Browne Jonathan D, Vaninetti Michael, Giard David, Kostas Konstantinos, Dave Ankur
School of Medicine, California University of Science and Medicine, Colton, CA, United States.
Center for Pain Medicine, University of California San Diego, La Jolla, CA, United States.
JMIR Form Res. 2022 Oct 13;6(10):e40869. doi: 10.2196/40869.
Chronic low back pain is challenging to manage due to multidisciplinary considerations. It has substantial socioeconomic impacts and cannot be simply treated with pharmacotherapy, nonsurgical intervention, or spine surgery. Medical consensus recommends optimizing conservative self-management therapies (eg, home exercise, wellness strategies, yoga, etc) as first-line treatment options for chronic low back pain. However, access to these modalities is often limited and secondary to cost, convenience, and ease of use. Mobile health apps have emerged as a cost-effective and accessible option for chronic low back pain self-management. Established in-person pain programs can provide the structure for an optimal mobile app adaptation. PainNavigator (PainNavigator, Inc) is an example of a mobile app that is based on an Ascension-Illinois group-based pain program-Pain Rehabilitation Outpatient-Camp.
This was a prospective pilot clinical trial that evaluated the PainNavigator platform's utility in low back pain management to inform future trial development.
A total of 75 participants who used PainNavigator were studied. Pain, Enjoyment, and General Activity (PEG-3) scale scores and scores from a brief anxiety and depression scale based on the Patient Health Questionnaire-4 (PHQ-4) were obtained at baseline and following program completion. The PEG-3 total score was used, in addition to individual items-Average Pain, Pain Effect on Enjoyment, and Pain Effect on Activity. The PHQ-4 total score was also used, in addition to other individual items, including Felt Depressed, Loss of Interest, Felt Anxious, and Difficult to Control Worry. Paired sample t tests (2-tailed) compared mean differences in scores from before and after participants received the intervention.
The analysis found that PEG-3 (n=27) and PHQ-4 (n=27) total scores were significantly lower upon the completion of PainNavigator (P<.001 and P=.001, respectively). The findings showed a 36% reduction in PEG-3 total scores, a 40% reduction in pain intensity, and a 40% reduction in PHQ-4 total scores. Scores for individual PEG-3 scale and PHQ-4 items also significantly decreased. All PEG-3 measures had large effect sizes. The PHQ-4 total score and Difficult to Control Worry item had large effect sizes, while the other three measures had medium effect sizes.
These findings show that PainNavigator has clinical significance in managing chronic low back pain and can be easily utilized to improve patient care. All PEG-3 scale and PHQ-4 measures significantly improved following the use of the platform, supporting the multidimensional, biopsychosocial approach to low back pain management. Differences in effect sizes may inform quality improvement investigations, such as optimizing features that impact measures with only medium effect sizes. This feasibility study demonstrates an effective protocol, and it will inform future, more extensive randomized controlled trials.
由于多学科因素的考量，慢性下腰痛的管理颇具挑战性。它具有重大的社会经济影响，无法单纯通过药物治疗、非手术干预或脊柱手术来解决。医学共识建议将优化保守的自我管理疗法（如家庭锻炼、健康策略、瑜伽等）作为慢性下腰痛的一线治疗选择。然而，获得这些治疗方式的机会往往有限，且受成本、便利性和易用性等因素的限制。移动健康应用程序已成为慢性下腰痛自我管理的一种经济高效且易于获取的选择。已有的面对面疼痛管理项目可为优化移动应用程序提供框架。PainNavigator（PainNavigator公司）就是一款基于阿森松 - 伊利诺伊州团体疼痛管理项目——疼痛康复门诊 - 训练营的移动应用程序。
这是一项前瞻性试点临床试验，旨在评估PainNavigator平台在腰痛管理中的效用，为未来试验的开展提供参考。
共对75名使用PainNavigator的参与者进行了研究。在基线期和项目结束后，获取疼痛、愉悦感和日常活动（PEG - 3）量表评分以及基于患者健康问卷 - 4（PHQ - 4）的简短焦虑和抑郁量表评分。除了个体项目——平均疼痛、疼痛对愉悦感的影响以及疼痛对活动的影响外，还使用了PEG - 3总分。除了其他个体项目，包括感到抑郁、失去兴趣、感到焦虑以及难以控制担忧外，还使用了PHQ - 4总分。采用配对样本t检验（双侧）比较参与者接受干预前后评分的平均差异。
分析发现，完成PainNavigator后，PEG - 3（n = 27）和PHQ - 4（n = 27）的总分显著降低（分别为P <.001和P =.001）。结果显示PEG - 3总分降低了36%，疼痛强度降低了40%，PHQ - 4总分降低了40%。PEG - 3量表和PHQ - 4项目的个体评分也显著下降。所有PEG - 3指标的效应量都很大。PHQ - 4总分和难以控制担忧项目的效应量很大，而其他三项指标的效应量为中等。
这些结果表明，PainNavigator在慢性下腰痛的管理中具有临床意义，且易于用于改善患者护理。使用该平台后，所有PEG - 3量表和PHQ - 4指标均有显著改善，支持了对下腰痛管理采取的多维度、生物心理社会方法。效应量的差异可为质量改进研究提供参考，例如优化对效应量仅为中等的指标有影响的功能。这项可行性研究展示了一个有效的方案，并将为未来更广泛的随机对照试验提供参考。
