COMPARISON OF MANUAL THERAPY, TINNITUS RETRAINING THERAPY
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorSuleyman Demirel University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Manuel therapy
BehavioralThis 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.
Treatment groups
65 Participants
are divided into 3 treatment groupsGroup A: Manual Therapy,Experimental treatment 1 intervention
Group B: Tinnitus Retraining TherapyActive comparator 1 intervention
Group C: Combined Manual Therapy and Tinnitus Retraining TherapyActive comparator 1 intervention
Trial outcomes
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 6Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: