Skip to content

Efficacy of Manual Therapy in the Treatment of Somatic Tinnitus

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06433895
Enrollment
31
Registered
2024-05-30
Start date
2024-05-25
Completion date
2025-06-25
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus, Subjective

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.

Interventions

OTHERManual Therapy

Manual Therapy

OTHERExercise

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

Sponsors

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogue Scale for Tinnitus (VAS-tinnitus)baseline- week 3 - week 6The 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).

Secondary

MeasureTime frameDescription
Visual Analogue Scale for cervical pain (VAS-Cervical)baseline- week 3 - week 6Pain intensity will be assessed with the visual analogue scale (0-10mm), which has proven validity and reliability for measuring musculoskeletal pain.
Tinnitus Handicap Index (THI)baseline- week 3 - week 6The 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.
Neck disability index (NDI)baseline- week 3 - week 6The 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.
Cervical range of motion (ROM)baseline -week 3- week 6Cervical range of motion (ROM)
Manual muscle testing (MMT)baseline - week 3 -week 6MMT for assessing strength of cervical flexors, extensors, lateral flexors, and rotators
Myofascial trigger point of the SCM, upper trapezius, levator scapulae, splenius capitisbaseline- week 3- week 6Myofascial trigger point of the SCM, upper trapezius, levator scapulae, splenius capitis
Tinnitus provocation with ROMBaseline- week 3- week 6Tinnitus provocation with ROM
Tinnitus provocation with MMTBaseline- week 3- week 6Tinnitus provocation with MMT
Tinnitus provocation with myofascial trigger point palpationBaseline- week 3- week 6Tinnitus provocation with myofascial trigger point palpation
SF-36 quality of life scoresBaseline- week 3- week 6SF-36 is a widely validated and reliable generic measure of health-related quality of life, covering eight domains: physical functioning, role limitations due to physical and emotional problems, pain, general health, vitality, social functioning, and mental health. Each subscale score ranges from 0 (worst) to 100 (best)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026