Spray vs EMLA Cream on Pain During Intra-articular Injection
Primary Purpose
Adhesive Capsulitis of the Shoulder
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Walter Ritter Ethyl Chloride Spray
Placebo Spray
Placebo Cream
EMLA Cream
Sponsored by
About this trial
This is an interventional treatment trial for Adhesive Capsulitis of the Shoulder
Eligibility Criteria
Inclusion Criteria:
- Who had a normative schedule of intra-articular injection of shoulder
Exclusion Criteria:
- those who refused to participate, those who were unable to understand a visual analog scale or a Likert scale, those with a history of an allergic reaction to vapocoolant spray or lidocaine, those with a history of cold intolerance (eg, Raynaud syndrome), those who took pain medications or had used topical anesthetics within the previous 24 hours, those with prior history of intra-articular injection of shoulder, those who exhibited an abnormal shoulder sensation on neurologic examination
Sites / Locations
- Soonchunhyang University Hospital, BucheonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Spray group
EMLA group
Placebo group
Arm Description
Using Walter Ritter Ethyl Chloride Spray and placebo cream
Using EMLA cream and placebo spray
Using placebo cream and placebo spray
Outcomes
Primary Outcome Measures
Visual analog scale for injection pain
The 100-mm VAS consisted of a 100-mm horizontal line labeled ''no pain'' at the left and ''worst pain imaginable'' at the right.
Secondary Outcome Measures
Five point Likert scale for participant's satisfaction
The five-point Likert scale (1, strongly agree; 2, agree; 3, undecided; 4, disagree; and 5, strongly disagree) is used to answer the question: ''Are you satisfied with the topical anesthetic methods used before performing the shoulder intra-articular injection?''
Five point Likert scale for preferences for future usage
The five-point Likert scale (1, strongly agree; 2, agree; 3, undecided; 4, disagree; and 5, strongly disagree) is used to answer the question: "Would you use the topical anesthetic methods applied today again if the shoulder intra-articular injection is repeated in the future?"
Full Information
NCT ID
NCT03484832
First Posted
March 26, 2018
Last Updated
April 4, 2019
Sponsor
Soonchunhyang University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03484832
Brief Title
Spray vs EMLA Cream on Pain During Intra-articular Injection
Official Title
Comparison of the Effects of Vapocoolant Spray and Topical Anesthetic Cream on Pain During Intra-articular Injection of Shoulder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 14, 2018 (Actual)
Primary Completion Date
March 19, 2020 (Anticipated)
Study Completion Date
May 19, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soonchunhyang University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
All participants are randomly allocated to the spray group, EMLA group and placebo group. In spray group, participants receive an application of placebo cream at the needle electrode insertion site 60 minutes before needle insertion, and a self adhering dressing is placed over the site. After 60 minutes, the dressing and cream are removed from the site, then the insertion site is sprayed from a distance of 30 cm for 5 seconds or until the skin was blanched, then intra-articular injection of shoulder is performed. Immediately after injection, participants are asked to fill out the visual analog scale for injectional pain, five point Likert scale for satisfaction about the topical anesthesia. In EMLA group, participants receive an EMLA cream and placebo spray. In placebo group, participants receive a placebo cream and placebo spray.
Detailed Description
All participants are randomly allocated to the spray group, EMLA group and placebo group.
In spray group, participants receive an application of placebo cream at the needle electrode insertion site 60 minutes before needle insertion, and a self adhering dressing is placed over the site. After 60 minutes, the dressing and cream are removed from the site, then the insertion site is sprayed using ethyl chloride spray (Walter Ritter GmbH and Co., Hamburg, Germany) from a distance of 30 cm for 5 seconds or until the skin was blanched, then intra-articular injection of shoulder is performed. Immediately after injection, participants are asked to fill out the visual analog scale for injectional pain, five point Likert scale for satisfaction about the topical anesthesia.
In EMLA group, participants receive an application of EMLA cream at the needle electrode insertion site 60 minutes before needle insertion, and a self adhering dressing is placed over the site. After 60 minutes, the dressing and cream are removed from the site, then the insertion site is sprayed using placebo spray (Evain Eau Minerale Naturelle, a pure water spray with hydrocarbon propellant), then intra-articular injection of shoulder is performed. Immediately after injection, participants are asked to fill out the same scales.
