Somatosensory TinnitusTINNITUSNCT07740954
COMPARISON OF MANUAL THERAPY, TINNITUS RETRAINING THERAPY
A study testing Manuel therapy in people with Somatosensory Tinnitus and Subjektif tınnitus, run by Suleyman Demirel University.
Trial summary
This randomized controlled trial aims to compare the effectiveness of Manual Therapy (MT), Tinnitus Retraining Therapy (TRT), and their combination in adults with somatosensory tinnitus. Sixty-five participants will be randomly assigned to one of three parallel groups. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Somatosensory Tinnitus, Subjektif tınnitus
- What is being tested?
- Manuel therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 12 Aug 2026to 10 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18 to 65 years.
- Diagnosis of chronic subjective somatosensory tinnitus persisting for at least 3 months.
- Tinnitus that can be modulated by head, neck, jaw, or temporomandibular movements and/or cervical muscle palpation.
- Ability to understand the study procedures and provide written informed consent.
- Willingness to comply with the treatment protocol and attend all scheduled assessment and treatment sessions.
- Normal middle ear function as confirmed by immittance (tympanometry) testing.
Who cannot join
- Objective or pulsatile tinnitus.
- Tinnitus duration of less than 3 months.
- Diagnosis of Ménière's disease, otosclerosis, vestibular schwannoma (acoustic neuroma), or other retrocochlear pathology.
- Active middle ear disease or abnormal immittance (tympanometry) findings.
- History of cervical spine surgery or severe cervical trauma.
- Presence of cervical spine fracture, instability, malignancy, inflammatory rheumatic disease, or other contraindications to manual therapy.
Show all 13Show fewer
- Previous temporomandibular joint surgery or severe temporomandibular disorders requiring surgical treatment.
- Current participation in another clinical trial.
- Receipt of manual therapy, Tinnitus Retraining Therapy (TRT), or other tinnitus-specific rehabilitation within the previous 3 months.
- Severe neurological or psychiatric disorders that could interfere with participation or outcome assessment.
- Pregnancy.
- Inability to understand study procedures, provide informed consent, or comply with the intervention schedule.
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: COMPARISON OF MANUAL THERAPY, TINNITUS RETRAINING THERAPY, AND COMBINED THERAPY IN PATIENTS WITH SOMATOSENSORY TINNITUS: A THREE-ARM RANDOMİZED CONTROLLED TRIAL
This randomized controlled trial aims to compare the effectiveness of Manual Therapy (MT), Tinnitus Retraining Therapy (TRT), and their combination in adults with somatosensory tinnitus. Sixty-five participants will be randomly assigned to one of three parallel groups. Primary and secondary outcomes include tinnitus severity, tinnitus-related disability, neck disability, cervical range of motion, audiological measures, pressure pain threshold, anxiety, depression, and quality of life. Outcomes will be assessed before treatment and immediately after the six-week intervention period.
- Conditions
- Somatosensory Tinnitus, Subjektif tınnitus
- Being tested
- Manuel therapy
- Keywords
- Tinnitus, Subjective, manuel therapy, tınnıtus retraining therapy, life quality, somatosenrial tınnitus
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manuel therapyBehavioural
Also called procedure
This study is a prospective, single-center, assessor-blinded, three-arm, parallel-group randomized controlled trial designed to compare the effectiveness of Tinnitus Retraining Therapy (TRT), Manual Therapy (MT), and the combination of TRT plus MT in adults with somatosensory tinnitus. Participants will be randomly assigned in a 1:1:1 ratio using a computer-generated block randomization sequence. Allocation concealment will be ensured using the sequence.
