Núcleo de Pesquisa e Inovação em Ciências da Saúde (NUPICS), Universidade Federal de Juiz de Fora, Juiz de Fora, Brazil
Serviço de Ortopedia e Traumatologia, Universidade Federal de Juiz de Fora Hospital Universitário, Juiz de Fora, Brazil.
BMJ Open. 2023 Jan 12;13(1):e069153. doi: 10.1136/bmjopen-2022-069153.
Fibromyalgia is a polysymptomatic syndrome with a prevalence between 0.2% and 13% of the population and causes work disabilities in approximately half of affected patients. Several treatments to fibromyalgia have been proposed with partial improvement. This study aims to evaluate the efficacy of hyperbaric oxygen therapy and when it should be introduced to fibromyalgia.
This is a protocol for an open-label, crossover, randomised clinical trial comparing treatment with hyperbaric oxygen therapy and standardised treatment to fibromyalgia. In the proposed study, 56 individuals with fibromyalgia will be randomised in a 1:1 ratio into a single, fixed, random block, in which one group will receive hyperbaric oxygen therapy and another will receive standard treatment. Subsequently, the groups will be crossed. Participants will be evaluated at baseline, eight and 16 weeks based on functional impairment assessed with the Fibromyalgia Impact Questionnaire-Brazilian Portuguese version, psychopathological symptoms questionnaire and short-form quality of life questionnaire. The improvement of symptoms concerning the moment of therapy used will be compared between groups. For sample size calculation, a moderate effect size, 80% power and 95% CI will be estimated, in a total of 46 patients. Considering a dropout of 20%, 56 patients should be recruited.
The study was approved by the Universidade Federal de Juiz de Fora Teaching Hospital ethics committee and assigned the number 53058421.9.0000.5133 (version 3). The results will be disseminated via publications in peer-reviewed journals and presentations in medical meetings.
RBR-6prps8g)/UTN U1111-1278-3224.
纤维肌痛是一种多症状综合征，其患病率在人群中为 0.2%至 13%，约有一半的患病患者会因此出现工作能力丧失。已经提出了几种纤维肌痛的治疗方法，但都只有部分改善。本研究旨在评估高压氧治疗的疗效，以及何时应将其引入纤维肌痛的治疗中。
这是一项开放标签、交叉、随机临床试验的方案，比较了高压氧治疗和标准化治疗纤维肌痛的疗效。在拟议的研究中，将 56 名纤维肌痛患者随机分为 1:1 比例的单个固定随机块，其中一组接受高压氧治疗，另一组接受标准治疗。随后，两组将进行交叉。参与者将根据 Fibromyalgia Impact Questionnaire-Brazilian Portuguese version、精神病理症状问卷和简短形式生活质量问卷评估的功能障碍，在基线、8 周和 16 周进行评估。将比较两组在使用治疗时症状的改善情况。为了计算样本量，预计在总共有 46 名患者的情况下，将估计中等效应量、80%的功率和 95%的置信区间。考虑到 20%的脱落率，应招募 56 名患者。
该研究得到了 Juiz de Fora 联邦大学教学医院伦理委员会的批准，并分配了编号 53058421.9.0000.5133（第 3 版）。结果将通过发表在同行评议期刊上的文章和在医学会议上的演讲进行传播。
RBR-6prps8g）/UTN U1111-1278-3224。
