背景:脊柱手法治疗(SMT)通常用于治疗肌肉骨骼疾病,包括胸椎疼痛.应用患者特定的力-时间特征被认为对提高SMT的有效性很重要。将SMT作为多模式方法的一部分进行研究对于解决脊椎指压疗法临床实践的复杂性至关重要。因此,需要务实的调查在确保严格协议的稳健数据质量的同时平衡对临床遭遇的最小中断。因此,需要初步研究来评估研究方案,记录数据的质量和此类调查的可持续性。因此,这项研究探讨了在临床环境中研究SMT力-时间特征和临床结局指标的可行性.
方法:在这项混合方法研究中,提供者记录了在常规临床接触期间给予胸椎痛患者的胸部SMT力-时间特征。自我报告疼痛的临床结果,刚度,SMT期间的舒适度(使用电子视觉模拟量表),并在每次SMT应用前后测量变化量表的全球评级。对参与者招募的可行性进行了定量评估,数据收集和数据质量。定性数据评估了参与者对数据收集对患者管理和临床流程的影响的看法。
结果:12名提供者(58%为女性,27.3±5.0岁)和12名患者(58%为女性,37.2±14.0岁)参加研究。入学率大于40%,数据收集率为49%,错误数据少于5%。参与者的接受度很好,提供者和患者都报告了研究的积极经验。
结论:在临床接触期间记录SMT力-时间特征和自我报告的临床结果指标可能是可行的,并对当前方案进行了具体修改。研究方案对患者管理没有负面影响。正在开发优化数据收集协议以开发大型临床数据库的特定策略。
Spinal manipulative therapy (SMT) is commonly used to treat musculoskeletal conditions, including thoracic spine pain. Applying patient-specific force-time characteristics are believed to be important to improve SMT\'s effectiveness. Investigating SMT as part of a multimodal approach is fundamental to account for the complexity of chiropractic clinical practice. Therefore, pragmatic investigations balancing minimal disruptions to the clinical encounter at the same time as ensuring a robust data quality with rigorous protocols are needed. Consequently, preliminary studies are required to assess the study protocol, quality of data recorded and the sustainability of such investigation. Therefore, this study examined the feasibility of investigating SMT force-time characteristics and clinical outcome measures in a clinical setting.
In this mixed-methods study, providers recorded thoracic SMT force-time characteristics delivered to patients with thoracic spinal pain during regular clinical encounters. Self-reported clinical outcomes of pain, stiffness, comfort during the SMT (using an electronic visual analogue scale), and global rating of change scale were measured before and after each SMT application. Feasibility was quantitatively assessed for participant recruitment, data collection and data quality. Qualitative data assessed participants\' perceptions on the impact of data collection on patient management and clinical flow.
Twelve providers (58% female, 27.3 ± 5.0 years old) and twelve patients (58% female, 37.2 ± 14.0 years old) participated in the study. Enrolment rate was greater than 40%, data collection rate was 49% and erroneous data was less than 5%. Participant acceptance was good with both providers and patients reporting positive experience with the study.
Recording SMT force-time characteristics and self-reported clinical outcome measures during a clinical encounter may be feasible with specific modification to the current protocol. The study protocol did not negatively impact patient management. Specific strategies to optimize the data collection protocol for the development of a large clinical database are being developed.