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy, | Experimental | Participants assigned to this group will receive manual therapy targeting the cervical spine and temporomandibular region. Treatment will include soft tissue mobilization, trigger point release, joint mobilization, stretching, and other manual techniques as indicated. Participants will receive 12 treatment sessions over a 6-week period. Receives: Behavioral: Manuel therapy |
| Tinnitus Retraining Therapy | Active comparator | Participants assigned to this group will receive Tinnitus Retraining Therapy (TRT), consisting of directive counseling and individualized sound therapy. The intervention will be delivered over 12 sessions during a 6-week treatment period. Receives: Behavioral: Manuel therapy |
| Combined Manual Therapy and Tinnitus Retraining Therapy | Active comparator | Participants assigned to this group will receive both manual therapy and Tinnitus Retraining Therapy (TRT). Manual therapy will target the cervical spine and temporomandibular region, while TRT will consist of directive counseling and individualized sound therapy. Participants will receive 12 treatment sessions over a 6-week period. Receives: Behavioral: Manuel therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The TPFQ is a validated patient-reported questionnaire
The TPFQ is a validated patient-reported questionnaire used to assess tinnitus severity and its functional impact. Higher scores indicate greater tinnitus-related impairm
Measured: Baseline and Week 6 (end of treatment)
The THI is a validated questionnaire
The THI is a validated questionnaire assessing the degree of tinnitus-related handicap. Higher scores indicate greater tinnitus-re
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start12 Aug 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
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 Somatosensory TinnitusStudies 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
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Emine Metin, phd, Suleyman Demirel University
- Investigators
- ziya YILDIZ, Study director, Isparta University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740954
- Sponsor's protocol ID
- SuleymanDU3
- Other IDs
- ISUBU-E281236
- Acronym
- TINNITUS
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Michiels S, Van de Heyning P, Truijen S, Hallemans A, De Hertogh W. Does multi-modal cervical physical therapy improve tinnitus in patients with cervicogenic somatic tinnitus? Man Ther. 2016;26:125-131. 2. Kleinjung T, Peter N, Schecklmann M, Langguth B. The current state of tinnitus diagnosis and treatment: a multidisciplinary expert perspective. JARO: Journal of the Association for Research in Otolaryngology. 2024;25(5):413. 3. Kinne B, Bays L, Fahlen K, Owens J. Somatic tinnitus and manual therapy: a systematic review. J Phy Med Rehab. 2018;2:111. 4. Atan D, Atan T, Çakır Ağca BN, Güzelküçük Ü. Effectiveness of manual therapy in the treatment of somatic tinnitus: a randomized controlled trial. Physiother Theory Pract. 2026:1-11. 5. Michiels S, Wölflick S, Simões J, Schlee W. Exploring app-based physiotherapy for somatic tinnitus: results from a pilot study. Journal of Clinical Medicine. 2024;13(23):7203. 6. Bökel A, Fobbe A, Lesinski-Schiedat A, Sturm C. Exploring the Effects of Manual Therapy on Somatosensory Tinnitus and Dizziness: A Randomized Controlled Trial. Journal of Clinical Medicine. 2025;14(13):4579. 7. Sanchez TG, Rocha CB. Diagnosis and management of somatosensory tinnitus. Clinics. 2011;66(6):1089-1094. 8. Phillips JS, McFerran D. Tinnitus retraining therapy (TRT) for tinnitus. The Cochrane database of systematic reviews. 2010;2010(3):CD007330. 9. Ostermann K, Lurquin P, Horoi M, Cotton P, Herve V, Thill M. Somatic tinnitus prevalence and treatment with tinnitus retraining therapy. B-ENT. 2016;12(1):59-65. 10. Michiels S, De Hertogh W, Truijen S, Van de Heyning P. Physical therapy treatment in patients suffering from cervicogenic somatic tinnitus: study protocol for a randomized controlled trial. Trials. 2014;15(1):297. 11. Öcal FCA, Bozkurt HK, Ünlü CE, Tyler R, Satar B. Validity of the Turkish version of the tinnitus primary function questionnaire. Turkish archives of otorhinolaryngology. 2025;62(4):145. 12. Aksoy S, Firat Y, Alpar R
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF MANUAL THERAPY, TINNITUS RETRAINING THERAPY, AND COMBINED THERAPY IN PATIENTS WITH SOMATOSENSORY TINNITUS: A THREE-ARM RANDOMİZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT07740954
- Acronym / sponsor ID
- TINNITUS / SuleymanDU3
- Conditions
- Somatosensory Tinnitus, Subjektif tınnitus
- Keywords
- Tinnitus, Subjective, manuel therapy, tınnıtus retraining therapy, life quality, somatosenrial tınnitus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 12 Aug 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 3 Aug 2026 (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.
This randomized controlled trial aims to compare the effectiveness of Manual Therapy (MT), Tinnitus Retraining Therapy (TRT), and their combination in adults with somatosensory tinnitus. Sixty-five participants will be randomly assigned to one of three parallel groups. Primary and secondary outcomes include tinnitus severity, tinnitus-related disability, neck disability, cervical range of motion, audiological measures, pressure pain threshold, anxiety, depression, and quality of life. Outcomes will be assessed before treatment and immediately after the six-week intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy, | Experimental | Behavioral: Manuel therapyParticipants assigned to this group will receive manual therapy targeting the cervical spine and temporomandibular region. Treatment will include soft tissue mobilization, trigger point release, joint mobilization, stretching, and other manual techniques as indicated. Participants will receive 12 treatment sessions over a 6-week period. |
| Tinnitus Retraining Therapy | Active comparator | Behavioral: Manuel therapyParticipants assigned to this group will receive Tinnitus Retraining Therapy (TRT), consisting of directive counseling and individualized sound therapy. The intervention will be delivered over 12 sessions during a 6-week treatment period. |
| Combined Manual Therapy and Tinnitus Retraining Therapy | Active comparator | Behavioral: Manuel therapyParticipants assigned to this group will receive both manual therapy and Tinnitus Retraining Therapy (TRT). Manual therapy will target the cervical spine and temporomandibular region, while TRT will consist of directive counseling and individualized sound therapy. Participants will receive 12 treatment sessions over a 6-week period. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults aged 18 to 65 years.
- Diagnosis of chronic subjective somatosensory tinnitus persisting for at least 3 months.
- Tinnitus that can be modulated by head, neck, jaw, or temporomandibular movements and/or cervical muscle palpation.
