Allsop Vivianne L, Schmid Arlene A, Miller Kristine K, Slaven James E, Daggy Joanne K, Froman Amanda, Kline Matthew, Sargent Christy, French Dustin D, Ang Dennis, Van Puymbroeck Marieke, Schalk Nancy L, Bair Matthew J
Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, United States.
Department of Occupational Therapy, Colorado State University, Fort Collins, CO, United States.
Front Pain Res (Lausanne). 2022 Jul 7;3:934689. doi: 10.3389/fpain.2022.934689. eCollection 2022.
Fibromyalgia is a common pain condition that often leads to significant disability. Unfortunately, the effectiveness of most medications for fibromyalgia is limited, and there is a need for alternative, non-pharmacological therapies. Yoga and aerobic exercise are both evidence-based non-pharmacological treatments for fibromyalgia. However, no prior studies have directly compared the effectiveness of yoga vs. exercise.
This article describes the study design and recruitment outcomes of the Pain Outcomes comparing Yoga vs. Structured Exercise (POYSE) Trial, a two-arm randomized comparative effectiveness trial.
Veterans with fibromyalgia, defined by the 2010 American College of Rheumatology diagnostic criteria, who also experienced at least moderate pain severity were enrolled. The participants were randomized to a 12-week yoga-based or a structured exercise program (SEP) and will undergo comprehensive outcome assessments at baseline, 1, 3, 6, and 9 months by interviewers blinded to treatment assignment. The primary outcome will be the overall severity of fibromyalgia as measured by the total Fibromyalgia Impact Questionnaire-Revised. Secondary outcomes included depression, anxiety, health-related quality of life, pain beliefs, fatigue, sleep, and self-efficacy.
A total of 2,671 recruitment letters were sent to potential participants with fibromyalgia. Of the potential participants, 623 (23.3%) were able to be contacted by telephone and had their eligibility assessed. Three hundred seventy-one of those interviewed were found to be eligible (59.6%) and 256 (69.0%) agreed to participate and were randomized to the YOGA ( = 129) or the SEP ( = 127) arm of the trial.
Clinicians are faced with numerous challenges in treating patients with fibromyalgia. The interventions being tested in the POYSE trial have the potential to provide primary care and other care settings with new treatment options for clinicians while simultaneously providing a much needed relief for patients suffering from fibromyalgia.
Funded by VA Rehabilitation Research and Development (D1100-R); Trial registration: ClinicalTrials.gov, NCT01797263.
纤维肌痛是一种常见的疼痛病症，常导致严重残疾。不幸的是，大多数治疗纤维肌痛的药物效果有限，因此需要替代性的非药物疗法。瑜伽和有氧运动都是针对纤维肌痛的循证非药物治疗方法。然而，此前尚无研究直接比较瑜伽与运动的效果。
本文描述了疼痛结局比较瑜伽与结构化运动（POYSE）试验的研究设计和招募结果，这是一项双臂随机对照有效性试验。
纳入符合2010年美国风湿病学会诊断标准且疼痛程度至少为中度的纤维肌痛退伍军人。参与者被随机分配到为期12周的瑜伽组或结构化运动项目（SEP）组，并将在基线、第1、3、6和9个月接受对治疗分配不知情的访谈者进行的全面结局评估。主要结局将是通过修订后的纤维肌痛影响问卷总分衡量的纤维肌痛总体严重程度。次要结局包括抑郁、焦虑、健康相关生活质量、疼痛信念、疲劳、睡眠和自我效能感。
共向潜在的纤维肌痛参与者发送了2671封招募信。在这些潜在参与者中，623人（23.3%）能够通过电话联系并接受资格评估。其中371名接受访谈者被认定符合资格（59.6%），256人（69.0%）同意参与并被随机分配到试验的瑜伽组（n = 129）或SEP组（n = 127）。
临床医生在治疗纤维肌痛患者时面临诸多挑战。POYSE试验中正在测试的干预措施有可能为初级保健和其他护理环境中的临床医生提供新的治疗选择，同时为纤维肌痛患者提供急需的缓解。
由美国退伍军人事务部康复研究与发展处资助（D1100 - R）；试验注册：ClinicalTrials.gov，NCT01797263。
