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NCT Number: NCT07740954

COMPARISON OF MANUAL THERAPY, TINNITUS RETRAINING THERAPY

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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Treatment and study plan

manuel therapy

Behavioral

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.

Other names: procedure

Primary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Ziya Yıldız phd, phd

CONTACT

[email protected]

+9005075077573

EMİNE METİN, phd,

CONTACT

[email protected]

+900 0246-2112773 ext. +9005324201569

Sponsors and collaborators

Lead sponsor

Suleyman Demirel University

Other

Registry information

Official study title

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

Acronym: TINNITUS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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