Levey Nadine, Chen Neal, Ditre Joseph, Sylvia Louisa, Mudgal Chaitanya, Bhashyam Abhiram, Garg Rohit, Ring David, Vranceanu Ana-Maria, Bakhshaie Jafar
Center for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States.
Hand and Arm Center, Department of Orthopedic Surgery, Massachusetts General Hospital, Boston, MA, United States.
JMIR Res Protoc. 2024 Dec 9;13:e64547. doi: 10.2196/64547.
Nontraumatic painful upper-extremity conditions (NPUCs) are largely age-related degenerations that affect the majority of adults. Most patients with NPUCs do not seek medical care and adjust on their own. Among those who do seek care, approximately 20% report risky substance use, defined as a consumption pattern that increases the risk of harm to physical or psychosocial health. In the context of NPUC, risky substance use is associated with more intense pain, emotional distress, disability, and opioid or other substance misuse (ie, cross-tolerance). Consequently, risky substance use is a significant modifiable risk factor for the progression and maintenance of chronic pain-related disability and comorbid psychopathology among patients with NPUCs.
This study aims to develop, adapt, and test the feasibility of the Web-Based Toolkit for Resilient Life Beyond Pain and Substance Use (Web-TIRELESS), a novel, asynchronous, and web-based mind-body intervention aimed at modifying maladaptive pain-coping behaviors in patients with NPUC and comorbid risky substance use. This study illustrates the proposed study design, methodology, and intervention content.
In aim 1, we will conduct live video qualitative interviews (n=20) with care-seeking adult patients with NPUC and comorbid risky substance use to inform the development and refinement of Web-TIRELESS and study procedures. In aim 2, we propose an open pilot study (n=12) of Web-TIRELESS with exit interviews and pre- and postintervention assessments to evaluate the feasibility, credibility, and acceptability of Web-TIRELESS and refine study procedures. Aim 3 consists of a pilot feasibility randomized controlled trial of Web-TIRELESS versus minimally enhanced usual care (n=50), both of which follow a web-based modality, to demonstrate the feasibility of recruitment procedures and data collection, as well as the feasibility, credibility, and acceptability of Web-TIRELESS and the control condition (adherence, retention, fidelity, and satisfaction), following prespecified benchmarks.
Patient interviews (aim 1) concluded in May 2024 and qualitative analysis is expected to be completed in September 2024. Completion of aim 2 (data collection and analysis) is expected by June 2025. The completion of aim 3 and other study-related operations is anticipated by June 2027.
We will develop and test Web-TIRELESS, the first asynchronous mind-body intervention specifically adapted to enhance resilience in response to chronic pain among individuals with NPUCs and comorbid risky substance use. Results from this 3-aim study (feasibility, acceptability, and satisfaction of Web-TIRELESS) will be leveraged to inform a future efficacy randomized controlled trial of Web-TIRELESS versus the minimally enhanced usual care.
ClinicalTrials.gov NCT06366633; https://clinicaltrials.gov/study/NCT06366633.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/64547.
非创伤性上肢疼痛病症（NPUCs）主要是与年龄相关的退化性疾病，影响着大多数成年人。大多数NPUCs患者不寻求医疗护理，而是自行调整。在那些寻求治疗的患者中，约20%报告有危险物质使用情况，危险物质使用被定义为一种增加对身体或心理社会健康造成伤害风险的消费模式。在NPUC的背景下，危险物质使用与更强烈的疼痛、情绪困扰、残疾以及阿片类药物或其他物质滥用（即交叉耐受性）相关。因此，危险物质使用是NPUCs患者慢性疼痛相关残疾和共病心理病理学进展及维持的一个重要可改变风险因素。
本研究旨在开发、改编并测试基于网络的超越疼痛和物质使用的复原力工具包（Web-TIRELESS）的可行性，这是一种新颖的、异步的、基于网络的身心干预措施，旨在改变NPUC和共病危险物质使用患者适应不良的疼痛应对行为。本研究阐述了拟议的研究设计、方法和干预内容。
在目标1中，我们将对寻求治疗的患有NPUC和共病危险物质使用的成年患者进行现场视频定性访谈（n = 20），以为Web-TIRELESS的开发和完善以及研究程序提供信息。在目标2中，我们提议对Web-TIRELESS进行开放试点研究（n = 12），包括退出访谈以及干预前和干预后评估，以评估Web-TIRELESS的可行性、可信度和可接受性，并完善研究程序。目标3包括Web-TIRELESS与最低限度强化常规护理（n = 50）的试点可行性随机对照试验，两者均采用基于网络的方式，以证明招募程序和数据收集的可行性，以及Web-TIRELESS和对照条件（依从性、保留率、保真度和满意度）在预先设定基准下的可行性、可信度和可接受性。
患者访谈（目标1）于2024年5月结束，定性分析预计于2024年9月完成。预计到2025年6月完成目标2（数据收集和分析）。预计到2027年6月完成目标3和其他与研究相关的操作。
我们将开发并测试Web-TIRELESS，这是首个专门为增强NPUCs和共病危险物质使用个体应对慢性疼痛的复原力而改编的异步身心干预措施。这项三目标研究（Web-TIRELESS的可行性、可接受性和满意度）的结果将用于为未来Web-TIRELESS与最低限度强化常规护理的疗效随机对照试验提供信息。
ClinicalTrials.gov NCT06366633；https://clinicaltrials.gov/study/NCT06366633。
国际注册报告标识符（IRRID）：DERR1-10.2196/64547。
