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COMPARISON OF MANUAL THERAPY, TINNITUS RETRAINING THERAPY

COMPARISON OF MANUAL THERAPY, TINNITUS RETRAINING THERAPY, AND COMBINED THERAPY IN PATIENTS WITH SOMATOSENSORY TINNITUS: A THREE-ARM RANDOMİZED CONTROLLED TRIAL

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07740954
Acronym
TINNITUS
Enrollment
65
Registered
2026-08-03
Start date
2026-08-12
Completion date
2026-12-10
Last updated
2026-08-03

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

Conditions

Somatosensory Tinnitus, Subjektif tınnitus

Keywords

Tinnitus, Subjective, manuel therapy, tınnıtus retraining therapy, life quality, somatosenrial tınnitus

Brief 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.

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.

Sponsors

Suleyman Demirel University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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 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.

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, malignancy, inflammatory rheumatic disease, or other contraindications 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 informed consent, or comply with the intervention schedule. \-

Design outcomes

Primary

MeasureTime frameDescription
The TPFQ is a validated patient-reported questionnaireBaseline 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 questionnaireBaseline and Week 6The THI is a validated questionnaire assessing the degree of tinnitus-related handicap. Higher scores indicate greater tinnitus-re

Contacts

CONTACTEMİNE METİN, phd,
eminetaha32@gmail.com+900 0246-2112773
CONTACTDr. Ziya Yıldız phd, phd
eminetaha32@gmail.com+9005075077573
STUDY_DIRECTORziya YILDIZ

Isparta University of Applied Sciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 4, 2026