Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT05581433
Status:
UNKNOWN
Last Update Posted:
2022-10-21
First Post:
2022-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vapocoolant Spray Application During Intraarticular Knee Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C000719205', 'term': 'Iatrophobia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-19', 'studyFirstSubmitDate': '2022-10-11', 'studyFirstSubmitQcDate': '2022-10-12', 'lastUpdatePostDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain during injection', 'timeFrame': '10 seconds', 'description': 'the level of pain felt when the needle is inserted'}], 'secondaryOutcomes': [{'measure': 'patient satisfaction level', 'timeFrame': '10 minutes', 'description': 'patient satisfaction level due to the application'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteo Arthritis Knee', 'Injection Site Discomfort', 'Injection Fear']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about the effects of vapocoolant spray applied during intraarticular knee injections on pain and anxiety compared to injections without any agent application in patients with knee osteoarthritis.\n\nThe main questions it aims to answer are: • Contrary to popular belief, does coolant spray application really reduce pain? • Does it have an advantage over patients with placebo or no spray at all? After intraarticular knee hyaluronic acid application, patients will be asked to indicate injection-related pain and anxiety levels on a 100mm visual analog scale. Researchers will compare the patient groups who were applied coolant spray, placebo spray and injection without any spray.', 'detailedDescription': 'Patients who underwent intra-knee hyaluronic acid injection due to knee degenerative diseases (osteoarthritis), meniscus and cartilage problems between October 2022 and December 2022 will be prospectively included in the study. Demographic characteristics of the patients (age, gender, body mass index), degree of knee degeneration, and past surgical procedures will be recorded.\n\nBefore intra-articular injection can be given, one group will be sprayed with a vapocoolant, and one group will receive a placebo spray, while another group will receive no analgesic treatment while injection. Which patient will be evaluated in which group will be decided by randomization on the website www.random.org.\n\n1 minute after the injection, the patients will be asked to indicate their pain level (1) and anxiety level (2) while inserting the needle on the 100mm Visual Analogue Scale (VAS). The same survey will be repeated after 10 minutes, and whether they are satisfied with the whole process will be measured with the same scale and the results will be recorded. The results will be compared between the groups, and the demographic characteristics of the patients, the level and types of disease, and the effects of vapocoolant spray application will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients with osteoarthritis of the knee undergoing a normal HA injection scheduled between October 2022 and December 2022.\n\nExclusion Criteria:\n\n* Prior history of injection of the knee joint\n* Inability to understand the Visual Analog Scale,\n* History of cold intolerance\n* Use of pain medications or topical anesthetics within the previous 24 hours\n* Abnormal sensation or signs of infection over the injection site.'}, 'identificationModule': {'nctId': 'NCT05581433', 'briefTitle': 'Vapocoolant Spray Application During Intraarticular Knee Injection', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Rumeli University'}, 'officialTitle': 'Vapocoolant Spray Application During Intraarticular Knee Injection: Myth or Reality? A Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'E-10840098-772.02-762'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'vapocoolan spray applied group before injection', 'description': 'Vapocoolant spray will be applied to patients in this group before intra-articular knee injection.', 'interventionNames': ['Other: Topical Cooling Spray']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebospray applied group before injection', 'description': 'Placebo spray will be applied to patients in this group before intra-articular knee injection.', 'interventionNames': ['Other: Saline spray as Placebo']}, {'type': 'NO_INTERVENTION', 'label': 'No administration group before injection', 'description': 'In this group, no pain reliever application will be made before the application.'}], 'interventions': [{'name': 'Topical Cooling Spray', 'type': 'OTHER', 'description': 'The process of cooling the area to be injected with a cooling spray before the application in order to reduce the pain.', 'armGroupLabels': ['vapocoolan spray applied group before injection']}, {'name': 'Saline spray as Placebo', 'type': 'OTHER', 'description': 'Application of saline spray without cooling effect to the area to be injected for placebo purposes', 'armGroupLabels': ['placebospray applied group before injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34040', 'city': 'Istanbul', 'state': 'Silivri', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Halil Narlı, MD', 'role': 'CONTACT', 'email': 'halil.narli@anadoluhastaneleri.com', 'phone': '05543749667'}], 'facility': 'Private Silivri Anadolu Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Çağdaş Pamuk, MD', 'role': 'CONTACT', 'email': 'cagdaspamuk@hotmail.com', 'phone': '+905058133336'}], 'overallOfficials': [{'name': 'Çağdaş Pamuk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul Rumeli University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Rumeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asisstant Professor', 'investigatorFullName': 'Cagdas PAMUK', 'investigatorAffiliation': 'Istanbul Rumeli University'}}}}