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Not yet recruitingNCT07740954TINNITUSUpdated Aug 3, 2026

COMPARISON OF MANUAL THERAPY, TINNITUS RETRAINING THERAPY

An interventional study of Manuel therapy in Somatosensory Tinnitus and Subjektif tınnitus, sponsored by Suleyman Demirel University. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by Suleyman Demirel University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Somatosensory Tinnitus
  • Subjektif tınnitus

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Keywords

  • Tinnitus, Subjective
  • manuel therapy
  • tınnıtus retraining therapy
  • life quality
  • somatosenrial tınnitus
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In context

Tinnitus

444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.

This study's planned enrollment of 65 is close to the median of 60 across 368 interventional studies indexed under Tinnitus.

Browse Tinnitus studies →

Lead sponsor

Suleyman Demirel University is the lead sponsor of 127 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 .
  • 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.

Exclusion criteria

Exclusion Criteria:

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, , inflammatory rheumatic disease, or other to manual therapy.
  • 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 , or comply with the intervention schedule.

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Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
65 participants (estimated)

Study arms

  • Experimental
    Manual Therapy,

    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.

    Behavioral: Manuel therapy

  • Active comparator
    Tinnitus Retraining Therapy

    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.

    Behavioral: Manuel therapy

  • Active comparator
    Combined Manual Therapy and Tinnitus Retraining Therapy

    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.

    Behavioral: Manuel therapy

Interventions

  • BehavioralManuel therapy

    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.

    Also known as: procedure

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline and Week 6 (end of treatment)

  2. 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

    Time frame: Baseline and Week 6

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Study locations

No study locations are listed for this record.

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References and documents

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

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Nov 2026, 3 months later.

Of 133 non-industry interventional studies with no phase under Tinnitus, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 3 months is below that.

Counting every sponsor, half of 151 studies reached it within 17 months; a quarter within 10 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 22, 2026
First posted
Aug 3, 2026
StartEst.
Aug 12, 2026
Primary completionEst.
Nov 30, 2026
CompletionEst.
Dec 10, 2026
Last update
Aug 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07740954
Responsible party
Dr. Emine Metin, phd (phd, Suleyman Demirel University) — Principal investigator
First posted
Aug 3, 2026
Start date
Aug 12, 2026 (estimated)
Primary completion
Nov 30, 2026 (estimated)
Completion
Dec 10, 2026 (estimated)
Last update
Aug 3, 2026

Study contacts

EMİNE METİN, phd,
Contact
eminetaha32@gmail.com
+900 0246-2112773 ext. +9005324201569
Dr. Ziya Yıldız phd, phd
Contact
eminetaha32@gmail.com
+9005075077573
ziya YILDIZ
study director · Isparta University of Applied Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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