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Table 2 Overview of primary and secondary outcome measures

From: Conservative therapy for the treatment of patients with somatic tinnitus attributed to temporomandibular dysfunction: study protocol of a randomised controlled trial

 

Baseline

Follow-up

Measuring tool

Completed by

Primary outcome measure

 Tinnitus-related distress

X

X

Tinnitus Questionnaire

Patient

Secondary outcome measure

 TMJ pain

X

X

TMD pain screener

Patient

 Myalgia

X

X

DC/TMD

Researcher

 Arthralgia

X

X

DC/ TMD

Researcher

 Pressure sensitivity

X

X

Pressure algometer (Somedic), kPa

Researcher

 Mouth opening

X

X

Ruler, cm

Researcher

 Hearing loss

X

 

Pure Tone audiometry

Speech in noise test

Audiologist

 Psychoacoustic tinnitus analysis

X

X

Type of tinnitus, tinnitus pitch and tinnitus loudness

Audiologist

 Tinnitus severity

X

 

Tinnitus Functional Index

Patient

 Subjective tinnitus loudness

X

X

Visual Analogue Scale (0–100 mm)

Patient

 State of anxiety and depression

X

 

Hospital Anxiety and Depression Scale

Patient

 Hyperacusis

X

 

Hyperacusis Questionnaire

Patient

 Auditory event-related potential

X

X

Auditory event-related potential

Researcher

 General tinnitus characteristics such as duration of the complaints, localisation (unilateral, bilateral, central), somatic modulation, temporal relation with TMD, bruxism periods

X

 

Medical history

ENT

  1. DC/TMD Diagnostic criteria for temporomandibular disorders, ENT ear-nose-throat, TMD temporomandibular disorders, TMJ temporomandibular joint