Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, People's Republic of China.
Department of Physical Therapy, Health Science Faculty, Albaath University, Homs, Syria.
Trials. 2020 Jul 3;21(1):609. doi: 10.1186/s13063-020-04534-5.
To evaluate the therapeutic effects of ultra-short-wave diathermy (SWD) on COVID-19 pneumonia. The hypothesis is that SWD may minimise pneumonic inflammation and shorten the duration of the time to positive-to-negative conversion of COVID-19 nucleic acid test.
This is a single centre, 2-arm (1:1 ratio), evaluator blinded, parallel group design superiority randomised, controlled clinical trial.
The inclusion criteria were: (1) Age 18-65 years, (2) COVID-19 nucleic acid test is positive, (3) Lung CT showed multiple patchy ground glass shadows or other typical manifestations of both lungs. The exclusion criteria were: (1) Patients who need ICU management, (2) Positive tests for other pathogens such as Tuberculosis, Mycoplasma, (3) Patients with respiratory failure or requiring mechanical ventilation, (4) Patients with metal implants or pacemakers, (5) Those with shock (6) Those that have bleeding tendency or active bleeding in the lungs, (7) Patients with multiple organ failure who need ICU monitoring and treatment, (8) Cancer patients and those with severe underlying diseases, (9) Pregnant or lactating women, (10) Patients with severe cognitive impairment who cannot follow the instructions to complete the treatment, (11) Those without signed informed consent and (12) Those with other contraindications to short wave. This study will be conducted in Tongji Hospital, Caidian, Wuhan, People's Republic of China.
The experimental group will be given the nationally recommended standard medical treatment + ultra-short-wave diathermy treatment. Ultra-short-wave therapy treatment will be performed through application of ultra-short-wave therapy machine electrodes on the anterior and posterior parts of the trunk for 10 minutes, twice a day for 12 consecutive days. The comparator will be the control, not receiving ultra-short-wave therapy, and will be given only the nationally recommended standard medical treatment.
The primary outcome measures will be time to positive-to-negative conversion of COVID-19 nucleic acid test by pharyngeal swab, in days assessed at 7, 14 ,21 and 28 days. The secondary outcome measures include nucleic acid test rate and recovery from symptoms, Vital signs assessment, Computed Tomography, Complete blood count, serum analysis and SIRS scale scores. Blinded evaluation will be at baseline (the day of starting ultra-short-wave diathermy) and after 28 days following the interventions.
A Randomization plan will be generated online on www.randomization.com using permuted blocks method, by a statistician who will not be part of the study. Small blocks of various sizes will be used. Patients will be randomized (1:1) between the experimental and control groups BLINDING (MASKING): This will be an evaluator blinded study. Due to the nature of the intervention, blinding of patients and healthcare workers is not possible.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of 410 patients will be randomised in 1:1 ratio to two groups: experimental group (n=205) and control group (n=205).
Protocol version 1 was approved on 02/12/2020. Recruitment for this trial began on 02/18/2020 and will be ongoing till the required sample size is reached. The analysis deadline is August 2020.
This randomised controlled trial has been prospectively registered with the Chinese Clinical Trials ( ChiCTR2000029972 ) on 17 February 2020.
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol." The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).
评估超短波透热疗法（SWD）治疗 COVID-19 肺炎的疗效。假设 SWD 可以最大程度地减轻肺部炎症，并缩短 COVID-19 核酸检测由阳性转为阴性的时间。
这是一项单中心、2 臂（1:1 比例）、评估者盲法、平行组设计的优效性随机对照临床试验。
纳入标准为：（1）年龄 18-65 岁，（2）COVID-19 核酸检测阳性，（3）肺部 CT 显示多发性斑片状磨玻璃影或其他典型的双肺表现。排除标准为：（1）需要 ICU 管理的患者，（2）检测出其他病原体阳性，如结核分枝杆菌、支原体，（3）呼吸衰竭或需要机械通气的患者，（4）有金属植入物或起搏器的患者，（5）休克的患者，（6）有出血倾向或肺部活动性出血的患者，（7）需要 ICU 监测和治疗的多器官功能衰竭患者，（8）癌症患者和有严重基础疾病的患者，（9）孕妇或哺乳期妇女，（10）严重认知障碍无法按照指示完成治疗的患者，（11）未签署知情同意书的患者，（12）有其他短波禁忌证的患者。本研究将在中华人民共和国武汉市蔡甸区同济医院进行。
实验组将接受国家推荐的标准医疗+超短波透热治疗。超短波治疗将通过在胸部前后部位应用超短波治疗机电极进行治疗，每次 10 分钟，每天 2 次，连续 12 天。对照组为对照，不接受超短波治疗，仅接受国家推荐的标准医疗。
主要结局指标将是通过咽拭子检测 COVID-19 核酸检测由阳性转为阴性的时间，分别在第 7、14、21 和 28 天评估。次要结局指标包括核酸检测率和症状恢复情况、生命体征评估、计算机断层扫描、全血细胞计数、血清分析和 SIRS 评分。在基线（开始超短波透热治疗的那一天）和干预后 28 天进行盲法评估。
随机方案将由一名不参与研究的统计学家在 www.randomization.com 网站上在线生成，使用置换块方法。将使用各种大小的小块。患者将按 1:1 的比例随机分为实验组（n=205）和对照组（n=205）。
盲法（BLINDING）：这将是一项评估者盲法研究。由于干预的性质，不可能对患者和医护人员进行盲法。
随机分组数量（样本量）：总共将随机分组 410 例患者，按 1:1 比例分为两组：实验组（n=205）和对照组（n=205）。
方案版本 1 于 2020 年 12 月 2 日获得批准。本试验的招募工作于 2020 年 2 月 18 日开始，将持续到达到所需的样本量。分析截止日期为 2020 年 8 月。
这项随机对照试验已在中国临床试验（ChiCTR2000029972）上进行了前瞻性注册，于 2020 年 2 月 17 日注册。
完整方案作为附加文件附后，可从试验网站（附加文件 1）访问。为了加快传播本材料的速度，熟悉的格式已被删除；本信函是对完整方案关键要素的总结。该研究方案已按照标准方案项目：临床干预试验建议（SPIRIT）指南（附加文件 2）进行了报告。
