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, Richard L Kravitz

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Objectives: Opioids 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. Methods: We 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. Results: There 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 Registration: ClinicalTrials.gov Identifier: NCT02116621.

Original languageEnglish (US)
JournalJournal of general internal medicine
DOIs
StateAccepted/In press - Jan 1 2019

Fingerprint

Chronic Pain
Analgesics
Randomized Controlled Trials
Odds Ratio
Equipment and Supplies
Opioid Analgesics
Confidence Intervals
Morphine
Musculoskeletal Pain
Anti-Inflammatory Agents
Mobile Applications
Pharmaceutical Preparations
Telemedicine
Acetaminophen
Medical Records
Pain
Control Groups
Research

Keywords

  • analgesic
  • chronic pain
  • N-of-1 trials
  • non-steroidal anti-inflammatory agent
  • opioid

ASJC Scopus subject areas

  • Internal Medicine

Cite this

Effect of Mobile Device-Assisted N-of-1 Trial Participation on Analgesic Prescribing for Chronic Pain : Randomized Controlled Trial. / Odineal, David D.; Marois, Maria T.; Ward, Deborah; Schmid, Christopher H.; Cabrera, Rima; Sim, Ida; Wang, Youdan; Wilsey, Barth; Duan, Naihua; Henry, Stephen G; Kravitz, Richard L.

In: Journal of general internal medicine, 01.01.2019.

Research output: Contribution to journalArticle

Odineal, David D. ; Marois, Maria T. ; Ward, Deborah ; Schmid, Christopher H. ; Cabrera, Rima ; Sim, Ida ; Wang, Youdan ; Wilsey, Barth ; Duan, Naihua ; Henry, Stephen G ; Kravitz, Richard L. / Effect of Mobile Device-Assisted N-of-1 Trial Participation on Analgesic Prescribing for Chronic Pain : Randomized Controlled Trial. In: Journal of general internal medicine. 2019.
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abstract = "Objectives: Opioids 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. Methods: We 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. Results: There 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 Registration: ClinicalTrials.gov Identifier: NCT02116621.",
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AU - Schmid, Christopher H.

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N2 - Objectives: Opioids 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. Methods: We 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. Results: There 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 Registration: ClinicalTrials.gov Identifier: NCT02116621.

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