Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-02-26 @ 5:13 PM
Study NCT ID:
NCT03914092
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2019-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intralesional Steroid Injection Versus Voice Therapy in Management of Vocal Nodules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014222', 'term': 'Triamcinolone Acetonide'}, {'id': 'D014221', 'term': 'Triamcinolone'}], 'ancestors': [{'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-28', 'studyFirstSubmitDate': '2019-04-06', 'studyFirstSubmitQcDate': '2019-04-11', 'lastUpdatePostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective measurements of severity of dysphonia', 'timeFrame': 'Before intervention', 'description': 'Measurements of Grade of Dysphonia, strain, leakiness, Breathiness and irregularity by auditory perceptual assessment using modified (GRBAS) scale. Grades ranging from 0 (normal) up to 3 ( severe)'}, {'measure': "Subjective measurements of patient's assessment of voice severity", 'timeFrame': 'Before intervention', 'description': 'Measurements of scores of Arabic Voice Handicap Index'}, {'measure': 'Objective measurements of vocal nodules size', 'timeFrame': 'before intervention', 'description': 'Measurements of base and rise of nodules using videostroboscopic examination'}, {'measure': 'Objective measurements of vocal pitch', 'timeFrame': 'Before intervention', 'description': 'Measurements of acoustic analysis: fundamental frequency (Hz)'}, {'measure': 'Objective measurements of vocal waveform frequency aperiodicity', 'timeFrame': 'Before intervention', 'description': 'Measurements of acoustic analysis: jitter (%)'}, {'measure': 'Objective measurements of vocal waveform amplitude aperiodicity', 'timeFrame': 'Before intervention', 'description': 'Measurements of acoustic analysis: shimmer (dB)'}, {'measure': 'Objective measurements of vocal waveform periodicity to aperiodicity ratio', 'timeFrame': 'Before intervention', 'description': 'Measurements of acoustic analysis : harmonic to noise ratio(dB)'}], 'secondaryOutcomes': [{'measure': 'Change in Subjective measurements of severity dysphonia', 'timeFrame': '1, 2 and 3 months after intervention', 'description': 'Measurements of change of Grade of Dysphonia, strain, leakiness, Breathiness and irregularity by auditory perceptual assessment using modified (GRBAS) scale. Grades ranging from 0 (normal) up to 3 ( severe)'}, {'measure': "Change in subjective measurements of patient's assessment of voice severity", 'timeFrame': '1, 2 and 3 months after intervention', 'description': 'Measurements of change in scores of Arabic Voice Handicap Index'}, {'measure': 'Change in objective measurements of vocal nodules size', 'timeFrame': '1, 2 and 3 months after intervention', 'description': 'Measurements of change in base and rise of nodules using videostroboscopic examination'}, {'measure': 'Change in objective measurements of vocal pitch', 'timeFrame': '1, 2 and 3 months after intervention', 'description': 'Measurements of change in acoustic analysis including fundamental frequency (Hz)'}, {'measure': 'Change in objective measurements of vocal waveform frequency aperiodicity', 'timeFrame': '1,2 and 3 months after intervention', 'description': 'Measurements of change in acoustic analysis : jitter (%)'}, {'measure': 'Change in objective measurements of vocal waveform amplitude aperiodicity', 'timeFrame': '1,2 and 3 months after intervention', 'description': 'Measurements of change in acoustic analysis : shimmer (dB)'}, {'measure': 'Change in objective measurements of vocal waveform periodicity to aperiodicity ratio', 'timeFrame': '1,2 and 3 after intervention', 'description': 'Change in measurements of acoustic analysis : harmonic to noise ratio (dB)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vocal Nodules in Adults']}, 'referencesModule': {'references': [{'pmid': '9691529', 'type': 'BACKGROUND', 'citation': 'Bassiouny S. Efficacy of the accent method of voice therapy. Folia Phoniatr Logop. 1998;50(3):146-64. doi: 10.1159/000021458.'}, {'pmid': '19779349', 'type': 'BACKGROUND', 'citation': 'Tateya I. Laryngeal steroid injection. Curr Opin Otolaryngol Head Neck Surg. 2009 Dec;17(6):424-6. doi: 10.1097/MOO.0b013e3283327d4c.'}, {'pmid': '20336925', 'type': 'BACKGROUND', 'citation': 'Campagnolo AM, Tsuji DH, Sennes LU, Imamura R, Saldiva PH. Histologic study of acute vocal fold wound healing after corticosteroid injection in a rabbit model. Ann Otol Rhinol Laryngol. 2010 Feb;119(2):133-9. doi: 10.1177/000348941011900211.'}, {'pmid': '22006779', 'type': 'BACKGROUND', 'citation': 'Lee SH, Yeo JO, Choi JI, Jin HJ, Kim JP, Woo SH, Jin SM. Local steroid injection via the cricothyroid membrane in patients with a vocal nodule. Arch Otolaryngol Head Neck Surg. 2011 Oct;137(10):1011-6. doi: 10.1001/archoto.2011.168.'