In placebo group, participants receive a placebo cream and placebo spray.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis of the Shoulder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Spray group
Arm Type
Experimental
Arm Description
Using Walter Ritter Ethyl Chloride Spray and placebo cream
Arm Title
EMLA group
Arm Type
Experimental
Arm Description
Using EMLA cream and placebo spray
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Using placebo cream and placebo spray
Intervention Type
Device
Intervention Name(s)
Walter Ritter Ethyl Chloride Spray
Intervention Description
Participants receive an application of EMLA or placebo cream at the needle electrode insertion site 60 minutes before needle insertion, and a self adhering dressing is placed over the site. After 60 minutes, the dressing and cream are removed from the site, then the insertion site is sprayed from a distance of 30 cm for 5 seconds or until the skin was blanched, then intra-articular injection of shoulder is performed.
Intervention Type
Other
Intervention Name(s)
Placebo Spray
Intervention Description
Participants receive an application of EMLA or placebo cream at the needle electrode insertion site 60 minutes before needle insertion, and a self adhering dressing is placed over the site. After 60 minutes, the dressing and cream are removed from the site, then the insertion site is sprayed using placebo spray (Evain Eau Minerale Naturelle, a pure water spray with hydrocarbon propellant), then intra-articular injection of shoulder is performed.
Intervention Type
Other
Intervention Name(s)
Placebo Cream
Intervention Description
Participants receive an application of placebo cream at the needle electrode insertion site 60 minutes before needle insertion, and a self adhering dressing is placed over the site. After 60 minutes, the dressing and cream are removed from the site, then the insertion site is sprayed using Walter Ritter Ethyl chloride spray or placebo spray, then intra-articular injection of shoulder is performed.
Intervention Type
Drug
Intervention Name(s)
EMLA Cream
Other Intervention Name(s)
EMLA 5% cream
Intervention Description
Participants receive an application of EMLA cream at the needle electrode insertion site 60 minutes before needle insertion, and a self adhering dressing is placed over the site. After 60 minutes, the dressing and cream are removed from the site, then the insertion site is sprayed using Walter Ritter Ethyl chloride spray or placebo spray, then intra-articular injection of shoulder is performed.
Primary Outcome Measure Information:
Title
Visual analog scale for injection pain
Description
The 100-mm VAS consisted of a 100-mm horizontal line labeled ''no pain'' at the left and ''worst pain imaginable'' at the right.
Time Frame
Within 5 minute
Secondary Outcome Measure Information:
Title
Five point Likert scale for participant's satisfaction
Description
The five-point Likert scale (1, strongly agree; 2, agree; 3, undecided; 4, disagree; and 5, strongly disagree) is used to answer the question: ''Are you satisfied with the topical anesthetic methods used before performing the shoulder intra-articular injection?''
Time Frame
Within 5 minute
Title
Five point Likert scale for preferences for future usage
Description
The five-point Likert scale (1, strongly agree; 2, agree; 3, undecided; 4, disagree; and 5, strongly disagree) is used to answer the question: "Would you use the topical anesthetic methods applied today again if the shoulder intra-articular injection is repeated in the future?"
Time Frame
Within 5 minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Who had a normative schedule of intra-articular injection of shoulder
Exclusion Criteria:
those who refused to participate, those who were unable to understand a visual analog scale or a Likert scale, those with a history of an allergic reaction to vapocoolant spray or lidocaine, those with a history of cold intolerance (eg, Raynaud syndrome), those who took pain medications or had used topical anesthetics within the previous 24 hours, those with prior history of intra-articular injection of shoulder, those who exhibited an abnormal shoulder sensation on neurologic examination
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SANGHYUN KIM
Phone
821023577324
Email
sanghyunkim71@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SANGHYUN KIM
Organizational Affiliation
Soonchunhyang University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soonchunhyang University Hospital, Bucheon
City
Bucheon
State/Province
Gyeonggido
ZIP/Postal Code
420767
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SANGHYUN KIM
Phone
821023577324
Email
sanghyunkim71@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32445850
Citation
Moon YE, Kim SH, Seok H, Lee SY. Comparison of the Effects of Vapocoolant Spray and Topical Anesthetic Cream on Pain During Intraarticular Injection of the Shoulder: A Randomized Double-Blind Controlled Trial. Arch Phys Med Rehabil. 2020 Oct;101(10):1689-1695. doi: 10.1016/j.apmr.2020.04.021. Epub 2020 May 20.
Results Reference
derived
Learn more about this trial
Spray vs EMLA Cream on Pain During Intra-articular Injection
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