短信干预支持慢性疼痛患者在阿片类药物逐渐减量期间：一项双盲随机对照试验方案。

Text messaging intervention to support patients with chronic pain during prescription opioid tapering: protocol for a double-blind randomised controlled trial.

机构信息

Pain Management Research Institute, Kolling Institute, The University of Sydney, Sydney, New South Wales, Australia.

Consumer Advisory Group, Painaustralia, Deakin, Victoria, Australia.

出版信息

BMJ Open. 2023 Oct 24;13(10):e073297. doi: 10.1136/bmjopen-2023-073297.

DOI:10.1136/bmjopen-2023-073297

PMID:37879692

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10603486/

Abstract

INTRODUCTION

Increases 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 ANALYSIS

A double-blind randomised controlled trial will be conducted. Patients with CNCP (n=74) 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 psychoeducational video and supportive text messaging (two Short Message Service (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 4 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 DISSEMINATION

The 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 NUMBER

ACTRN12622001423707.

摘要

简介

在慢性非癌痛（CNCP）患者逐渐减少阿片类药物时，疼痛加剧和生活质量下降是一个常见的问题。研究表明，获得社会和心理支持以进行疼痛自我管理可能有助于人们在不增加疼痛和干扰的情况下减少阿片类药物的剂量。本研究评估了一种短信干预措施的疗效，该措施旨在为逐渐减少长期阿片类药物治疗（LTOT）的 CNCP 患者提供社会和心理支持，以进行疼痛自我管理，同时在其处方医生的指导下进行。

方法和分析

将进行一项双盲随机对照试验。将从澳大利亚各地招募接受 CNCP 治疗并逐渐减少 LTOT 的患者。参与者将继续接受他们的常规护理，同时在他们的处方医生的监督下逐渐减少 LTOT。他们将随机接受一个心理教育视频和支持性短信（每天两条短信），持续 12 周，或仅接受视频。主要结局是通过疼痛、享受生活和一般活动量表评估的疼痛强度和干扰。次要结局包括情绪、自我效能、疼痛认知、阿片类药物剂量减少、戒断症状以及干预的可接受性、可行性和安全性。参与者将在基线时和接下来的每 4 周完成问卷，共 12 周，并在第 12 周进行访谈。该试验将为支持逐渐减少 LTOT 的 CNCP 患者的短信干预措施的疗效提供证据。如果证明是有效且安全的，这种低成本的干预措施可以大规模实施。