Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-01-11 @ 2:58 PM
Study NCT ID:
NCT06760559
Status:
COMPLETED
Last Update Posted:
2025-01-22
First Post:
2024-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Pre-injection Local Anesthesia Affect Experienced Pain During Intra-articular Hip Injections.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'targetDuration': '2 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2022-01-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-19', 'studyFirstSubmitDate': '2024-12-31', 'studyFirstSubmitQcDate': '2024-12-31', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric rating scales (NRS) scores', 'timeFrame': 'Questionnaire was given before the injection for anticipated pain evaluation and additional influencing factors on pain perception prior to injection and right after the injection for actual experienced pain.', 'description': 'Numeric rating scales (NRS) scores were measured before and after an injection in both, study and control groups to determine the anticipated pain compared to experienced pain after Intra-articular hip injection with or without local anasthesia.'}], 'secondaryOutcomes': [{'measure': 'Beck Anxiety Inventory (BAI) and fear of injections', 'timeFrame': 'Questionnaire was given before the injection for anticipated pain evaluation,Beck Anxiety Inventory (BAI) and additional influencing factors on pain perception prior to injection.', 'description': 'Correlation of BAI scores and other injection-related factors including fear of pain, needle visualization, needle size, and prior injection experiences to pre-injection anticipated pain.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain', 'injection', 'intra-articular', 'expectation', 'compliance'], 'conditions': ['Pain', 'Injection', 'Prevention', 'Assessment']}, 'descriptionModule': {'briefSummary': 'Intra-articular hip injections are commonly used for diagnostic and therapeutic purposes but are often associated with patient anxiety and fear. The disparity between anticipated and experienced pain during these injections, as well as the role of pre-injection local anesthesia in pain modulation, remains unclear.\n\nThis study investigates the difference between anticipated and experienced pain during intra-articular hip injections. In addition, the study examines the impact of pre-injection local anesthesia in 60 prospectively recruited patients, some of whom received pre-injection local anesthesia while others did not. These study findings provide valuable insights into experienced pain during intra-articular hip injections, which can be applied to improve patient experiences and treatment compliance.', 'detailedDescription': '1. Identification of patients in the outpatient clinic and completion of the questionnaires will be carried out by the principal investigator and sub-investigators in the clinic.\n2. Data processing will be conducted by physicians holding an MD certification.\n3. The type of study is prospective.\n4. Data collection will be performed using the medical records of Tel Aviv Medical Center Hospital only, covering the years 2021 and 2022.\n5. Demographic data will be collected, including gender, year of birth, age, diagnosis, indication for injection, and previous treatments. Clinical data will include underlying diseases, side of injection, complications, indications, and follow-up time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing first-time intra-articular hip injection as indicated by an orthopedic surgeon either for diagnostic (e.g. lidocaine test, arthrography) and/or therapeutic (steroid injection for osteoarthritis) purposes.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing a first-time intra-articular hip injection as indicated by an orthopedic surgeon.\n* Indications for injection include:\n* Diagnostic purposes (e.g., lidocaine test, arthrography)\n* Therapeutic purposes (e.g., steroid injection for osteoarthritis)\n* Participants must be 18 years of age or older.\n* No previous hip joint injections.\n* Ability to fill in the survey questionnaire.\n\nExclusion Criteria:\n\n* Patients under 18 years of age.\n* Patients with a known history of hypersensitivity or allergy to the injectant material (e.g., local anesthetics, steroids).\n* Patients lacking the ability to sign informed consent or complete a survey questionnaire.\n* Patients with previous hip joint injections, due to the potential for recalling prior pain experienced.'}, 'identificationModule': {'nctId': 'NCT06760559', 'briefTitle': 'Does Pre-injection Local Anesthesia Affect Experienced Pain During Intra-articular Hip Injections.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'Pain Scores Following Intrarticular Injections', 'orgStudyIdInfo': {'id': 'TLV-0674-21'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pre-injection superficial local anesthesia prior to Intra-articular corticosteroid injection', 'interventionNames': ['Procedure: Intra-articular corticosteroid injection']}, {'label': 'Patients without pre-injection local anesthesia prior to Intra-articular corticosteroid injection', 'interventionNames': ['Procedure: Intra-articular corticosteroid injection']}], 'interventions': [{'name': 'Intra-articular corticosteroid injection', 'type': 'PROCEDURE', 'otherNames': ['Local anasthesia'], 'description': 'Intra-articular hip injections with and without local anastesia and questionnaire about pain and anxiety related to the procedure was administered before and after the injection to the study and control groups.', 'armGroupLabels': ['Patients without pre-injection local anesthesia prior to Intra-articular corticosteroid injection', 'Pre-injection superficial local anesthesia prior to Intra-articular corticosteroid injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Tel Aviv Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Ehud Rath, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tel Aviv Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to medical confidentiality'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}