COMPARISON OF MANUAL THERAPY, TINNITUS RETRAINING THERAPY
TINNITUS
2 other identifiers
interventional
65
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2026
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2026
CompletedFirst Posted
Study publicly available on registry
August 3, 2026
CompletedStudy Start
First participant enrolled
August 12, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2026
Study Completion
Last participant's last visit for all outcomes
December 10, 2026
August 3, 2026
July 1, 2026
4 months
July 22, 2026
July 31, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Baseline and Week 6
Study Arms (3)
Manual Therapy,
EXPERIMENTALParticipants 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 COMPARATORParticipants 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 COMPARATORParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ziya YILDIZ
Isparta University of Applied Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- phd
Study Record Dates
First Submitted
July 22, 2026
First Posted
August 3, 2026
Study Start (Estimated)
August 12, 2026
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
December 10, 2026
Last Updated
August 3, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share