A Pilot Study of Needle Size and Pain Perception With Botulinum Toxin A Injections
Status: | Completed |
---|---|
Conditions: | Chronic Pain |
Therapuetic Areas: | Musculoskeletal |
Healthy: | No |
Age Range: | 25 - 70 |
Updated: | 5/5/2014 |
Start Date: | November 2013 |
End Date: | January 2014 |
Contact: | Emily Poon, PhD |
Email: | research.nuderm@northwestern.edu |
Phone: | 312-695-4761 |
The Effect of Needle Size on Pain Perception in Patients Treated With Botulinum Toxin A Injections
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).
Botox® for wrinkles on the forehead and between the eyes using two different sized needles
(32 gauge and 30 gauge needles).
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.
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.
Inclusion Criteria:
1. In good health
2. Is a female
3. Is 25-70 years of age
4. Has moderate dynamic forehead/glabellar wrinkles
5. Has willingness and the ability to understand and provide informed consent and
communicate with the study staff
Exclusion Criteria:
1. Younger than 25 or older than 70 years of age
2. Pregnant or lactating
3. Is a male
4. Has received the following treatments in the forehead or glabellar region:
1. botulinum toxin injections in the past 6 months
2. ablative laser procedure in the past 6 months
3. radiofrequency device treatment in the past 6 months
4. ultrasound device treatment in the past 6 months
5. medium to deep chemical peel in the past 6 months
6. temporary soft tissue augmentation material in the area to be treated in the
past year
7. semi-permanent soft tissue augmentation material in the area to be treated in
the past 2 years
8. permanent soft tissue augmentation material in the area to be treated
5. Has an active infection in the forehead or glabellar region (excluding mild acne)
6. Is allergic to cow's-milk protein
7. Is allergic to albumin
8. Taking aminoglycoside
9. Is currently using anticoagulation therapy
10. Has a history of bleeding disorders
11. Has a mental illness
12. Unable to understand the protocol or to give informed consent
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