Clinical trial NCT06433895: Efficacy of Manual Therapy in the Treatment of Somatic Tinnitus
Official title: Efficacy of Manual Therapy in the Treatment of Somatic Tinnitus: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tinnitus, Subjective
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual Analogue Scale for Tinnitus (VAS-tinnitus)
timeFrame: baseline- 6 week
Secondary outcomes:
measure: Visual Analogue Scale for cervical pain (VAS-Cervical)
timeFrame: baseline- 6 week
measure: Tinnitus Handicap Index (THI)
timeFrame: baseline- 6 week
measure: Neck disability index (NDI)
timeFrame: baseline- 6 week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gaziler Physical Medicine and Rehabilitation Educiation and Research Hospital
Study officials:
References: