The Effect of Needle Size on Pain Perception in Patients Treated With Botulinum Toxin A Injections
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- Northwestern University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Visual analog score (VAS) pain rating after each side is injected
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to compare the levels of pain resulting from injections of Botox® for wrinkles on the forehead and between the eyes using two different sized needles (32 gauge and 30 gauge needles).
Detailed Description
Subjects will be screened, assessed, and randomized to be injected with onabotulinum toxin A using a 30-gauge needle on one side of the face and injected using a 32-gauge needle on the other side during their first clinic visit. This study is a pilot study designed to determine feasibility of these procedures.
Investigators
Murad Alam
Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation
Northwestern University
Eligibility Criteria
Inclusion Criteria
- •In good health
- •Is a female
- •Is 25-70 years of age
- •Has moderate dynamic forehead/glabellar wrinkles
- •Has willingness and the ability to understand and provide informed consent and communicate with the study staff
Exclusion Criteria
- •Younger than 25 or older than 70 years of age
- •Pregnant or lactating
- •Has received the following treatments in the forehead or glabellar region:
- •botulinum toxin injections in the past 6 months
- •ablative laser procedure in the past 6 months
- •radiofrequency device treatment in the past 6 months
- •ultrasound device treatment in the past 6 months
- •medium to deep chemical peel in the past 6 months
- •temporary soft tissue augmentation material in the area to be treated in the past year
- •semi-permanent soft tissue augmentation material in the area to be treated in the past 2 years
Outcomes
Primary Outcomes
Visual analog score (VAS) pain rating after each side is injected
Time Frame: 1 hour on Treatment day
Subjects will rate pain using the visual analog score (VAS 1-10) after each side is injected using the 30 or 32 gauge needles. Lower values represents less pain; higher values represents more pain.