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多模式慢性疼痛治疗成人智能手机:随机对照临床试验。

Multimodal Chronic Pain Therapy for Adults via Smartphone: Randomized Controlled Clinical Trial.

机构信息

Primary Care, Andalusian Health Service, Algeciras, Spain.

Primary Care, Andalusian Health Service, Motril, Spain.

出版信息

J Med Internet Res. 2022 May 11;24(5):e36114. doi: 10.2196/36114.

DOI:10.2196/36114
PMID:35373776
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9133987/
Abstract

BACKGROUND

Combination therapies delivered remotely via the internet or mobile devices are increasingly being used to improve and promote the self-management of chronic conditions. However, little is known regarding the long-term effects of these interventions.

OBJECTIVE

The aim of this study is to evaluate the effectiveness of a multimodal intervention program that measures associated variables such as catastrophizing, pain acceptance, and quality of life using a mobile device in people with chronic pain in an outpatient setting.

METHODS

A randomized controlled clinical trial was performed using parallel treatment groups. A total of 209 patients with chronic musculoskeletal pain were randomly assigned to one of the two study arms. The intervention group received a standard web-based psychosocial therapy-type program of activities through a smartphone for 6 weeks. The control group only had access to the Find out more section of the app, which contained audiovisual material for pain management based on a self-help approach. The primary outcome was catastrophizing measured using the Pain Catastrophizing Scale (PCS). Secondary outcomes were pain acceptance measured using the Chronic Pain Acceptance Questionnaire and health-related quality of life measured using the EuroQol Visual Analogue Scale. Assessments were conducted at baseline (T1), after treatment (T2), and at the 3-month follow-up (T3). The variations between the different phases were assessed using the percentage change rescaled with log base 2. The Cohen d was calculated based on the results of the linear mixed model. The investigators of the study who evaluated the results were not involved in patient recruitment and were blinded to the group assignment.

RESULTS

Positive effects were found in the intervention group (T2-T1) in catastrophizing between the baseline and posttreatment phases (P<.001) and in helplessness (-0.72 vs 0.1; P=.002), rumination (-1.59 vs -0.53; P<.001), acceptance (0.38 vs 0.05; P=.001), and quality of life (0.43 vs -0.01; P=.002), although no significant changes were found for magnification (0.2 vs 0.77; P=.14) and satisfaction with health (0.25 vs -0.27; P=.13). Three months after treatment, significant differences were observed in the intervention group for the outcome variable of catastrophizing (PCS; -0.59 vs 0.2; P=.006) and the PCS subscales of helplessness (-0.65 vs 0.01; P=.07), rumination (1.23 vs -0.59; P=.04), and magnification (0.1 vs 0.86; P=.02).

CONCLUSIONS

The results of our study suggest that app-based mobile multidimensional treatments for adults with chronic pain improve catastrophizing, quality of life, and psychological flexibility immediately after treatment and that the effects are maintained for the primary outcome of catastrophizing for at least 3 months following treatment. Moreover, they promote self-management and can be used to complement face-to-face pain treatments.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04509154; https://clinicaltrials.gov/ct2/show/NCT04509154.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c6b0/9133987/0fab80b5efde/jmir_v24i5e36114_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c6b0/9133987/0fab80b5efde/jmir_v24i5e36114_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c6b0/9133987/0fab80b5efde/jmir_v24i5e36114_fig1.jpg
摘要

背景

通过互联网或移动设备远程提供的联合疗法越来越多地用于改善和促进慢性病的自我管理。然而,对于这些干预措施的长期效果知之甚少。

目的

本研究旨在评估一种多模式干预方案的有效性,该方案通过移动设备测量与慢性疼痛患者相关的变量,如灾难化、疼痛接受度和生活质量,该方案在门诊环境中使用。

方法

采用平行治疗组进行随机对照临床试验。共有 209 名患有慢性肌肉骨骼疼痛的患者被随机分配到两个研究组之一。干预组通过智能手机接受为期 6 周的基于网络的心理社会治疗类型的活动标准方案。对照组仅可以访问应用程序的“了解更多”部分,该部分包含基于自助方法的疼痛管理的视听材料。主要结局指标是使用疼痛灾难化量表(PCS)测量的灾难化。次要结局指标是使用慢性疼痛接受问卷测量的疼痛接受度和使用 EuroQol 视觉模拟量表测量的健康相关生活质量。在基线(T1)、治疗后(T2)和 3 个月随访(T3)时进行评估。使用以 2 为底取对数的百分比变化来评估不同阶段之间的差异。根据线性混合模型的结果计算 Cohen d。参与研究结果评估的研究人员未参与患者招募,对分组分配不知情。

结果

干预组(T2-T1)在基线和治疗后阶段的灾难化(P<.001)和无助(-0.72 对 0.1;P=.002)、反刍(-1.59 对-0.53;P<.001)、接受(0.38 对 0.05;P=.001)和生活质量(0.43 对-0.01;P=.002)方面均显示出积极效果,而在放大(0.2 对 0.77;P=.14)和健康满意度(0.25 对-0.27;P=.13)方面则没有显著变化。治疗 3 个月后,干预组在灾难化(PCS;-0.59 对 0.2;P=.006)和无助(-0.65 对 0.01;P=.07)、反刍(1.23 对-0.59;P=.04)和放大(0.1 对 0.86;P=.02)的 PCS 子量表方面的结局变量存在显著差异。

结论

我们的研究结果表明,针对慢性疼痛成年人的基于应用程序的移动多维治疗可在治疗后立即改善灾难化、生活质量和心理灵活性,并且至少在治疗后 3 个月内,灾难化的主要结局仍保持不变。此外,它们促进自我管理,可以用于补充面对面的疼痛治疗。

试验注册

ClinicalTrials.gov NCT04509154;https://clinicaltrials.gov/ct2/show/NCT04509154.

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