Ultra–short-wave diathermy shortens the course of moderate and severe COVID-19: a randomized trial

  1. Liangjiang Huang
  2. Qian Li
  3. Shah Zulfiqar Ali Sayed
  4. Nasb Mohammad
  5. Bin Chen
  6. MPhil Ali Iftikhar
  7. Lingfeng Xie
  8. Jifa Hu
  9. Hong Chen

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Abstract

Question

Is ultra-short-wave diathermy (USWD) safe and effective in coronavirus disease 2019 (COVID-19) ?

Design

Single-centre, evaluator-blinded, two-arm, parallel design, randomized controlled clinical trial.

Participants

Moderate and severe COVID-19 patients with acute respiratory syndrome.

Intervention

USWD for 10 minutes twice daily for 12 consecutive days along with standard medical treatment (USWD group, n = 25), versus standard medical treatment alone (control group, n = 25).

Outcome measures

The primary outcomes were the duration of recovery and negative conversion rate of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on days 7, 14, 21, and 28. Secondary outcomes included clinical status (seven-category ordinal and systemic inflammatory response syndrome (SIRS) scores), computed tomography (CT), routine blood tests, and adverse events.

Results

Time to clinical recovery (USWD 36.84±9.93 vs. control 43.56±12.15, P = 0.037) was significantly shortened with a between-group difference of 6.72 days. Clinical status was improved with significant between-group differences on day 28 (SIRS, P = 0.011; seven-category scale, P = 0.003). The rate of RNA negative conversion at days 7 (P = 0.066), 14 (P = 0.239), 21 (P = 0.269), and 28 (P = 0.490) was statistically insignificant. Moreover, insignificant differences were observed in the artificial intelligence-assisted CT analysis. No treatment-associated adverse events or worsening of pulmonary fibrosis were observed.

Conclusion

USWD, as adjunctive therapy, shortened the recovery course and improved clinical status of patients with COVID-19 without aggravating pulmonary fibrosis. the findings are limited due to the small sample size and early termination.

Registration

ChiCTR2000029972

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  1. Version published to 10.1101/2021.01.28.21250163v2 on medRxiv
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    SciScore for 10.1101/2021.01.28.21250163: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementIRB: , evaluator-blinded, 2-arm (1:1 ratio) parallel design superiority randomized controlled trial was approved by the ethics committee of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China (certificate of approval number TJ-C20200127) and prospectively registered on February 17, 2020, with the Chinese Clinical Trials Registry (Identifier: ChiCTR2000029972).
    Consent: Before randomization, written and verbal informed consent was taken from every patient and an informative essay that clearly shows the risks and the supposed benefits accompanying the participation was provided to each patient.
    Randomization, evaluator-blinded, 2-arm (1:1 ratio) parallel design superiority randomized controlled trial was approved by the ethics committee of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China (certificate of approval number TJ-C20200127) and prospectively registered on February 17, 2020, with the Chinese Clinical Trials Registry (Identifier: ChiCTR2000029972).
    BlindingThis was an assessor-blinded controlled study, due to the nature of the interventions, the study could not be therapist or patient blinded; however, a well-trained health care team consisting of two evaluators, two statisticians, and two data collectors were blinded to the groups/treatment allocation.
    Power Analysis17 We estimated that with an 80% power, 5% two-sided type I error rate, and an effect size of 0.72, the enrolment of 62 participants would be enough to detect a statistically significant between-group difference of 6.6 days in the length of recovery from symptom.
    Sex as a biological variableThe exclusion criteria were (1) Positive tests for other pathogens such as Tuberculosis, Mycoplasma, (2) People with metal implants or pacemakers, (3) Patients with respiratory failure or requiring mechanical ventilation, (4) Patients with multiple organ failure who need ICU monitoring and treatment, (5) Those having a bleeding tendency or active bleeding in the lungs, (6) Those with shock, (7) Cancer patients and those with severe underlying diseases, (8) Patients with severe cognitive impairment,(9) Pregnant or lactating women, (10) Those without signed informed consent, (11) Those with other contraindications to short wave diathermy.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    All the statistical analyses were carried out using SPSS (Statistical Package for social sciences, version 25.0) and Graphpad Prism 8.
    SPSS
    suggested: (SPSS, RRID:SCR_002865)
    Graphpad Prism
    suggested: (GraphPad Prism, RRID:SCR_002798)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  3. Version published to 10.1101/2021.01.28.21250163v1 on medRxiv