A trial to evaluate the efficacy of carbon dioxide paste

JRCT ID: jRCTs051210028

Registered date:24/05/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients after neck dissection
• Date of first enrollment: 27/07/2021
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Assigned test drug is applied to the cervical surface skin once a day for 10 minutes each time for a total of 14 consecutive days.

Outcome(s)

• Primary Outcome: Change from baseline (Day 1: pre-application) in VAS values of neck pain at the end of study drug application (Day 15)

Secondary Outcome

Change from baseline (Day 1: pre-application) in VAS values of neck pain at the end of the clinical study (Day 29)
Change from baseline in grip strength at the end of study drug application (Day 15) and the clinical study (Day 29)
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)
Whether VAS (>30% improvement) improved from baseline (Day 1) at the end of study drug
Change from baseline in the arm elevation test at the end of study drug application (Day 15) and the clinical study (Day 29)
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)
Occurrence of skin disorders
Occurrence of serious side effects

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Hasegawa Takumi