Baxter George David, Liu Lizhou, Tumilty Steve, Petrich Simone, Chapple Cathy, Anders Juanita J
Centre for Health, Activity and Rehabilitation Research, School of Physiotherapy, University of Otago, Dunedin, New Zealand.
Department of Surgical Sciences, Southern District Health Board, Dunedin, New Zealand.
Lasers Surg Med. 2018 Sep;50(9):924-932. doi: 10.1002/lsm.22947. Epub 2018 May 30.
This study aimed to determine the feasibility of conducting a full scale randomized controlled trial investigating the effectiveness of low level laser therapy (LLLT), also known as photobiomodulation (PBM) therapy, used in addition to conventional therapy, for managing breast cancer related lymphedema (BCRL).
Patients with BCRL were recruited from the Southern District Health Board (New Zealand) via lymphedema therapists' referrals, and randomly allocated into either the laser group, which received BCRL conventional therapy (e.g., wearing compression garments, massage therapy, and/or exercise) plus a 6-week LLLT (PBM) intervention program (wavelength: 980/810 nm (80:20 ratio); output power: 500 mW beam spot size: 5 cm ; irradiance: 100 mW/cm ; treatment time per area: 1 minute dosage per area treated: 30J (6J/cm ); 10 points of treatment from axilla to wrist total LLLT (PBM) treatment time: 10 minutes total dosage delivered: 300 J), or the control group, which received BCRL conventional therapy alone. Feasibility was determined by recruitment and randomization rates, retention of participants and treatment protocol adherence, and was assessed during the recruiting and intervention periods. Data on participant satisfaction and adverse reactions of LLLT (PBM) were collected on completion of this study. Clinical outcomes (i.e., limb circumference, participant's perceived symptoms, psychological impacts, and activity disability) were assessed at baseline, and 6 and 12 weeks post-randomization.
Over a 6-month recruitment window, 17 participants with BCRL were recruited in the study, and randomized into the two groups (recruitment rate of 81%, and randomization rate of 100%). Treatment adherence was high in the laser group (88.9% of participants completed all treatments). Retention rates were 88.9% for the laser group and 100% for the control group at both 6 and 12 weeks post-randomization. All participants who completed LLLT (PBM) treatment indicated that they were satisfied with the treatment. No serious adverse reactions were reported in this study. Clinical outcomes failed to show additional benefits of LLLT (PBM) intervention.
This study demonstrated that it is feasible to conduct a fully powered RCT to definitively test the effectiveness of the additional use of LLLT (PBM) in the management of BCRL. For such a trial, 114 participants will be needed at baseline. Lasers Surg. Med. 50:924-932, 2018. © 2018 Wiley Periodicals, Inc.
本研究旨在确定开展一项全面随机对照试验的可行性，该试验旨在研究低强度激光疗法（LLLT），也称为光生物调节（PBM）疗法，在常规治疗基础上用于管理乳腺癌相关淋巴水肿（BCRL）的有效性。
通过淋巴水肿治疗师的转诊，从新西兰南区卫生局招募BCRL患者，并随机分为激光组和对照组。激光组接受BCRL常规治疗（如穿着压力衣、按摩疗法和/或运动）加为期6周的LLLT（PBM）干预方案（波长：980/810nm（80:20比例）；输出功率：500mW；光斑尺寸：5cm；辐照度：100mW/cm；每个区域治疗时间：1分钟；每个治疗区域剂量：30J（6J/cm）；从腋窝到手腕共10个治疗点；LLLT（PBM）总治疗时间：10分钟；总输送剂量：300J），对照组仅接受BCRL常规治疗。通过招募和随机分组率、参与者留存率和治疗方案依从性来确定可行性，并在招募和干预期间进行评估。在本研究完成时收集参与者对LLLT（PBM）的满意度和不良反应数据。在基线、随机分组后6周和12周评估临床结局（即肢体周长、参与者感知症状、心理影响和活动能力障碍）。
在6个月的招募期内，17名BCRL患者被纳入研究并随机分为两组（招募率为81%，随机分组率为100%）。激光组治疗依从性高（88.9%的参与者完成了所有治疗）。随机分组后6周和12周，激光组的留存率为88.9%，对照组为100%。所有完成LLLT（PBM）治疗的参与者均表示对治疗满意。本研究未报告严重不良反应。临床结局未显示LLLT（PBM）干预有额外益处。
本研究表明开展一项充分有力的随机对照试验以明确测试额外使用LLLT（PBM）治疗BCRL的有效性是可行的。对于这样一项试验，基线时需要114名参与者。《激光外科与医学》50:924 - 932，2018年。©2018威利期刊公司
