Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT04768205
Status:
UNKNOWN
Last Update Posted:
2021-07-29
First Post:
2021-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy of Kinesio Taping With Therapy in the Treatment of Globus Pharyngeus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079564', 'term': 'Globus Sensation'}], 'ancestors': [{'id': 'D003291', 'term': 'Conversion Disorder'}, {'id': 'D013001', 'term': 'Somatoform Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055052', 'term': 'Athletic Tape'}], 'ancestors': [{'id': 'D001458', 'term': 'Bandages'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D009989', 'term': 'Orthotic Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-08-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-28', 'studyFirstSubmitDate': '2021-02-20', 'studyFirstSubmitQcDate': '2021-02-20', 'lastUpdatePostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Subject demographics', 'timeFrame': 'Baseline', 'description': 'The median values of age and ratio of gender in all groups'}], 'primaryOutcomes': [{'measure': 'The outcomes of Glasgow Edinburg Throat Scale', 'timeFrame': 'Baseline', 'description': 'It was assessed by Turkish validated Glasgow Edinburg Throat Scale that a self questionnaire in globus pharyngeus patients. The minimum score is 0 and maximum score is 7 per question. The high scores were worst low scores were good.'}, {'measure': 'The outcomes of Glasgow Edinburg Throat Scale', 'timeFrame': '4 weeks', 'description': 'It was assessed by Turkish validated Glasgow Edinburg Throat Scale that a self questionnaire in globus pharyngeus patients. The minimum score is 0 and maximum score is 7 per question. The high scores were worst low scores were good.'}, {'measure': 'The outcomes of Glasgow Edinburg Throat Scale', 'timeFrame': '2 months', 'description': 'It was assessed by Turkish validated Glasgow Edinburg Throat Scale that a self questionnaire in globus pharyngeus patients. The minimum score is 0 and maximum score is 7 per question. The high scores were worst low scores were good.'}, {'measure': 'The outcomes of Beck depression inventory', 'timeFrame': 'Baseline', 'description': 'It was assessed by Turkish validated depression inventory that a questionnaire about psychosocial situations. The minimum score is 0 and maximum score is 3 per question. The high scores were worst low scores were good.'}, {'measure': 'The outcomes of Beck depression inventory', 'timeFrame': '4 weeks', 'description': 'It was assessed by Turkish validated Beck depression inventory that a questionnaire about psychosocial situations. The minimum score is 0 and maximum score is 3 per question. The high scores were worst low scores were good.'}, {'measure': 'The outcomes of Beck depression inventory', 'timeFrame': '2 months', 'description': 'It was assessed by Turkish validated Beck depression inventory that a questionnaire about psychosocial situations. The minimum score is 0 and maximum score is 3 per question. The high scores were worst low scores were good.'}, {'measure': 'The outcomes of Beck anxiety inventory', 'timeFrame': 'Baseline', 'description': 'It was assessed by Turkish validated Beck anxiety inventory that a questionnaire about psychosocial situations. The minimum score is 0 and maximum score is 3 per question. The high scores were worst low scores were good.'}, {'measure': 'The outcomes of Beck anxiety inventory', 'timeFrame': '4 weeks', 'description': 'It was assessed by Turkish validated Beck anxiety inventory that a questionnaire about psychosocial situations. The minimum score is 0 and maximum score is 3 per question. The high scores were worst low scores were good.'}, {'measure': 'The outcomes of Beck anxiety inventory', 'timeFrame': '2 months', 'description': 'It was assessed by Beck anxiety inventory that a questionnaire about psychosocial situations. The minimum score is 0 and maximum score is 3 per question. The high scores were worst low scores were good.'}, {'measure': 'The visual analog scale', 'timeFrame': 'Baseline', 'description': 'The globus sense was assessed by visual analog scale. The minimum score is 0 and maximum score is 100 on a line as 100 millimetres . The high scores were worst low scores were good.'}, {'measure': 'The visual analog scale', 'timeFrame': '4 weeks', 'description': 'The globus sense was assessed by visual analog scale. The minimum score is 0 and maximum score is 100 on a line as 100 millimetres. The high scores were worst low scores were good.'}, {'measure': 'The visual analog scale', 'timeFrame': '2 months', 'description': 'The globus sense was assessed by visual analog scale. The minimum score is 0 and maximum score is 100 on a line as 100 millimetres. The high scores were worst low scores were good.'}], 'secondaryOutcomes': [{'measure': 'Eating Assessment Tool', 'timeFrame': 'Baseline', 'description': 'The Turkish validated questionnaire consists of 10 questions that scores are from 0 to 40. Low score is better, higher score is worse.'}, {'measure': 'Eating Assessment Tool', 'timeFrame': '4 weeks', 'description': 'The Turkish validated questionnaire consists of 10 questions that scores are from 0 to 40. Low score is better, higher score is worse.'}, {'measure': 'Eating Assessment Tool', 'timeFrame': '2 months', 'description': 'The Turkish validated questionnaire consists of 10 questions that scores are from 0 to 40. Low score is better, higher score is worse.'}, {'measure': 'The outcomes of voice handicap index - 10', 'timeFrame': 'Baseline', 'description': 'It was assessed by Turkish validated voice handicap index - 10 that a self questionnaire in patients. The minimum score is 0 and maximum score is 4 per question. The high scores were worst low scores were good.'}, {'measure': 'The outcomes of voice handicap index - 10', 'timeFrame': '4 weeks', 'description': 'It was assessed by Turkish validated voice handicap index - 10 that a self questionnaire in patients. The minimum score is 0 and maximum score is 4 per question. The high scores were worst low scores were good.'