}, {'pmid': '22074107', 'type': 'BACKGROUND', 'citation': 'Woo JH, Kim DY, Kim JW, Oh EA, Lee SW. Efficacy of percutaneous vocal fold injections for benign laryngeal lesions: Prospective multicenter study. Acta Otolaryngol. 2011 Dec;131(12):1326-32. doi: 10.3109/00016489.2011.620620.'}, {'pmid': '25944294', 'type': 'BACKGROUND', 'citation': 'Wang CT, Lai MS, Hsiao TY. Comprehensive Outcome Researches of Intralesional Steroid Injection on Benign Vocal Fold Lesions. J Voice. 2015 Sep;29(5):578-87. doi: 10.1016/j.jvoice.2014.11.002. Epub 2015 May 2.'}, {'pmid': '28334309', 'type': 'BACKGROUND', 'citation': 'Wang CT, Lai MS, Cheng PW. Long-term Surveillance Following Intralesional Steroid Injection for Benign Vocal Fold Lesions. JAMA Otolaryngol Head Neck Surg. 2017 Jun 1;143(6):589-594. doi: 10.1001/jamaoto.2016.4418.'}]}, 'descriptionModule': {'briefSummary': 'Vocal nodules represent 16 % of benign vocal fold lesions.They are caused by chronic voice abuse or misuse and often occur in children and adult females. The resultant dysphonia leads to personal, social and occupational problems.\n\nThe first line of treatment is voice rest and voice therapy. The Accent method is a holistic technique for behavior readjustment voice therapy which targets various voice parameters as loudness, pitch and timbre. However, voice rest and voice therapy are sometimes difficult to be carried out in patients with voice-related occupations. So, complete resolution may not be possible in all patients. When voice therapy is inefficient, resection is performed by laryngeal microsurgery under general anesthesia. However, the role of surgery is much restricted.', 'detailedDescription': 'An intralesional steroid injection to vocal nodules has come to the forefront as another treatment choice. Steroids decrease the synthesis and maturation of collagen, suppress fibroblast function, and inhibit the antibacterial phagocytic action of some defense cells and vasoactive substances release.These actions are considered to be functional for treating vocal nodules. Many studies, investigated steroid injection in benign lesions including nodules, reported that 93-100% of the nodules either disappeared or improved. The reported nodules recurrence rate after 2 years was 26.7- 31%.\n\nHowever, to our knowledge, no previous study has compared vocal nodule steroid injection with a group receiving voice therapy to accurately assess the clinical role of vocal fold steroid injection.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- 1- Female patients diagnosed with bilateral vocal fold soft edematous nodules with preserved stroboscopic waves , don't exceed base 2.5 mm and apex .5mm.\n\n2- age: 18-55 years. 3- Normal articulation, resonance and language ability. 4- Normal hearing.\n\nExclusion Criteria:\n\n* 1- Previous voice therapy or micro-phono-surgery. 2- Use of drugs (which may cause changes in laryngeal function, mucosa, or muscle activity).\n\n 3- History of allergies, lung disease, gastroesophageal reflux disease, or other concomitant vocal pathology (e.g., vocal polyp and vocal cyst).\n\n 4- Current psychiatric, neurological conditions."}, 'identificationModule': {'nctId': 'NCT03914092', 'briefTitle': 'Intralesional Steroid Injection Versus Voice Therapy in Management of Vocal Nodules', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Intralesional Steroid Injection Versus Accent Method of Voice Therapy in Management of Vocal Nodules: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'QWE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group', 'description': 'female patients with vocal fold nodules undergoing intralesional steroid injection', 'interventionNames': ['Drug: triamcinolone acetonide injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'female patients with vocal fold nodules undergoing Smith Accent voice therapy', 'interventionNames': ['Behavioral: Smith Accent method of voice therapy']}], 'interventions': [{'name': 'triamcinolone acetonide injection', 'type': 'DRUG', 'otherNames': ['kenacort'], 'description': ',1 mm percutaneous intralesional injection', 'armGroupLabels': ['study group']}, {'name': 'Smith Accent method of voice therapy', 'type': 'BEHAVIORAL', 'description': 'regular sessions of smith accent voice therapy (about 24 sessions, twice session / week) for 3 months', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Assiut university hospitals', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Eman S Hassan, MD', 'role': 'CONTACT', 'email': 'eshh2003@aun.edu.eg', 'phone': '00201004082014'}, {'name': 'Hanan A Mohamed, MD', 'role': 'CONTACT', 'email': 'hanan.abdelrashed2007@yahoo.com', 'phone': '00201007954155'}], 'overallOfficials': [{'name': 'Nada A Kamel, M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Nada Ali Kamel', 'investigatorAffiliation': 'Assiut University'}}}}