Clinical trial NCT03484832: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Adhesive Capsulitis of the Shoulder
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 63
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual analog scale for injection pain
timeFrame: Within 5 minute
Secondary outcomes:
measure: Five point Likert scale for participant's satisfaction
timeFrame: Within 5 minute
measure: Five point Likert scale for preferences for future usage
timeFrame: Within 5 minute
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Hospital, Bucheon
state: Gyeonggido
Study officials:
affiliation: Soonchunhyang University Hospital
name: SANGHYUN KIM
role: PRINCIPAL_INVESTIGATOR
References:
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.