}, {'measure': 'The outcomes of voice handicap index - 10', 'timeFrame': '2 months', 'description': 'It was assessed by Turkish validated voice handicap index - 10 that a self questionnaire in patients. The minimum score is 0 and maximum score is 4 per question. The high scores were worst low scores were good.'}, {'measure': 'The outcomes of reflux symptom index', 'timeFrame': 'Baseline', 'description': 'The laryngopharyngeal reflux was assessed by Turkish validated reflux symptom index - 10 that a self questionnaire in patients. The minimum score is 0 and maximum score is 5 per question. The high scores were worst low scores were good.'}, {'measure': 'The outcomes of reflux symptom index', 'timeFrame': '4 weeks', 'description': 'The laryngopharyngeal reflux was assessed by Turkish validated reflux symptom index - 10 that a self questionnaire in patients. The minimum score is 0 and maximum score is 5 per question. The high scores were worst low scores were good.'}, {'measure': 'The outcomes of reflux symptom index', 'timeFrame': '2 months', 'description': 'The laryngopharyngeal reflux was assessed by Turkish validated reflux symptom index - 10 that a self questionnaire in patients. The minimum score is 0 and maximum score is 5 per question. The high scores were worst low scores were good.'}, {'measure': 'Penetration and aspiration scale', 'timeFrame': 'Baseline', 'description': 'The scale consists of 8 levels for assessment of penetration and aspiration. The scores are from 0 to 8. Low score is better, higher score is worse.'}, {'measure': 'Yale pharyngeal residue severity rating scale', 'timeFrame': 'Baseline', 'description': 'The scale consists of 5 assessment units for pharyngeal residue. The scores are from 1 to 5. Low score is better, higher score is worse.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['kinesio taping', 'globus', 'globus pharyngeus', 'sensation', 'therapy'], 'conditions': ['Globus Pharyngeus']}, 'referencesModule': {'references': [{'pmid': '14725135', 'type': 'BACKGROUND', 'citation': 'Khalil HS, Bridger MW, Hilton-Pierce M, Vincent J. The use of speech therapy in the treatment of globus pharyngeus patients. A randomised controlled trial. Rev Laryngol Otol Rhinol (Bord). 2003;124(3):187-90.'}, {'pmid': '23088702', 'type': 'BACKGROUND', 'citation': 'Morris D, Jones D, Ryan H, Ryan CG. The clinical effects of Kinesio(R) Tex taping: A systematic review. Physiother Theory Pract. 2013 May;29(4):259-70. doi: 10.3109/09593985.2012.731675. Epub 2012 Oct 22.'}]}, 'descriptionModule': {'briefSummary': "Globus pharyngeus or sensation may be defined as a feeling of something a lump in the throat without dysphagia. Kinesio tex tape is a medical tap developed by Dr. Kase for therapeutic purposes and has been widely used in physical therapy applications in recent years. Although it is not a treatment with full consensus, the patient's complaints can be corrected with a small number of different therapy techniques or regulations on life.", 'detailedDescription': 'We conducted a therapy program with kinesio taping on patients who diagnosed with globus pharyngeus for 8 session with sham kinesio taping controlled group. This study aimed to assess of efficacy of the kinesio taping with therapy on patients patients who diagnosed with globus pharyngeus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed with globus pharyngeus\n* 18 -65 years\n* give a consent form\n\nExclusion Criteria:\n\n* patients with dysphagia or odynophagia\n* laryngeal organic pathologies\n* pharyngeal organic pathologies\n* epiglottic retroversion\n* malignancy\n* pregnancy\n* mental disorders\n* neurological disorders\n* major psychiatric disorders\n* give not a consent form'}, 'identificationModule': {'nctId': 'NCT04768205', 'briefTitle': 'The Efficacy of Kinesio Taping With Therapy in the Treatment of Globus Pharyngeus', 'organization': {'class': 'OTHER', 'fullName': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}, 'officialTitle': 'The Efficacy of Kinesio Taping With Therapy in the Treatment of Globus Pharyngeus: a Randomized Sham-controlled Trial', 'orgStudyIdInfo': {'id': '60'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Study group', 'description': 'The therapy and Kinesio tex gold tape that was affixed to stretched and neck localised were applied', 'interventionNames': ['Device: Kinesio tape']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sham control group', 'description': 'The therapy and Kinesio tex gold tape that was affixed to different neck localised as no-stretched were applied', 'interventionNames': ['Device: Kinesio tape']}], 'interventions': [{'name': 'Kinesio tape', 'type': 'DEVICE', 'description': 'The Kinesio tex tape is a medical tape that had been certified and patented.', 'armGroupLabels': ['Sham control group', 'Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34384', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Yavuz Atar, Asso Prof,MD', 'role': 'CONTACT', 'email': 'yavuzatar@gmail.com', 'phone': '+905052123297'}, {'name': 'Sevgi Atar, MD', 'role': 'CONTACT', 'email': 'sevgiatar@gmail.com', 'phone': '+905052123296'}, {'name': 'Hasan Sami Bircan, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yavuz Uyar, Prof., MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Prof Dr Cemil Tascioglu City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Yavuz Atar, Asso Prof,MD', 'role': 'CONTACT', 'email': 'yavuzatar@gmail.com', 'phone': '+905052123297'}, {'name': 'Sevgi Atar, MD', 'role': 'CONTACT', 'email': 'sevgiatar@gmail.com', 'phone': '+905052123296'}], 'overallOfficials': [{'name': 'Yavuz Atar, Asso Prof,MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Health Sciences, ENT Clinic, Prof Dr Cemil Tascioglu City Hospital'}, {'name': 'Sevgi Atar, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Health Sciences, PMR Clinic, Prof Dr Cemil Tascioglu City Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, M.D.', 'investigatorFullName': 'Yavuz Atar', 'investigatorAffiliation': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}}}}