Evidence map›Paper›PMID 31463686›Full record

Trial reportJournal of general internal medicine2020

Effect of Mobile Device-Assisted N-of-1 Trial Participation on Analgesic Prescribing for Chronic Pain: Randomized Controlled Trial.

David D Odineal, Maria T Marois, Deborah Ward, Christopher H Schmid, Rima Cabrera, Ida Sim, Youdan Wang, Barth Wilsey, Naihua Duan, Stephen G Henry and 1 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of general internal medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02116621 (N-of-1 Trials Using mHealth in Chronic Pain Aka PREEMPT), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02116621 nacompletednot on this map

N-of-1 Trials Using mHealth in Chronic Pain Aka PREEMPT (Personalized Research for Monitoring Pain Treatment)

TypeinterventionalSponsorUniversity of California, DavisRan2014 to 2017Enrolled215ConditionsMusculoskeletal Pain, Chronic PainArmsTrialist Intervention, smartphone
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. The N-of-1 Trials and where to use them in Rheumatology.Mediterranean journal of rheumatology · 2025
    Review
  5. Review
  6. Article
  7. Article
  8. Review
  9. Article
  10. Review
  11. Article
  12. Article
  13. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 5 institutions in 1 country.

David D OdinealDepartment of Medicine, Madigan Army Medical Center, Joint Base Lewis McChord, Tacoma, WA, USA.
Maria T MaroisCenter for Health Care Policy and Research, University of California Davis, Sacramento, CA, USA.
Deborah WardBetty Irene Moore School of Nursing, University of California Davis, Sacramento, CA, USA.
Christopher H SchmidDepartment of Biostatistics, Brown University School of Public Health, Providence, RI, USA.
Rima CabreraCenter for Health Care Policy and Research, University of California Davis, Sacramento, CA, USA.
Ida SimDivision of General Internal Medicine, University of California San Francisco, San Francisco, CA, USA.
Youdan WangDepartment of Biostatistics, Brown University School of Public Health, Providence, RI, USA.
Barth WilseyVeterans Affairs Northern California Health Care System, Sacramento Medical Center, Mather, CA, USA.
Naihua DuanDepartment of Psychiatry, Columbia College of Physicians and Surgeons, New York, NY, USA.
Stephen G HenryDepartment of Internal Medicine, Division of General Medicine, University of California Davis, Sacramento, CA, USA.
Richard L KravitzDepartment of Internal Medicine, Division of General Medicine, University of California Davis, Sacramento, CA, USA. rlkravitz@ucdavis.edu.
University of California, Davis · USBrown University · USColumbia University · USOpen Society Foundations · USUniversity of California San Diego · US

Funding

UC Davis Clinical and Translational Science CenterUL1TR000002 · NCATS · UNIVERSITY OF CALIFORNIA AT DAVIS · PI BERGLUND, LARS F · 2012 to 2015
$12.2M
N-of-1 Trials Using mHealth in Chronic PainR01NR013938 · NINR · UNIVERSITY OF CALIFORNIA AT DAVIS · PI KRAVITZ, RICHARD L · 2012 to 2016
$2.9M
A clinician training intervention to improve pain-related communication, pain management and opioid prescribing in primary careK23DA043052 · NIDA · UNIVERSITY OF CALIFORNIA AT DAVIS · PI HENRY, STEPHEN G · 2017 to 2019
$591k
NCATS NIH HHS UL1 TR000002NIDA NIH HHS K23 DA043052NINR NIH HHS R01 NR013938
6 · The paper itself

Abstract

objectivesOpioids and non-steroidal anti-inflammatory drugs (NSAIDs) are frequently prescribed for chronic musculoskeletal pain, despite limited evidence of effectiveness and well-documented adverse effects. We assessed the effects of participating in a structured, personalized self-experiment ("N-of-1 trial") on analgesic prescribing in patients with chronic musculoskeletal pain.

methodsWe randomized 215 patients with chronic pain to participate in an N-of-1 trial facilitated by a mobile health app or to receive usual care. Medical records of participating patients were reviewed at enrollment and 6 months later to assess analgesic prescribing. We established thresholds of ≥ 50, ≥ 20, and > 0 morphine milligram equivalents (MMEs) per day to capture patients taking relatively high doses only, patients taking low-moderate as well as relatively high doses, and patients taking any dose of opioids, respectively.

resultsThere was no significant difference between the N-of-1 and control groups in the percentage of patients prescribed any opioids (relative odds ratio (ROR) = 1.05; 95% confidence interval [CI] = 0.61 to 1.80, p = 0.87). There was a clinically substantial but statistically not significant reduction of the percentage of patients receiving ≥ 20 MME (ROR = 0.58; 95% CI = 0.33 to 1.04, p = 0.07) and also in the percentage receiving ≥ 50 MME (ROR = 0.50; 95% CI = 0.19 to 1.34, p = 0.17). There was a significant reduction in the proportion of patients in the N-of-1 group prescribed NSAIDs compared with control (relative odds ratio = 0.53; 95% CI = 0.29 to 0.96, p = 0.04), with no concomitant increase in average pain intensity. There was no significant change in use of adjunctive medications (acetaminophen, gabapentenoids, or topicals). DISCUSSION: These exploratory results suggest that participation in N-of-1 trials may reduce long-term use of NSAIDs; there is also a weak signal for an effect on use of opioids. Additional research is needed to confirm these results and elucidate possible mechanisms.

trial registrationClinicalTrials.gov Identifier: NCT02116621.

Indexed as

Chronic PainAcetaminophenAnalgesicsAnalgesics, OpioidAnti-Inflammatory Agents, Non-SteroidalComputers, HandheldHumansAcetaminophenAnalgesicsAnalgesics, OpioidAnti-Inflammatory Agents, Non-Steroidalanalgesicchronic painN-of-1 trialsnon-steroidal anti-inflammatory agentopioid

Identifiers

PMID31463686
PMCPMC6957655
OpenAlexW2971060079

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.