Spray vs EMLA Cream on Pain During Intra-articular Injection

• ClinicalTrials.gov Identifier: NCT03484832
• Recruitment Status: Unknown
• First Posted: April 2, 2018
• Last Update Posted: April 8, 2019
• Sponsor: Soonchunhyang University Hospital
• Information provided by (Responsible Party): SANGHYUN KIM, Soonchunhyang University Hospital

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.

Condition or disease	Intervention/treatment	Phase
Adhesive Capsulitis of the Shoulder	Device: Walter Ritter Ethyl Chloride Spray; Other: Placebo Spray; Other: Placebo Cream; Drug: EMLA Cream	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 63 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of the Effects of Vapocoolant Spray and Topical Anesthetic Cream on Pain During Intra-articular Injection of Shoulder
• Actual Study Start Date: March 14, 2018
• Estimated Primary Completion Date: March 19, 2020
• Estimated Study Completion Date: May 19, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Spray group; Using Walter Ritter Ethyl Chloride Spray and placebo cream	Device: Walter Ritter Ethyl Chloride Spray; 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.; Other: Placebo Cream; 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.
Experimental: EMLA group; Using EMLA cream and placebo spray	Other: Placebo Spray; 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.; Drug: EMLA Cream; 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.; Other Name: EMLA 5% cream
Placebo Comparator: Placebo group; Using placebo cream and placebo spray	Other: Placebo Spray; 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.; Other: Placebo Cream; 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.

Outcome Measures

Primary Outcome Measures :

1. Visual analog scale for injection pain [ Time Frame: Within 5 minute ]
   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 :

1. Five point Likert scale for participant's satisfaction [ Time Frame: Within 5 minute ]
   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?''
2. Five point Likert scale for preferences for future usage [ Time Frame: Within 5 minute ]
   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?"

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: SANGHYUN KIM; 821023577324; sanghyunkim71@gmail.com

Locations

Korea, Republic of

Soonchunhyang University Hospital, Bucheon; Recruiting

Bucheon, Gyeonggido, Korea, Republic of, 420767

Contact: SANGHYUN KIM 821023577324 sanghyunkim71@gmail.com

Sponsors and Collaborators

Soonchunhyang University Hospital

Investigators

• Principal Investigator: SANGHYUN KIM; Soonchunhyang University Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: SANGHYUN KIM, MD. PhD. Professor of Physical Medicine and Rehabilitation, Soonchunhyang University Hospital
• ClinicalTrials.gov Identifier: NCT03484832
• Other Study ID Numbers: EMLA SPRAY
• First Posted: April 2, 2018
• Last Update Posted: April 8, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Bursitis; Joint Diseases; Musculoskeletal Diseases; Lidocaine, Prilocaine Drug Combination; Ethyl Chloride; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anesthetics, Combined