A Pilot Study of Needle Size and Pain Perception With Botulinum Toxin A Injections

Pain Clinical Trial

Official title:

The Effect of Needle Size on Pain Perception in Patients Treated With Botulinum Toxin A Injections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01981174
• Other study ID #: STU84470
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: January 2014

Study information

• Verified date: December 2021
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• 30-gauge needle

• 32-gauge needle

Locations

Country	Name	City	State
United States	Northwestern University Department of Dermatology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog score (VAS) pain rating after each side is injected	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.	1 hour on Treatment day