Efficacy of Manual Therapy in the Treatment of Somatic Tinnitus

NCT ID: NCT06433895

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-25
• Study Completion Date: 2025-06-25

Brief 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.

Detailed 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.

Conditions

Tinnitus, Subjective

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Manual therapy + Exercise group

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.

Group Type: EXPERIMENTAL

Manual Therapy

Intervention Type: OTHER

Manual Therapy

Exercise

Intervention Type: OTHER

Isometric and strengthening exercises for the cervical region, which are provided to patients with cervical pain and limitation

Exercise group

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.

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: OTHER

Isometric and strengthening exercises for the cervical region, which are provided to patients with cervical pain and limitation

Interventions

Manual Therapy

Manual Therapy

Intervention Type: OTHER

Exercise

Isometric and strengthening exercises for the cervical region, which are provided to patients with cervical pain and limitation

Intervention Type: OTHER

Eligibility Criteria

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

Objective 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tuğba Atan, MD

Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gaziler Physical Medicine and Rehabilitation Educiation and Research Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E2-21-1003

Identifier Type: -

Identifier Source: org_study_id