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The Efficacy of Carbon Dioxide Paste in Alleviating Pain in Patients After Neck Dissection: Protocol for a Double-Blinded, Randomized Controlled Trial

Tadokoro, Yoshiaki Takeda, Daisuke Saito, Izumi Yatagai, Nanae Kakei, Yasumasa Akashi, Masaya Hasegawa, Takumi 神戸大学

2023.11.13

概要

Background: Head and neck cancers that cause severe aesthetic and functional disorders normally metastasize to the cervical lymph nodes. Patients with cervical lymph node metastasis are undergoing neck dissection. Shoulder complaints are common after neck dissection, with patients reporting symptoms such as pain, weakness, shoulder droop, and disability. However, no safe and effective treatment is available for this condition at present. We will conduct a double-blinded, randomized controlled trial to evaluate the efficacy of carbon dioxide (CO₂) paste in relieving pain in patients after neck dissection. Objective: This will be the first clinical study to compare the efficacy of CO₂ paste with placebo in relieving postoperative pain in patients who underwent neck dissection. Methods: We will perform this trial at the Kobe University Hospital in Japan. Patients will be randomized 1:1 into the CO₂ paste and control groups. Patients in the CO₂ paste group will have the CO₂ paste applied to the cervical surface skin for 10 minutes once per day for 14 consecutive days. The primary end point of the study is a change in the visual analog scale (VAS) scores of neck pain from baseline on day 1 (preapplication) to the end of drug application (day 15). Secondary end points include changes in the following parameters from baseline on day 1 to the end of drug application (day 15) or the study (day 29): neck pain VAS score (days 1-29), grip strength (days 1-15 and 1-29), VAS scores for subjective symptoms (the feeling of strangulation, numbness, swelling, and warmth in the neck and shoulder region) for days 1-15 and 1-29, whether the VAS score improved more than 30% (days 1-15), the arm abduction test (days 1-15 and 1-29), shoulder range of motion (abduction and flexion) for days 1-15 and 1-29, occurrence of skin disorders, and occurrence of serious side effects. Periodic monitoring will be conducted for participants during the trial. This study was approved by the certified review board of Kobe University. Results: The intervention commenced in May 2021 and will continue until March 2024. The collected data will provide information on the efficacy of the CO₂ paste treatment. The primary end point will be compared using the Wilcoxon test, with the 1-sided significance level set at 5%. Each evaluation item will be summarized. Secondary efficacy end points will be analyzed to provide additional insights into the primary analysis. Findings based on the treatment effects are expected to be submitted for publication in 2025. Conclusions: This trial will provide exploratory evidence of the efficacy and safety of CO₂ paste in relieving pain in patients after neck dissection. Trial Registration: Japan Registry of Clinical Trials (jRCT) identifier: jRCTs051210028; https://jrct.niph.go.jp/en-latest-detail/jRCTs051210028 International Registered Report Identifier (IRRID): DERR1-10.2196/50500

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Abbreviations

CO2: carbon dioxide

CRF: case report form

EDC: electronic data capture

jRCT: Japan Registry of Clinical Trials

QOL: quality of life

REDCap: Research Electronic Data Capture

VAS: visual analog scale

Edited by A Mavragani; submitted 04.07.23; peer-reviewed by D Takahashi, S Sakakibara; comments to author 13.10.23; revised

version received 19.10.23; accepted 20.10.23; published 13.11.23

Please cite as:

Tadokoro Y, Takeda D, Saito I, Yatagai N, Kakei Y, Akashi M, Hasegawa T

The Efficacy of Carbon Dioxide Paste in Alleviating Pain in Patients After Neck Dissection: Protocol for a Double-Blinded, Randomized

Controlled Trial

JMIR Res Protoc 2023;12:e50500

URL: https://www.researchprotocols.org/2023/1/e50500

doi: 10.2196/50500

PMID: 37955944

Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 13.11.2023. This is an open-access article

distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which

permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR

Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on

https://www.researchprotocols.org, as well as this copyright and license information must be included.

https://www.researchprotocols.org/2023/1/e50500

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The Efficacy of Carbon Dioxide Paste in Alleviating Pain in Patients After Neck Dissection: Protocol for a Double-Blinded, Randomized Controlled Trial

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The Efficacy of Carbon Dioxide Paste in Alleviating Pain in Patients After Neck Dissection: Protocol for a Double-Blinded, Randomized Controlled Trial

概要

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関連論文

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