Improving multimodal physical function in adults with heterogeneous chronic pain; Multi-site feasibility RCT

项目摘要 慢性疼痛是昂贵的，具有挑战性的治疗，并与身体功能的实质性损害。轻度体力 诸如步行的活动是安全的，但是参与和坚持是有问题的。IMMPACT标准和ICF框架 建议所有慢性疼痛临床试验评估和目标的身体功能全面使用不仅自我， 报告，而且还基于性能和活动的动态监测（例如，目标）。迄今为止，没有任何临床试验 遵循这些建议。一个适合慢性病患者独特需求的身心计划 肌肉骨骼疼痛，包括活动技能，以帮助个人增加步数使用Fitbit提供 对目标的责任感可以有效地改善身体功能的各个方面。为了开始验证这些假设 我们完成了一个R34 NCCIH资助的项目，在该项目中，我们：1）采用了一个多模态的、以理论为基础的身心计划 (The放松反应恢复力计划; 3RP），以满足慢性非恶性肿瘤患者的独特需求， 肌肉骨骼疼痛，并通过时间目标（GetActive）专门针对增加步行（他们的首选活动） 或通过Fitbit（GetActive-Fitbit）测量和强化的步数目标; 2）完成了一个开放式试点，并进行了离职面谈 和3）对2个项目进行RCT，并确定单个研究中心的可行性、可接受性和 保真度基准包括身体功能测量中的改善的类似信号。直接建立在 在这次成功的试验中，我们现在建议在MGH和另外两个地理位置不同的地区实施多地点试点RCT GetActive-Fitbit的研究中心（Rush和杜克）（从定量和定性方面证明优于GetActive 数据）与健康促进计划（HEP）。我们将建立：1）多站点对培训和协议的忠诚度;以及2） 研究程序的多中心可行性和可接受性，包括招募有利于 大多数来自该计划以及代表美国的种族和少数民族样本（38%，2020年 我们亦会利用职员和参与者提供的定性资料，修订有关的程序， 大型多中心疗效RCT以及随后在慢性疼痛患者常规护理中实施GetActive-Fitbit。

PROJECT SUMMARY Chronic pain is costly, challenging to treat, and associated with substantial impairment in physical function. Mild physical activity such as walking is safe but engagement and adherence are problematic. IMMPACT criteria and the ICF frameworks recommend that all chronic pain clinical trials assess and target physical function comprehensively using not only self- report, but also performance based and ambulatory monitoring of activity (e.g., objective). No clinical trials to date have followed these recommendations. A mind body program adapted for the unique needs of individuals with chronic musculoskeletal pain that incorporates activity skills to help individuals increase step count using a Fitbit to provide accountability to goals may be efficacious in improving all aspects of physical function. To begin testing these hypotheses we completed an R34 NCCIH funded project, in which we: 1) adapted a multimodal, theory grounded mind body program (The Relaxation Response Resilience Program; 3RP) for the unique needs of patients with chronic non-malignant, musculoskeletal pain and to specifically target increased walking (their preferred activity) through time goals (GetActive) or step count goals measured and reinforced by a Fitbit (GetActive-Fitbit); 2) completed an open pilot with exit interviews of the 2 programs; and 3) conducted an RCT of the 2 programs and established single site feasibility, acceptability and fidelity benchmarks including similar signal of improvement in physical function measurements. Directly building upon this successful trial, we now propose a multisite pilot RCT implemented at MGH and 2 additional geographically diverse sites (Rush and Duke) of GetActive-Fitbit (with evidence of superiority over GetActive from quantitative and qualitative data) vs a Health Enhancement Program (HEP). We will establish: 1) multi-site fidelity to training and protocol; and 2) multi-site feasibility and acceptability of study procedures including recruitment of sedentary individuals who benefit the most from this program and a sample of racial and ethnic minorities that is representative of the USA (38%, 2020 numbers) .We will also refine our protocols using qualitative information from staff and participants to set the stage for a large, multi-site efficacy RCT and subsequent implementation of GetActive-Fitbit in routine care of chronic pain patients.