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Completed

NCT Number: NCT06433895

Efficacy of Manual Therapy in the Treatment of Somatic Tinnitus

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaziler Physical Medicine and Rehabilitation Educiation and Research Hospital

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • Neck pain
  • Cervical joint range of motion limitation (especially rotation)
  • Modulation of tinnitus in relation to head and neck movements and posture
  • 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

Treatment and study plan

Manual therapy

Other

Manual Therapy

Exercise

Other

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

Primary outcomes

  1. Visual Analogue Scale for Tinnitus (VAS-tinnitus)

    Time frame: baseline- week 3 - week 6

    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).

Secondary outcomes

  1. Visual Analogue Scale for cervical pain (VAS-Cervical)

    Time frame: baseline- week 3 - week 6

    Pain intensity will be assessed with the visual analogue scale (0-10mm), which has proven validity and reliability for measuring musculoskeletal pain.

  2. Tinnitus Handicap Index (THI)

    Time frame: baseline- week 3 - week 6

    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.

  3. Neck disability index (NDI)

    Time frame: baseline- week 3 - week 6

    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.

  4. Cervical range of motion (ROM)

    Time frame: baseline -week 3- week 6

    Cervical range of motion (ROM)

  5. Manual muscle testing (MMT)

    Time frame: baseline - week 3 -week 6

    MMT for assessing strength of cervical flexors, extensors, lateral flexors, and rotators

  6. Myofascial trigger point of the SCM, upper trapezius, levator scapulae, splenius capitis

    Time frame: baseline- week 3- week 6

    Myofascial trigger point of the SCM, upper trapezius, levator scapulae, splenius capitis

  7. Tinnitus provocation with ROM

    Time frame: Baseline- week 3- week 6

    Tinnitus provocation with ROM

  8. Tinnitus provocation with MMT

    Time frame: Baseline- week 3- week 6

    Tinnitus provocation with MMT

  9. Tinnitus provocation with myofascial trigger point palpation

    Time frame: Baseline- week 3- week 6

    Tinnitus provocation with myofascial trigger point palpation

  10. SF-36 quality of life scores

    Time frame: Baseline- week 3- week 6

    SF-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)

Sponsors and collaborators

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 30, 2024
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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