Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT04641156
Status:
COMPLETED
Last Update Posted:
2022-02-01
First Post:
2020-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Physical Therapy Exercise Program and Low-Level Laser Therapy on the Treatment of Cervicogenic Somatosensory Tinnitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014012', 'term': 'Tinnitus'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-16', 'studyFirstSubmitDate': '2020-11-17', 'studyFirstSubmitQcDate': '2020-11-20', 'lastUpdatePostDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS', 'timeFrame': '8 weeks', 'description': 'Numerical estimates of tinnitus severity before and after treatment for both groups'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tinnitus, Subjective']}, 'descriptionModule': {'briefSummary': 'To determine the effectiveness of adding a physical therapy exercise program to low-level laser therapy on the treatment of chronic tinnitus treatment'}, 'eligibilityModule': {'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ranged from 45 to 55 years old both sex\n* Unilateral tinnitus\n* Stable tinnitus for at least 3 months\n* suffering from severe chronic non-fluctuating subjective cervicogenic somatic tinnitus (CST)\n\nExclusion Criteria:\n\n* tinnitus with clear ontological etiologies as perforation of the tympanic membrane\n* external otitis media\n* conductive hearing loss\n* patients with a traumatic cervical spine injury, tumors\n* Any history of exposure to ototoxic drugs/substances\n* psychotic disorders with auditory hallucination'}, 'identificationModule': {'nctId': 'NCT04641156', 'briefTitle': 'Effect of Physical Therapy Exercise Program and Low-Level Laser Therapy on the Treatment of Cervicogenic Somatosensory Tinnitus', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Adding Supervised Physical Therapy Exercise Program to Photobiomodulation Therapy in the Treatment of Cervicogenic Somatosensory Tinnitus: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '6688'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low level LASER Therapy', 'description': 'Subjects in this group received low-level laser therapy', 'interventionNames': ['Other: Exercise Therapy program added to laser therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise group', 'description': 'Subjects in this group received additional planned exercise therapy program', 'interventionNames': ['Other: Exercise Therapy program added to laser therapy']}], 'interventions': [{'name': 'Exercise Therapy program added to laser therapy', 'type': 'OTHER', 'description': 'a supervised physical therapy exercise program for the neck muscles in the form of manual mobilizations for sternocleidomastoid muscle and upper fibers of trapezius in addition to myofascial trigger point release', 'armGroupLabels': ['Exercise group', 'Low level LASER Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2011', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Marwa Eid', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of physical therapy for surgery', 'investigatorFullName': 'Marwa Eid', 'investigatorAffiliation': 'Cairo University'}}}}