PainNCT01981174
A Pilot Study of Needle Size and Pain Perception With Botulinum Toxin A Injections
A study testing 30-gauge needle and 32-gauge needle in people with Pain, run by Northwestern University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 25 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- 30-gauge needle and 32-gauge needle
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Younger than 25 or older than 70 years of age
- Pregnant or lactating
- Is a male
- 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
Show all 20Show fewer
- 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
- permanent soft tissue augmentation material in the area to be treated
- Has an active infection in the forehead or glabellar region (excluding mild acne)
- Is allergic to cow's-milk protein
- Is allergic to albumin
- Taking aminoglycoside
- Is currently using anticoagulation therapy
- Has a history of bleeding disorders
- Has a mental illness
- Unable to understand the protocol or to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: 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).
Read the 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.
- Conditions
- Pain
- Being tested
- 30-gauge needle, 32-gauge needle
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30-gauge needleProcedure or surgery
32-gauge needleProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 30-gauge needle | Active comparator | 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. All needles would be luer lock, ½ inch length, and attached to separate 1cc syringes. Injection depth would be 1-2mm, dermal, and the angle of incidence would be perpendicular. Receives: Procedure: 30-gauge needle |
| 32-gauge needle | Active comparator | 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. All needles would be luer lock, ½ inch length, and attached to separate 1cc syringes. Injection depth would be 1-2mm, dermal, and the angle of incidence would be perpendicular. Receives: Procedure: 32-gauge needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour on Treatment day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981174
- Sponsor's protocol ID
- STU84470
- Status last verified
- Dec 2021
- First submitted
- 5 Nov 2013
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alam M, Geisler A, Sadhwani D, Goyal A, Poon E, Nodzenski M, Schaeffer MR, Tung R, Minkis K. Effect of Needle Size on Pain Perception in Patients Treated With Botulinum Toxin Type A Injections: A Randomized Clinical Trial. JAMA Dermatol. 2015 Nov;151(11):1194-9. doi: 10.1001/jamadermatol.2015.2232.
PubMed 26352252
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Needle Size on Pain Perception in Patients Treated With Botulinum Toxin A Injections
- ClinicalTrials.gov ID
- NCT01981174
- Acronym / sponsor ID
- STU84470
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 11 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30-gauge needle | Active comparator | Procedure: 30-gauge needleSubjects 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. All needles would be luer lock, ½ inch length, and attached to separate 1cc syringes. Injection depth would be 1-2mm, dermal, and the angle of incidence would be perpendicular. |
| 32-gauge needle | Active comparator | Procedure: 32-gauge needleSubjects 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. All needles would be luer lock, ½ inch length, and attached to separate 1cc syringes. Injection depth would be 1-2mm, dermal, and the angle of incidence would be perpendicular. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- Younger than 25 or older than 70 years of age
- Pregnant or lactating
- Is a male
- Has received the following treatments in the forehead or glabellar region:
- Has an active infection in the forehead or glabellar region (excluding mild acne)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 30-gauge needle | Procedure or surgery | 30-gauge needle |
| 32-gauge needle | Procedure or surgery | 32-gauge needle |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Derived from this study: PubMed 26352252Alam M, Geisler A, Sadhwani D, Goyal A, Poon E, Nodzenski M, Schaeffer MR, Tung R, Minkis K. Effect of Needle Size on Pain Perception in Patients Treated With Botulinum Toxin Type A Injections: A Randomized Clinical Trial. JAMA Dermatol. 2015 Nov;151(11):1194-9. doi: 10.1001/jamadermatol.2015.2232.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murad Alam, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 30-gauge needle and 32-gauge needle in people with Pain, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog score (VAS) pain rating after each side is injected (time frame: 1 hour on Treatment day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01981174, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021; AzTrials last refreshed its copy on 6 Nov 2026.