N-of-1 Trials Using mHealth in Chronic Pain
CompletedNot applicableNCT02116621
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- N-of-1 Trials Using mHealth in Chronic Pain Aka PREEMPT (Personalized Research for Monitoring Pain Treatment)
- Conditions
- Interventions
- Behavioral: Trialist Intervention
- Device: smartphone
- Sponsor
- University of California, Davis
- Collaborators
- National Institute of Nursing Research (NINR)
- Start date
- 2014-07
- Primary completion
- 2017-02-01
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02116621