Spray vs EMLA Cream on Pain During Intra-articular Injection

NCT03484832 | Unknown Phase 4

• 1 other identifier: EMLA SPRAY
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Adhesive Capsulitis of the Shoulder

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 5 minute

Secondary Outcomes (2)

• Five point Likert scale for participant's satisfaction

  Within 5 minute

• Five point Likert scale for preferences for future usage

  Within 5 minute

Study Arms (3)

Spray group

EXPERIMENTAL

Using Walter Ritter Ethyl Chloride Spray and placebo cream

Device: Walter Ritter Ethyl Chloride Spray; Other: Placebo Cream

EMLA group

EXPERIMENTAL

Using EMLA cream and placebo spray

Other: Placebo Spray; Drug: EMLA Cream

Placebo group

PLACEBO COMPARATOR

Using placebo cream and placebo spray

Other: Placebo Spray; Other: Placebo Cream

Interventions

Walter Ritter Ethyl Chloride Spray DEVICE

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.

Spray group

Placebo Spray OTHER

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.

EMLA group; Placebo group

Placebo Cream OTHER

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.

Placebo group; Spray group

EMLA Cream DRUG

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.

Also known as: EMLA 5% cream

EMLA group

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Who had a normative schedule of intra-articular injection of shoulder

You may not qualify if:

• 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

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead

Study Sites (1)

Soonchunhyang University Hospital, Bucheon

Bucheon-si, Gyeonggido, 420767, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 32445850 DERIVED

MeSH Terms

Conditions

Bursitis

Interventions

Lidocaine, Prilocaine Drug Combination

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• SANGHYUN KIM

  Soonchunhyang University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SANGHYUN KIM

CONTACT

821023577324; sanghyunkim71@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PhD. Professor of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 2, 2018
• Study Start: March 14, 2018
• Primary Completion: March 19, 2020
• Study Completion: May 19, 2020
• Last Updated: April 8, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)