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https://hdl.handle.net/20.500.14094/0100485288
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2024-06-12
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0100485288 (fulltext)
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メタデータID
0100485288
アクセス権
open access
出版タイプ
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タイトル
The Efficacy of Carbon Dioxide Paste in Alleviating Pain in Patients After Neck Dissection: Protocol for a Double-Blinded, Randomized Controlled Trial
著者
Tadokoro, Yoshiaki ; Takeda, Daisuke ; Saito, Izumi ; Yatagai, Nanae ; Kakei, Yasumasa ; Akashi, Masaya ; Hasegawa, Takumi
著者名
Tadokoro, Yoshiaki
著者ID
A2567
研究者ID
1000080755637
KUID
https://kuid-rm-web.ofc.kobe-u.ac.jp/search/detail?systemId=f59f62b200a1f47c520e17560c007669
著者名
Takeda, Daisuke
武田, 大介
タケダ, ダイスケ
所属機関名
医学部附属病院
著者名
Saito, Izumi
著者名
Yatagai, Nanae
著者ID
A2217
研究者ID
1000070772896
ORCID
0000-0002-5997-514X
KUID
https://kuid-rm-web.ofc.kobe-u.ac.jp/search/detail?systemId=3e2a39a5f4448ccc520e17560c007669
著者名
Kakei, Yasumasa
筧, 康正
カケイ, ヤスマサ
所属機関名
医学部附属病院
著者ID
A1492
研究者ID
1000040597168
KUID
https://kuid-rm-web.ofc.kobe-u.ac.jp/search/detail?systemId=b7649a2950dc725a520e17560c007669
著者名
Akashi, Masaya
明石, 昌也
アカシ, マサヤ
所属機関名
医学研究科
著者ID
A1489
研究者ID
1000050546497
KUID
https://kuid-rm-web.ofc.kobe-u.ac.jp/search/detail?systemId=322ffbb7f3848e30520e17560c007669
著者名
Hasegawa, Takumi
長谷川, 巧実
ハセガワ, タクミ
所属機関名
医学研究科
収録物名
JMIR Research Protocols
巻(号)
12
ページ
e50500
出版者
JMIR Publications
刊行日
2023-11-13
公開日
2023-11-21
抄録
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
キーワード
carbon dioxide
double-blind
neck dissection
pain
paste
postoperative
randomized controlled trial
surgery
surgical
カテゴリ
医学研究科
医学部附属病院
学術雑誌論文
権利
©Yoshiaki Tadokoro, Daisuke Takeda, Izumi Saito, Nanae Yatagai, Yasumasa Kakei, Masaya Akashi, Takumi Hasegawa.
This is an open-access article distributed under the terms of the Creative Commons Attribution License, 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.
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資源タイプ
journal article
言語
English (英語)
eISSN
1929-0748
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関連情報
DOI
https://doi.org/10.2196/50500
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