Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 4, 2023
Date Accepted: Oct 20, 2023
The Efficacy of Carbon Dioxide Paste in Alleviating Pain in Patients After Neck Dissection: Protocol for a Double-Blinded, Randomized Controlled Trial
ABSTRACT
Background:
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.
Objective:
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.
Methods:
This is the first clinical study to compare the efficacy of CO2 paste in relieving pain in patients undergoing neck dissection. The trials will be performed 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 min once per day for 14 consecutive days. The primary endpoint of the study is a change in the visual analog scale (VAS) scores of neck pain from baseline on day 1 (pre-application) to the end of the study drug application (day 15). Secondary endpoints include the changes in the following parameters from baseline on day 1 to the end of drug application (day 15) and/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 > 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; the occurrence of skin disorders; and the occurrence of serious side effects. 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. 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. Clinical Trial: Japan Registry of Clinical Trials (jRCT) identifier: jRCTs051210028. Registered on May 24, 2021.
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