全身光生物调节疗法治疗纤维肌痛:一项可行性试验。
Whole-Body Photobiomodulation Therapy for Fibromyalgia: A Feasibility Trial.
作者信息
Fitzmaurice Bethany C, Heneghan Nicola R, Rayen Asius T A, Grenfell Rebecca L, Soundy Andrew A
机构信息
Department of Pain Management, Sandwell and West Birmingham NHS Trust, Birmingham B71 4HJ, UK.
School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham B15 2TT, UK.
出版信息
Behav Sci (Basel). 2023 Aug 29;13(9):717. doi: 10.3390/bs13090717.
Effective treatment for fibromyalgia (FM) is lacking and further treatment options are needed. Photobiomodulation therapy (PBMT) represents one potential treatment option. Whilst favourable findings have been reported using localised PBMT, no investigations have established the value of whole-body PBMT for the complete set of symptom domains in FM. A single-arm feasibility study was conducted in accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines. A non-probability sampling method was used to access individuals with FM. The primary outcome measure was identified as the Revised Fibromyalgia Impact Questionnaire (FIQR). Forty-nine participants were screened and twenty-one trial participants entered the trial. Nineteen participants completed the intervention (18 whole-body PBMT sessions over approximately six weeks). Descriptive statistics and qualitative analysis was undertaken to represent feasibility outcomes. Acceptability of the trial device and processes were established. Outcome measures towards efficacy data were guided by core and peripheral OMERACT (outcomes measures in rheumatological clinical trials) domains, utilising a combination of participant-reported and performance-based outcome measures. Data for the embedded qualitative component of the trial were captured by participant-reported experience measures and audio-recorded semi-structured interviews. Positive changes were observed for FM-specific quality of life, pain, tenderness, stiffness, fatigue, sleep disturbance, anxiety, depression and cognitive impairment. Patient global assessment revealed improvements at 6 weeks, with continued effect at 24 weeks. FM-specific quality of life at 24 weeks remained improved compared with baseline scores. The findings provided evidence to support a full-scale trial and showed promise regarding potential efficacy of this novel non-invasive treatment in an FM population.
纤维肌痛(FM)缺乏有效的治疗方法,需要更多的治疗选择。光生物调节疗法(PBMT)是一种潜在的治疗选择。虽然已有使用局部PBMT的有利研究结果报道,但尚无研究证实全身PBMT对FM全套症状领域的价值。本研究按照CONSORT(试验报告统一标准)指南进行了一项单臂可行性研究。采用非概率抽样方法招募FM患者。主要结局指标确定为修订版纤维肌痛影响问卷(FIQR)。共筛查了49名参与者,21名试验参与者进入试验。19名参与者完成了干预(在约六周内进行18次全身PBMT治疗)。采用描述性统计和定性分析来呈现可行性结果。确定了试验设备和流程的可接受性。疗效数据的结局指标以核心和外周OMERACT(风湿病临床试验结局指标)领域为指导,采用参与者报告和基于表现的结局指标相结合的方式。试验嵌入式定性部分的数据通过参与者报告的经验指标和录音半结构化访谈收集。观察到FM特异性生活质量、疼痛、压痛、僵硬、疲劳、睡眠障碍、焦虑、抑郁和认知障碍有积极变化。患者整体评估显示在6周时有所改善,在24周时仍有持续效果。与基线评分相比,24周时FM特异性生活质量仍有所改善。这些发现为支持全面试验提供了证据,并显示了这种新型非侵入性治疗方法在FM患者群体中的潜在疗效前景。