Tinnitus, SubjectiveNCT06433895
Efficacy of Manual Therapy in the Treatment of Somatic Tinnitus
A study testing Manual Therapy and Exercise in people with Tinnitus, Subjective, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tinnitus, Subjective
- What is being tested?
- Manual Therapy and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 May 2024to 25 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziler Physical Medicine and Rehabilitation Educiation and Research Hospital
Ankara
About this study
Official title: Efficacy of Manual Therapy in the Treatment of Somatic Tinnitus: A Randomised Controlled Trial
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.
Read the 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
- Being tested
- Manual Therapy, Exercise
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual TherapyOther
Manual Therapy
ExerciseOther
Isometric and strengthening exercises for the cervical region, which are provided to patients with cervical pain and limitation
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy + Exercise group | Experimental | 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. Receives: Other: Manual Therapy; Other: Exercise |
| Exercise group | Active comparator | 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. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline- week 3 - week 6
Secondary outcomes (10)
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.
Measured: baseline- week 3 - week 6
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.
Measured: baseline- week 3 - week 6
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.
Measured: baseline- week 3 - week 6
Cervical range of motion (ROM)
Cervical range of motion (ROM)
Measured: baseline -week 3- week 6
Manual muscle testing (MMT)
MMT for assessing strength of cervical flexors, extensors, lateral flexors, and rotators
Measured: baseline - week 3 -week 6
Myofascial trigger point of the SCM, upper trapezius, levator scapulae, splenius capitis
Myofascial trigger point of the SCM, upper trapezius, levator scapulae, splenius capitis
Measured: baseline- week 3- week 6
Tinnitus provocation with ROM
Tinnitus provocation with ROM
Measured: Baseline- week 3- week 6
Tinnitus provocation with MMT
Tinnitus provocation with MMT
Measured: Baseline- week 3- week 6
Tinnitus provocation with myofascial trigger point palpation
Tinnitus provocation with myofascial trigger point palpation
Measured: Baseline- week 3- week 6
SF-36 quality of life scores
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)
Measured: Baseline- week 3- week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start25 May 2024
- Primary completion25 Jun 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tinnitus, SubjectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Atan, MD, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433895
- Sponsor's protocol ID
- E2-21-1003
- Status last verified
- Feb 2026
- First submitted
- 23 May 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Atan D, Atan T, Cakir Agca BN, Guzelkucuk U. Effectiveness of manual therapy in the treatment of somatic tinnitus: a randomized controlled trial. Physiother Theory Pract. 2026 Mar 21:1-11. doi: 10.1080/09593985.2026.2647791. Online ahead of print.
PubMed 41863305
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Manual Therapy in the Treatment of Somatic Tinnitus: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06433895
- Acronym / sponsor ID
- E2-21-1003
- Conditions
- Tinnitus, Subjective
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 25 May 2024 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual therapy + Exercise group | Experimental | Other: Manual Therapy, Other: ExerciseBoth 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. |
| Exercise group | Active comparator | Other: ExerciseBoth 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual TherapyManual Therapy | Other | Manual therapy + Exercise group |
| ExerciseIsometric and strengthening exercises for the cervical region, which are provided to patients with cervical pain and limitation | Other | Exercise group, Manual therapy + Exercise group |
Primary outcome
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).
10 secondary outcomes
Visual Analogue Scale for cervical pain (VAS-Cervical)
Time frame: baseline- week 3 - week 6
Tinnitus Handicap Index (THI)
Time frame: baseline- week 3 - week 6
Neck disability index (NDI)
Time frame: baseline- week 3 - week 6
Cervical range of motion (ROM)
Time frame: baseline -week 3- week 6
Manual muscle testing (MMT)
Time frame: baseline - week 3 -week 6
Myofascial trigger point of the SCM, upper trapezius, levator scapulae, splenius capitis
Time frame: baseline- week 3- week 6
Tinnitus provocation with ROM
Time frame: Baseline- week 3- week 6
Tinnitus provocation with MMT
Time frame: Baseline- week 3- week 6
Tinnitus provocation with myofascial trigger point palpation
Time frame: Baseline- week 3- week 6
SF-36 quality of life scores
Time frame: Baseline- week 3- week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Derived from this study: PubMed 41863305Atan D, Atan T, Cakir Agca BN, Guzelkucuk U. Effectiveness of manual therapy in the treatment of somatic tinnitus: a randomized controlled trial. Physiother Theory Pract. 2026 Mar 21:1-11. doi: 10.1080/09593985.2026.2647791. Online ahead of print.
- Individual participant dataSharing planned: No
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COMPARISON OF MANUAL THERAPY, TINNITUS RETRAINING THERAPY
Somatosensory Tinnitus, Subjektif tınnitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy and Exercise in people with Tinnitus, Subjective, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale for Tinnitus (VAS-tinnitus) (time frame: baseline- week 3 - week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06433895, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.