A text messaging intervention to support patients with chronic pain during prescription opioid tapering: protocol for a double-blind randomised controlled trial
Authors: Gholamrezaei Ali , Magee Michael R , McNeilage Amy G , Dwyer Leah , Jafari Hassan , Sim Alison , Ferreira Manuela L , Darnall Beth D , Glare Paul , Ashton-James Claire E 
Published: May 2023

AbstractIntroductionIncreases in pain and interference with quality of life is a common concern among people with chronic non-cancer pain (CNCP) who are tapering opioid medications. Research indicates that access to social and psychological support for pain self-management may help people to reduce their opioid dose without increasing pain and interference. This study evaluates the efficacy of a text messaging intervention designed to provide people with CNCP with social and psychological support for pain self-management while tapering long-term opioid therapy (LTOT) under the guidance of their prescriber.Methods and analysisA double-blind randomised controlled trial will be conducted. Patients with CNCP (n= 220) who are tapering LTOT will be enrolled from across Australia. Participants will continue with their usual care while tapering LTOT under the supervision of their prescribing physician. They will randomly receive either a psycho-educational video and supportive text messaging (two SMS per day) for 12 weeks or the video only. The primary outcome is the pain intensity and interference assessed by the Pain, Enjoyment of Life and General Activity scale. Secondary outcomes include mood, self-efficacy, pain cognitions, opioid dose reduction, withdrawal symptoms, and acceptability, feasibility, and safety of the intervention. Participants will complete questionnaires at baseline and then every four weeks for 12 weeks and will be interviewed at week 12. This trial will provide evidence for the efficacy of a text messaging intervention to support patients with CNCP who are tapering LTOT. If proven to be efficacious and safe, this low-cost intervention can be implemented at scale.Ethics and disseminationThe study protocol was reviewed and approved by the Northern Sydney Local Health District (Australia). Study results will be published in peer-reviewed journals and presented at scientific and professional meetings.Trial registration numberACTRN12622001423707.Strengths and limitations of this studyThis protocol describes a double-blind randomised controlled trial in which patients, clinicians, investigators, outcome assessors, and statistician will all be blind to group allocation.The intervention was co-designed with input from both patients and clinicians and further refined based on feedback received during a pilot study of the intervention.The design and procedures of this trial were informed by the feasibility and potential efficacy measures of a pilot trial.By using a broad community-based sample, this study aims to conduct more inclusive pain research and investigate the barriers and facilitators of implementing digital support on a larger scale.Designing a sham or placebo control that is completely identical to the intervention is a challenge for a digital intervention. The active control may provide benefits to its recipients, potentially leading to an underestimation of the actual effect size of the digital support.