Efficacy of Manual Therapy in the Treatment of Somatic Tinnitus

Tinnitus, Subjective Clinical Trial

Official title:

Efficacy of Manual Therapy in the Treatment of Somatic Tinnitus: A Randomised Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06433895
• Other study ID #: E2-21-1003
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 25, 2024
• Est. completion date: December 25, 2024

Study information

• Verified date: May 2024
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 25, 2024
• Est. primary completion date: December 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Patients aged = 18 and = 65 years Patients fulfilling the clinical criteria4 defined for sevichogenic somatic tinnitus

1. Neck pain

2. Cervical joint range of motion limitation (especially rotation)

3. Modulation of tinnitus in relation to head and neck movements and posture

4. 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 Exclusion Criteria: Patients with objective tinnitus Patients with subjective tinnitus with hearing loss Patients with Meniere's disease Patients with a history of vertigo Patients with middle ear pathologies Patients with a history of intracranial pathology Patients with a history of whiplash injury Patients with a history of cervical spinal surgery Patients with a 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

Related Conditions & MeSH terms

• Tinnitus
• Tinnitus, Subjective

Intervention

Other:
• Manual Therapy
Manual Therapy
• Exercise
Isometric and strengthening exercises for the cervical region, which are provided to patients with cervical pain and limitation

Locations

Country	Name	City	State
Turkey	Gaziler Physical Medicine and Rehabilitation Educiation and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale for Tinnitus (VAS-tinnitus)	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).	baseline- 6 week
Secondary	Visual Analogue Scale for cervical pain (VAS-Cervical)	Pain intensity will be assessed with the visual analogue scale (0-10mm), which has proven validity and reliability for measuring musculoskeletal pain.	baseline- 6 week
Secondary	Tinnitus Handicap Index (THI)	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.	baseline- 6 week
Secondary	Neck disability index (NDI)	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.	baseline- 6 week