Patients after neck dissection
Conditions
Interventions
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.
Sponsors
Hasegawa Takumi
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline (Day 1: pre-application) in VAS values of neck pain at the end of study drug application (Day 15) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactTakumi Hasegawa
Kobe University Hospital
Outcome results
None listed