Dataset Information

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

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.

SUBMITTER: Odineal DD

PROVIDER: S-EPMC6957655 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Odineal David D DD Marois Maria T MT Ward Deborah D Schmid Christopher H CH Cabrera Rima R Sim Ida I Wang Youdan Y Wilsey Barth B Duan Naihua N Henry Stephen G SG Kravitz Richard L RL

Journal of general internal medicine 20190828 1

<h4>Objectives</h4>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.<h4>Methods</h4>We randomized 215 patients with chronic pain to participate in an N-of-1 trial facilitated b ...[more]

PMID: 31463686

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Project description:ObjectivesTo determine if a topically applied non-steroidal anti-inflammatory drug (diclofenac) can provide short-term pain relief for chronic Achilles tendinopathy (CAT), in order to inform the development of a new rehabilitation protocol.Design and settingPilot double-blind, cross-over randomised controlled trial providing participants with tertiary care. The study was conducted at a single research centre in Vancouver, BC.ParticipantsSixteen adults with unilateral CAT and three adults with bilateral CAT participated.InterventionsParticipants received two successive treatments (10% diclofenac gel or placebo gel) in random order over a 3-day period. There was a 1-week washout period between the treatments. Allocation was by simple randomisation, and the participants as well as the assessing/treating researcher were blinded to treatment allocation.Outcome measuresThe primary outcome measure was pain level (0-10) during tendon loading (hopping). Secondary outcome measures included pain at rest, pressure pain threshold of the Achilles tendon and symptom improvement.ResultsNineteen adults participated in the study, and all were included in the analysis. Diclofenac gel significantly reduced the average pain during tendon loading (p<0.001) and at rest (p=0.031). The average baseline hopping pain was 4.8/10 (95% CI 3.92?to 5.68) and was reduced to 3.1/10 (2.35-3.85) by diclofenac. Pain at rest was decreased and pressure pain threshold increased with diclofenac treatment, but not with placebo gel. There were no observed or reported side effects of either treatment.ConclusionsIn this small, short-term study, diclofenac was able to improve symptoms and reduce pain during tendon loading in participants with CAT, whereas placebo gel was not. A future study of diclofenac as a supplement to rehabilitation, with longer follow-up and powered to detect a difference between diclofenac and placebo, is indicated.Trial registrationISRCTN60151284, http://www.isrctn.com/ISRCTN60151284 ETHICS: UBC Clinical Research Ethics Board approval was obtained for this research. The certificate number of the ethics certificate of approval to conduct research is H15-00999.

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Dataset Information

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

Objectives

Methods

Results

Discussion

Trial registration

Publications

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

Similar Datasets

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