Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-16 @ 6:56 AM
Study NCT ID:
NCT06433895
Status:
COMPLETED
Last Update Posted:
2025-07-03
First Post:
2024-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Manual Therapy in the Treatment of Somatic 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2024-05-23', 'studyFirstSubmitQcDate': '2024-05-23', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale for Tinnitus (VAS-tinnitus)', 'timeFrame': 'baseline- 6 week', 'description': 'The severity of tinnitus will be graded using a 10 cm visual analogue scale (VAS, 0-10 cm; 0 means no tinnitus, 10 means extremely severe tinnitus).'}], 'secondaryOutcomes': [{'measure': 'Visual Analogue Scale for cervical pain (VAS-Cervical)', 'timeFrame': 'baseline- 6 week', 'description': 'Pain intensity will be assessed with the visual analogue scale (0-10mm), which has proven validity and reliability for measuring musculoskeletal pain.'}, {'measure': 'Tinnitus Handicap Index (THI)', 'timeFrame': 'baseline- 6 week', 'description': 'The THI contains a total of 25 items with functional (11 items), emotional (9 items) and catastrophic (5 items) subscales. Each item is rated 0 (not affected), 2 (sometimes affected) or 4 (always affected). The total score ranges from 0 to 100, with higher scores indicating higher levels of disability of perceived tinnitus.'}, {'measure': 'Neck disability index (NDI)', 'timeFrame': 'baseline- 6 week', 'description': 'The NDI is designed to assess self-reported neck functional status. The questionnaire consists of 10 items related to pain, activities of daily living, weight lifting, reading, headache, concentration, working status, driving, sleep and recreation and is rated on a 6-point Likert scale ranging from 0 (no disability) to 50 (major disability). Higher scores represent greater disability. The NDI has been found to be reliable and valid for cervical disorders.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tinnitus, Subjective']}, 'descriptionModule': {'briefSummary': 'Somatic tinnitus is an unpleasant perception of sound that occurs in the absence of any external acoustic stimulus. Despite the correct diagnosis of somatic tinnitus, there is currently no specific treatment. The hypothesis of this study is that the application of manual therapy to the cervical region will help to treat tinnitus in patients. This study aims to investigate the effectiveness of manual therapy in the treatment of somatic tinnitus of cervicogenic origin.', 'detailedDescription': 'Somatic tinnitus is an unpleasant perception of sound that occurs in the absence of any external acoustic stimulus. It results from complex interactions between the somatosensory and auditory systems, which involve the musculoskeletal system rather than the ear. The temporomandibular joint, craniocervical junction, cervical vertebrae and neck and shoulder muscles, in particular the sternocleidomastoid (SCM) muscle, upper trapezius and levator scapula, are anatomical regions that can cause somatic tinnitus.\n\nDespite the correct diagnosis of somatic tinnitus, there is currently no specific treatment. The hypothesis of this study is that the application of manual therapy to the cervical region will help to treat tinnitus in patients. This study aims to investigate the effectiveness of manual therapy in the treatment of somatic tinnitus of cervicogenic origin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients aged ≥ 18 and ≤ 65 years Patients fulfilling the clinical criteria4 defined for sevichogenic somatic tinnitus\n\n1. Neck pain\n2. Cervical joint range of motion limitation (especially rotation)\n3. Modulation of tinnitus in relation to head and neck movements and posture\n4. Tenderness in the cervico-occipital muscles Patients reporting cervical pain between \\>2 and \\<7 on a visual analogue scale (VAS) on most days of the last month Patients with stable medical and psychological status Patients willing to participate in the study\n\nExclusion Criteria:\n\nObjective tinnitus Subjective tinnitus with hearing loss Meniere's disease History of vertigo Middle ear pathologies History of intracranial pathology History of whiplash injury History of cervical spinal surgery History of active infection, malignancy, inflammatory rheumatic disease or fibromyalgia Pregnancy Patients who have undergone any exercise or physiotherapy programme for the cervical region in the last 3 months"}, 'identificationModule': {'nctId': 'NCT06433895', 'briefTitle': 'Efficacy of Manual Therapy in the Treatment of Somatic Tinnitus', 'organization': {'class': 'OTHER', 'fullName': 'Gaziler Physical Medicine and Rehabilitation Education and Research Hospital'}, 'officialTitle': 'Efficacy of Manual Therapy in the Treatment of Somatic Tinnitus: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'E2-21-1003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Manual therapy + Exercise group', 'description': 'Both groups will be instructed in the performance of isometric and strengthening exercises for the cervical region, which are provided to patients with cervical pain and limitation as a home programme for a six-week period. Additionally, patients in the manual therapy group will receive manual therapy on a weekly basis for a total of six sessions.', 'interventionNames': ['Other: Manual Therapy', 'Other: Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise group', 'description': 'Both groups will be instructed in the performance of isometric and strengthening exercises for the cervical region, which are provided to patients with cervical pain and limitation as a home programme for a six-week period.', 'interventionNames': ['Other: Exercise']}], 'interventions': [{'name': 'Manual Therapy', 'type': 'OTHER', 'description': 'Manual Therapy', 'armGroupLabels': ['Manual therapy + Exercise group']}, {'name': 'Exercise', 'type': 'OTHER', 'description': 'Isometric and strengthening exercises for the cervical region, which are provided to patients with cervical pain and limitation', 'armGroupLabels': ['Exercise group', 'Manual therapy + Exercise group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gaziler Physical Medicine and Rehabilitation Educiation and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gaziler Physical Medicine and Rehabilitation Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof.', 'investigatorFullName': 'Tuğba Atan, MD', 'investigatorAffiliation': 'Gaziler Physical Medicine and Rehabilitation Education and Research Hospital'}}}}