治疗师提供的按摩与护理伙伴辅助按摩对慢性颈部疼痛退伍军人的疗效：一项随机对照试验方案

Therapist-Delivered Versus Care Ally-Assisted Massage for Veterans With Chronic Neck Pain: Protocol for a Randomized Controlled Trial.

作者信息

Munk Niki, Daggy Joanne K, Evans Erica, Kline Matthew, Slaven James E, Laws Brian, Foote Trevor, Matthias Marianne S, Bair Matthew J

机构信息

Department of Health Sciences, School of Health and Human Sciences, Indiana University, Indianapolis, IN, United States.

Australian Research Centre in Complementary and Integrative Medicine, Massage & Myotherapy Australia Fellow and Visiting Faculty of Health, University of Technology Sydney, Sydney, Australia.

出版信息

JMIR Res Protoc. 2022 Sep 27;11(9):e38950. doi: 10.2196/38950.

DOI:10.2196/38950

PMID:36166287

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9555333/

Abstract

BACKGROUND

Chronic neck pain (CNP) is prevalent, and it reduces functional status and quality of life and is associated with deleterious psychological outcomes in affected individuals. Despite the desirability of massage and its demonstrated effectiveness in CNP treatment, multiple accessibility barriers exist. Caregiver-applied massage has demonstrated feasibility in various populations but has not been examined in Veterans with CNP or compared in parallel to therapist-delivered massage.

OBJECTIVE

This manuscript described the original study design, lessons learned, and resultant design modifications for the Trial Outcomes for Massage: Care Ally-Assisted Versus Therapist-Treated (TOMCATT) study.

METHODS

TOMCATT began as a 3-arm, randomized controlled trial of 2 massage delivery approaches for Veterans with CNP with measures collected at baseline, 1 and 3 months after intervention, and 6 months (follow-up). Arm I, care ally-assisted massage, consisted of an in-person, 3.5-hour training workshop, an instructional DVD, a printed treatment manual, and three 30-minute at-home care ally-assisted massage sessions weekly for 3 months. Arm II, therapist-treated massage, consisted of two 60-minute sessions tailored to individual pain experiences and treatments per week for 3 months. The treatments followed a standardized Swedish massage approach. Arm III consisted of wait-list control.

RESULTS

Retention and engagement challenges in the first 30 months were significant in the care ally-assisted massage study arm (63% attrition between randomization and treatment initiation) and prompted modification to a 2-arm trial, that is, removing arm I.

CONCLUSIONS

The modified TOMCATT study successfully launched and exceeded recruitment goals 2.5 months before the necessary COVID-19 pause and is expected to be completed by early 2023.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03100539; https://clinicaltrials.gov/ct2/show/NCT03100539.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38950.

摘要

背景

慢性颈部疼痛（CNP）很常见，它会降低功能状态和生活质量，并与受影响个体的不良心理结果相关。尽管按摩很受欢迎且在CNP治疗中已证明有效，但存在多种可及性障碍。由护理人员实施的按摩在不同人群中已证明具有可行性，但尚未在患有CNP的退伍军人中进行研究，也未与治疗师提供的按摩进行平行比较。

目的

本手稿描述了“按摩试验结果：护理伙伴辅助与治疗师治疗对比（TOMCATT）”研究的原始研究设计、经验教训以及由此产生的设计修改。

方法

TOMCATT最初是一项针对患有CNP的退伍军人的2种按摩实施方法的三臂随机对照试验，在基线、干预后1个月和3个月以及6个月（随访）时收集数据。第一组，护理伙伴辅助按摩，包括一次3.5小时的面对面培训工作坊、一张教学DVD、一本印刷的治疗手册，以及为期3个月每周三次30分钟的在家护理伙伴辅助按摩疗程。第二组，治疗师治疗按摩，包括根据个体疼痛经历和治疗量身定制的每周两次60分钟疗程，为期3个月。治疗采用标准化的瑞典按摩方法。第三组为等待名单对照组。