Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
Study NCT ID:
NCT03484832
Status:
UNKNOWN
Last Update Posted:
2019-04-08
First Post:
2018-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Spray vs EMLA Cream on Pain During Intra-articular Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002062', 'term': 'Bursitis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077442', 'term': 'Lidocaine, Prilocaine Drug Combination'}], 'ancestors': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011318', 'term': 'Prilocaine'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 63}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2020-05-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-04', 'studyFirstSubmitDate': '2018-03-26', 'studyFirstSubmitQcDate': '2018-03-26', 'lastUpdatePostDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analog scale for injection pain', 'timeFrame': 'Within 5 minute', '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."}], 'secondaryOutcomes': [{'measure': "Five point Likert scale for participant's satisfaction", 'timeFrame': 'Within 5 minute', '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?''"}, {'measure': 'Five point Likert scale for preferences for future usage', 'timeFrame': 'Within 5 minute', '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?"'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adhesive Capsulitis of the Shoulder']}, 'referencesModule': {'references': [{'pmid': '32445850', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'All participants are randomly allocated to the spray group, EMLA group and placebo group.\n\nIn 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.\n\nIn 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.\n\nIn placebo group, participants receive a placebo cream and placebo spray.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Who had a normative schedule of intra-articular injection of shoulder\n\nExclusion Criteria:\n\n* 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'}, 'identificationModule': {'nctId': 'NCT03484832', 'briefTitle': 'Spray vs EMLA Cream on Pain During Intra-articular Injection', 'organization': {'class': 'OTHER', 'fullName': 'Soonchunhyang University Hospital'}, 'officialTitle': 'Comparison of the Effects of Vapocoolant Spray and Topical Anesthetic Cream on Pain During Intra-articular Injection of Shoulder', 'orgStudyIdInfo': {'id': 'EMLA SPRAY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spray group', 'description': 'Using Walter Ritter Ethyl Chloride Spray and placebo cream', 'interventionNames': ['Device: Walter Ritter Ethyl Chloride Spray', 'Other: Placebo Cream']}, {'type': 'EXPERIMENTAL', 'label': 'EMLA group', 'description': 'Using EMLA cream and placebo spray', 'interventionNames': ['Other: Placebo Spray', 'Drug: EMLA Cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Using placebo cream and placebo spray', 'interventionNames': ['Other: Placebo Spray', 'Other: Placebo Cream']}], 'interventions': [{'name': 'Walter Ritter Ethyl Chloride Spray', 'type': 'DEVICE', '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.', 'armGroupLabels': ['Spray group']}, {'name': 'Placebo Spray', 'type': 'OTHER', '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.', 'armGroupLabels': ['EMLA group', 'Placebo group']}, {'name': 'Placebo Cream', 'type': 'OTHER', '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.', 'armGroupLabels': ['Placebo group', 'Spray group']}, {'name': 'EMLA Cream', 'type': 'DRUG', 'otherNames': ['EMLA 5% cream'], '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.', 'armGroupLabels': ['EMLA group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '420767', 'city': 'Bucheon-si', 'state': 'Gyeonggido', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'SANGHYUN KIM', 'role': 'CONTACT', 'email': 'sanghyunkim71@gmail.com', 'phone': '821023577324'}], 'facility': 'Soonchunhyang University Hospital, Bucheon', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}], 'centralContacts': [{'name': 'SANGHYUN KIM', 'role': 'CONTACT', 'email': 'sanghyunkim71@gmail.com', 'phone': '821023577324'}], 'overallOfficials': [{'name': 'SANGHYUN KIM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soonchunhyang University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soonchunhyang University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD. PhD. Professor of Physical Medicine and Rehabilitation', 'investigatorFullName': 'SANGHYUN KIM', 'investigatorAffiliation': 'Soonchunhyang University Hospital'}}}}