ElectrodiagnosisPhase 4NCT01606046
Comparison of the Effects of Vapocoolant Spray and EMLA Cream on Pain During Needle Electromyography
A Phase 4 study testing vapocoolant spray and topical anesthetic cream in people with Electrodiagnosis, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the effects of vapocoolant spray and topical lidocaine 2.5% + prilocaine 2.5% cream (EMLA) on reducing pain during needle electromyography. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Electrodiagnosis
- What is being tested?
- vapocoolant spray and topical anesthetic cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2011to Aug 2011
- Phase
- Phase 4
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who had a normal schedule of needle EMGs in the lower extremity.
Who cannot join
- those who refused to participate in the experiment
- those who were unable to understand a VAS and Likert scale
- those with a history of allergic reaction to vapocoolant spray or lidocaine
- those with a history of cold intolerance (Raynaud's syndrome, etc.)
- those who took oral pain medications or used topical anesthetics within 24 hours of the experiment
- those who exhibited abnormal lower extremity sensation during the physical examination or who showed pain on gastrocnemius
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Soonc chun hyang university hospital Bucheon
Bucheon-si, Gyeonngi-do, 420-767
About this study
Official title: Comparison of the Effects of Vapocoolant Spray and Topical Anesthetic Cream on Pain During Needle Electromyography: a Randomized Controlled Clinical Trial
The purpose of this study is to compare the effects of vapocoolant spray and topical lidocaine 2.5% + prilocaine 2.5% cream (EMLA) on reducing pain during needle electromyography.
Read the detailed description
The study was conducted on patients with patients that underwent needle EMGs in the lower extremity between July and August 2011 at the university hospital. The patients were divided into a total of three groups by random assignment: a control group that did not receive pretreatment, a group that received ethyl chloride vapocoolant spray and a group that received topical anesthetic cream (EMLA cream®).The patients with spray group, they were sprayed with ethyl chloride vapocoolant spray for 5 seconds from a distance of 30 cm just before the needle EMG, and patients with EMLA cream, they received an application of topical anesthetic cream on the needle electrode insertion site 60 minutes before the needle EMG. The 37-mm monopolar needle electrode was vertically inserted into the medial head of the gastrocnemius muscle in all patients.
To assess the degree of pain for each group, patients were asked to indicate their level of pain on a 100 mm VAS (0, no pain; 100, worst intolerable pain) after the needle EMG in the gastrocnemius muscle.
In both experimental groups, a 5-point Likert scale was used to evaluate patient satisfaction with the pain reduction method used and their willingness to use the same analgesic method in another EMG.
- Conditions
- Electrodiagnosis
- Being tested
- vapocoolant spray, topical anesthetic cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vapocoolant sprayDevice
Also called Ethyl chloride spray
spray for 5 seconds from a distance of 30 cm just before the needle EMG
topical anesthetic creamDrug
Also called EMLA® (Eutectic Mixture of Local Anesthetics)
application of EMLA cream on the needle electrode insertion site 60 minutes before the needle EMG
| Study group | Role | What they receive |
|---|---|---|
| vapocoolant spray | Active comparator | Not described Receives: Device: vapocoolant spray |
| topical anesthetic agent | Active comparator | Not described Receives: Drug: topical anesthetic cream |
| Control | No intervention | no interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale, 5 point Likert scale
Measured: Immediately after the complete of needle electromyography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startJul 2011
- Primary completionJul 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElectrodiagnosisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Eun Moon, The Catholic University of Korea
- Investigators
- SangHyun Kim, Professor, Principal investigator, Department of rehabilitation, Soon chun hyang university hospital Bucheon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606046
- Sponsor's protocol ID
- momo0910
- Status last verified
- May 2012
- First submitted
- 23 May 2012
- Last updated
- 21 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Vapocoolant Spray and Topical Anesthetic Cream on Pain During Needle Electromyography: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01606046
- Acronym / sponsor ID
- momo0910
- Conditions
- Electrodiagnosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 25 May 2012 (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 effects of vapocoolant spray and topical lidocaine 2.5% + prilocaine 2.5% cream (EMLA) on reducing pain during needle electromyography.
Detailed description
The study was conducted on patients with patients that underwent needle EMGs in the lower extremity between July and August 2011 at the university hospital. The patients were divided into a total of three groups by random assignment: a control group that did not receive pretreatment, a group that received ethyl chloride vapocoolant spray and a group that received topical anesthetic cream (EMLA cream®).The patients with spray group, they were sprayed with ethyl chloride vapocoolant spray for 5 seconds from a distance of 30 cm just before the needle EMG, and patients with EMLA cream, they received an application of topical anesthetic cream on the needle electrode insertion site 60 minutes before the needle EMG. The 37-mm monopolar needle electrode was vertically inserted into the medial head of the gastrocnemius muscle in all patients.
To assess the degree of pain for each group, patients were asked to indicate their level of pain on a 100 mm VAS (0, no pain; 100, worst intolerable pain) after the needle EMG in the gastrocnemius muscle.
In both experimental groups, a 5-point Likert scale was used to evaluate patient satisfaction with the pain reduction method used and their willingness to use the same analgesic method in another EMG.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| vapocoolant spray | Active comparator | Device: vapocoolant spray |
| topical anesthetic agent | Active comparator | Drug: topical anesthetic cream |
| Control | No intervention | –no interventions |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who had a normal schedule of needle EMGs in the lower extremity.
Key exclusion criteria (6 listed)
- those who refused to participate in the experiment
- those who were unable to understand a VAS and Likert scale
- those with a history of allergic reaction to vapocoolant spray or lidocaine
- those with a history of cold intolerance (Raynaud's syndrome, etc.)
- those who took oral pain medications or used topical anesthetics within 24 hours of the experiment
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 |
|---|---|---|
| vapocoolant sprayAlso: Ethyl chloride sprayspray for 5 seconds from a distance of 30 cm just before the needle EMG | Device | vapocoolant spray |
| topical anesthetic creamAlso: EMLA® (Eutectic Mixture of Local Anesthetics)application of EMLA cream on the needle electrode insertion site 60 minutes before the needle EMG | Drug | topical anesthetic agent |
Primary outcome
visual analogue scale, 5 point Likert scale
Time frame: Immediately after the complete of needle electromyography
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 21 Jun 2012.
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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.
SangHyun Kim, Professor principal investigator
Department of rehabilitation, Soon chun hyang university hospital Bucheon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing vapocoolant spray and topical anesthetic cream in people with Electrodiagnosis, run by The Catholic University of Korea at 1 site in South Korea.
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 1 inclusion and 6 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 21 Jun 2012. 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 analogue scale, 5 point Likert scale (time frame: Immediately after the complete of needle electromyography). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2012.