A trial to evaluate the efficacy of carbon dioxide paste

Phase 2

Recruiting

• Conditions: Patients after neck dissection

• Registration Number: JPRN-jRCTs051210028
• Lead Sponsor: Hasegawa Takumi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1.Patients who are 20 years of age or older at informed consent
2.Patients with postoperative scarring pain after unilateral neck dissection
3.Patients from 6 months to 3 years after neck dissection
4.Patients with a VAS score of 1 or more but for neck pain
5.Patients who decide to participate in this clinical study by free will

Exclusion Criteria

1.Patients with drug sensitivity such as allergies
2.Patients with peripheral arterial disease and ischemia (Fontaine III -IV), Patients with ischemic cerebral artery disease
3.Patients with heart failure and severe ischemic heart disease
4.Female patients who are pregnant, lactating, seeking to become pregnant within the study period, or who are unable to accept contraception
5.Patients with severe respiratory disease with SpO2: 90% or less
6.Patients who have difficulty applying the paste, such as those with skin ulcers or skin diseases larger than 4cm x 4cm x 1cm
7.Patients who are deemed inappropriate by the investigators of this clinical study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline (Day 1: pre-application) in VAS values of neck pain at the end of study drug application (Day 15)

Secondary Outcome Measures

Name	Time	Method
Change from baseline (Day 1: pre-application) in VAS values of neck pain at the end of the clinical study (Day 29)<br>Change from baseline in grip strength at the end of study drug application (Day 15) and the clinical study (Day 29)<br>Change from baseline in VAS values for subjective symptoms (the feeling of strangulation, numbness, swelling, and warmth in neck and shoulder region) at the end of the study (Day 15) and the clinical study (Day 29) <br>Whether VAS (>30% improvement) improved from baseline (Day 1) at the end of study drug<br>Change from baseline in the arm elevation test at the end of study drug application (Day 15) and the clinical study (Day 29)<br>Change from baseline in shoulder range of motion (abduction and flexion) at the end of study drug application (Day 15) and the clinical study (Day 29)<br>Occurrence of skin disorders<br>Occurrence of serious side effects