPT)

University of California (UC) Davis

Status: Completed

Conditions: Musculoskeletal Pain; Chronic Pain

Treatments: Device: smartphone; Behavioral: Trialist Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02116621

496804

R01NR001938 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 215 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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215 participants in 2 patient groups

Trialist Intervention

Experimental group

Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Treatment:

Behavioral: Trialist Intervention

Device: smartphone

Control-Usual Care

No Intervention group

Description:

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app