- Ability to understand the study procedures and provide written informed consent.
- Willingness to comply with the treatment protocol and attend all scheduled assessment and treatment sessions.
Key exclusion criteria (13 listed)
- Objective or pulsatile tinnitus.
- Tinnitus duration of less than 3 months.
- Diagnosis of Ménière's disease, otosclerosis, vestibular schwannoma (acoustic neuroma), or other retrocochlear pathology.
- Active middle ear disease or abnormal immittance (tympanometry) findings.
- History of cervical spine surgery or severe cervical trauma.
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 |
|---|---|---|
| Manuel therapyAlso: procedureThis study is a prospective, single-center, assessor-blinded, three-arm, parallel-group randomized controlled trial designed to compare the effectiveness of Tinnitus Retraining Therapy (TRT), Manual Therapy (MT), and the combination of TRT plus MT in adults with somatosensory tinnitus. Participants will be randomly assigned in a 1:1:1 ratio using a computer-generated block randomization sequence. Allocation concealment will be ensured using the sequence. | Behavioural | Combined Manual Therapy and Tinnitus Retraining Therapy, Manual Therapy,, Tinnitus Retraining Therapy |
Primary outcome
The TPFQ is a validated patient-reported questionnaire
Time frame: Baseline and Week 6 (end of treatment)
The TPFQ is a validated patient-reported questionnaire used to assess tinnitus severity and its functional impact. Higher scores indicate greater tinnitus-related impairm
The THI is a validated questionnaire
Time frame: Baseline and Week 6
The THI is a validated questionnaire assessing the degree of tinnitus-related handicap. Higher scores indicate greater tinnitus-re
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Background1. Michiels S, Van de Heyning P, Truijen S, Hallemans A, De Hertogh W. Does multi-modal cervical physical therapy improve tinnitus in patients with cervicogenic somatic tinnitus? Man Ther. 2016;26:125-131. 2. Kleinjung T, Peter N, Schecklmann M, Langguth B. The current state of tinnitus diagnosis and treatment: a multidisciplinary expert perspective. JARO: Journal of the Association for Research in Otolaryngology. 2024;25(5):413. 3. Kinne B, Bays L, Fahlen K, Owens J. Somatic tinnitus and manual therapy: a systematic review. J Phy Med Rehab. 2018;2:111. 4. Atan D, Atan T, Çakır Ağca BN, Güzelküçük Ü. Effectiveness of manual therapy in the treatment of somatic tinnitus: a randomized controlled trial. Physiother Theory Pract. 2026:1-11. 5. Michiels S, Wölflick S, Simões J, Schlee W. Exploring app-based physiotherapy for somatic tinnitus: results from a pilot study. Journal of Clinical Medicine. 2024;13(23):7203. 6. Bökel A, Fobbe A, Lesinski-Schiedat A, Sturm C. Exploring the Effects of Manual Therapy on Somatosensory Tinnitus and Dizziness: A Randomized Controlled Trial. Journal of Clinical Medicine. 2025;14(13):4579. 7. Sanchez TG, Rocha CB. Diagnosis and management of somatosensory tinnitus. Clinics. 2011;66(6):1089-1094. 8. Phillips JS, McFerran D. Tinnitus retraining therapy (TRT) for tinnitus. The Cochrane database of systematic reviews. 2010;2010(3):CD007330. 9. Ostermann K, Lurquin P, Horoi M, Cotton P, Herve V, Thill M. Somatic tinnitus prevalence and treatment with tinnitus retraining therapy. B-ENT. 2016;12(1):59-65. 10. Michiels S, De Hertogh W, Truijen S, Van de Heyning P. Physical therapy treatment in patients suffering from cervicogenic somatic tinnitus: study protocol for a randomized controlled trial. Trials. 2014;15(1):297. 11. Öcal FCA, Bozkurt HK, Ünlü CE, Tyler R, Satar B. Validity of the Turkish version of the tinnitus primary function questionnaire. Turkish archives of otorhinolaryngology. 2025;62(4):145. 12. Aksoy S, Firat Y, Alpar R
- Individual participant dataSharing planned: No
Related trials for Somatosensory Tinnitus
Recruiting
Somatosensory Tinnitus RCT
Tinnitus
Not yet recruiting
Multimodal Therapy for Somatosensory Tinnitus
Ear Noise, Tinnitus, Noise Induced
Not yet recruitingObservational study
CBCT and Audiological Analysis of the TMJ-Tinnitus Relationship
Tinnitus, Temporomandibular Joint Disorders
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.
ziya YILDIZ study director
Isparta University of Applied Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Manuel therapy in people with Somatosensory Tinnitus and Subjektif tınnitus, run by Suleyman Demirel University.
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 6 inclusion and 13 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: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact EMİNE METİN, phd, (+900 0246-2112773 ext. +9005324201569, eminetaha32@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The TPFQ is a validated patient-reported questionnaire (time frame: Baseline and Week 6 (end of treatment)). The study lists 2 primary outcomes in all. 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 NCT07740954, 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 3 Aug 2026.