Department of Public Health, Swansea University, Swansea, UK.
Division of Psychological Medicine and Clinical Neurosciences, School of Medicine, Cardiff University, Cardiff, CF10 3AT, UK.
Chiropr Man Therap. 2024 Nov 6;32(1):32. doi: 10.1186/s12998-024-00556-x.
The increasing prevalence of mental health disorders in the United Kingdom necessitates the exploration of novel treatment modalities. This study aimed to assess the feasibility and acceptability of conducting a randomised controlled trial (RCT) evaluating the efficacy of four osteopathic interventions on psychophysiological and mental health outcomes.
A mixed-methods feasibility study with an explanatory sequential design was implemented. The quantitative phase involved randomising 42 participants into four intervention groups: (1) high-velocity and articulation techniques (HVAT), (2) soft-tissue massage (STM), (3) craniosacral therapy (CST), and (4) a combination approach. Primary outcome measures encompassed recruitment rate, assessment duration, questionnaire completion, intervention attrition, and adverse events. Secondary outcomes included validated assessments of depression, anxiety, stress, psychological flexibility, heart rate variability (HRV), and interoception, administered pre- and post-intervention. Analysis of variance (ANOVA) was employed to evaluate pre-post intervention changes. The qualitative phase comprised semi-structured interviews analysed using thematic analysis.
The study achieved a recruitment rate of 21 eligible participants per month, with 54.8% of respondents meeting eligibility criteria. All 33 participants who completed the study underwent interventions and assessments within the allocated one-hour timeframe, with full questionnaire completion. The attrition rate was 21%. No adverse events were reported. Qualitative analysis revealed positive participant experiences, with themes highlighting good practitioner communication, intervention accessibility, and increased bodily awareness. Some participants found the questionnaire battery burdensome. Exploratory quantitative analyses showed variations in effects across interventions for heart rate variability, interoceptive accuracy, and mental health measures, but these results should be interpreted cautiously due to the small sample size.
This study provides evidence supporting the feasibility and acceptability of a larger-scale RCT investigating osteopathic interventions for individuals presenting with mild psychological symptoms. The preliminary findings suggest potential efficacy in improving mental health outcomes, warranting further investigation. Trial registration NCT05674071, registered 06/01/2023.
心理健康障碍在英国的患病率不断上升，需要探索新的治疗方法。本研究旨在评估评估四种整骨干预措施对心理生理和心理健康结果的疗效的随机对照试验 (RCT) 的可行性和可接受性。
采用混合方法可行性研究，设计为解释性序贯设计。定量阶段将 42 名参与者随机分为四组干预组：(1)高速度和关节技术 (HVAT)，(2)软组织按摩 (STM)，(3)颅骶疗法 (CST)，和 (4) 联合方法。主要结局指标包括招募率、评估持续时间、问卷完成情况、干预脱落率和不良事件。次要结局包括抑郁、焦虑、压力、心理灵活性、心率变异性 (HRV) 和内脏感知的验证评估，在干预前后进行。采用方差分析 (ANOVA) 评估干预前后的变化。定性阶段包括使用主题分析进行半结构化访谈。
该研究每月达到 21 名合格参与者的招募率，其中 54.8%的受访者符合入选标准。所有完成研究的 33 名参与者均在分配的一小时内接受了干预和评估，并完成了完整的问卷。脱落率为 21%。没有报告不良事件。定性分析显示参与者的体验积极，主题突出了良好的从业者沟通、干预的可及性和身体意识的提高。一些参与者发现问卷电池负担过重。探索性定量分析显示，心率变异性、内脏感知准确性和心理健康测量指标的干预效果存在差异，但由于样本量小，这些结果应谨慎解释。
本研究为进一步调查整骨干预治疗轻度心理症状个体提供了可行性和可接受性的证据。初步结果表明，改善心理健康结果的潜在疗效，值得进一步研究。试验注册 NCT05674071，于 2023 年 6 月 1 日注册。
