NCT05186259

Modulating Mechanisms in Patients With Chronic Subjective Tinnitus and/or Chronic Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: University Ghent · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a cross-sectional investigation into modulating mechanisms in patients with chronic subjective tinnitus, which will compare 4 patient groups namely chronic tinnitus with chronic pain, chronic tinnitus without chronic pain, chronic pain without tinnitus and healthy controls.

Detailed description

The first aim is to investigate differences in pain-related factors, psychological factors, lifestyle factors and tinnitus-related factors in patients with chronic subjective tinnitus and the comparison with patients suffering from both chronic subjective tinnitus and chronic musculoskeletal pain, chronic musculoskeletal pain only and healthy controls. The primary outcome measures will be pain-related factors and correlations will also be calculated between pain-related factors on the one hand and psychological factors, lifestyle factors and tinnitus-related factors on the other hand. A second aim is to assess contributing factors to tinnitus severity (measured by the Tinnitus Functional Index) in patients with tinnitus with or without chronic pain. Contributing factors will include pain-related factors, psychological factors, lifestyle factors, and tinnitus-related factors, audiological factors, cognitive factors. * Pain-related factors include: 1. Self-perceived symptoms of central sensitization by means of the Central Sensitization Inventory: The Central Sensitization Inventory is a self-report questionnaire that assesses clinical symptoms indicative for central sensitization. 2. Experimental measures of central sensitization: Quantitative Sensory Testing Quantitative Sensory Testing (QST) is a psychophysiological assessment of sensory pathways including mechanicaldetection and pain thresholds, cutaneous heat detection and pain thresholds, and endogenous pain facilitation and inhibition. 3. Self-reported pain processing by means of the Pain Catastrophizing Scale 4. Self-reported neck pain related disability by means of the Neck Disability Index * Psychological factors include: Self-reported stress, anxiety and depression (Depression, Anxiety and Stress Scale\_21 and Beck Depression Inventory), resilience (Connor Davidson Resilience Scale), personality (Big Five Index) \*Lifestyle factors include: Self-reported physical activity (Baecke Questionnaire), self-reported sleep quality (Pittsburgh Sleep Quality Index) and self-reported insomnia severity (Insomnia Severity Index), self-reported quality of life (SF-36) \*Tinnitus-related factors include: Self-reported tinnitus severity and impact (Tinnitus Functional Index), self-reported hyperacusis (Hyperacusis Questionnare), self-reported tinnitus characteristics (Tinnitus Sample Case History Questionnaire) * Cognitive factors include: 1. Verbal working memory capacity and processing speed (Letter-number sequencing task) 2. Attention span (detecting letters-task (COTESS)) 3. Cognitive flexibility and inhibition (Auditory Stroop task) 4. Listening effort (Modified version of the behavioral listening effort test based on a dual-task paradigm by Degeest, Keppler \& Corthals (2018)) * Audiological factors include: 1. Hearing thresholds (Pure tone audiometry) 2. Psychoacoustic features of tinnitus (tinnitus pitch, loudness, masking ability, and residual inhibition using same devices as for pure tone audiometry) 3. Uncomfortable Loudness (using same devices as for pure tone audiometry)

Conditions

• Tinnitus
• Pain

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Self-reported signs of central sensitization	Self-reported signs of central sensitization by means of the Central Sensitization Inventory (questionnaire)
DIAGNOSTIC_TEST	Objective signs of central sensitization	Objective signs of central sensitization by means of Quantitative Sensory Testing (mechanical and heat detection and pain thresholds, endogenous pain facilitation and inhibition)
DIAGNOSTIC_TEST	Audiological outcome measures (audiometry, tinnitus analysis, uncomfortable loudness) in tinnitus patients with and without pain	* Audiometry Performance of pure tone audiometry according to the modified Hughson-Westlake method * Tinnitus analysis Measurement of psychoacoustic features of tinnitus, including (1) tinnitus pitch, (2) loudness, (3) masking ability, and (4) residual inhibition. * Uncomfortable Loudness measures Performance of Uncomfortable Loudness measurements to evaluate the presence of hyperacusis. .
DIAGNOSTIC_TEST	Cognitive functioning	Evaluation of cognitive functioning by means of: * Auditory Stroop test * Detecting letters task * Letter-number sequencing task
DIAGNOSTIC_TEST	Listening effort	Evaluation of listening effort by means of the modified version of the behavioral listening effort test based on a dual-task paradigm by Degeest, Keppler \& Corthals (2018) .
DIAGNOSTIC_TEST	Self-reported psychological factors	Evaluation of psychological factors by means of: * Depression, Anxiety and Stress Scale (DASS-21) * Beck Depression Inventory (BDI) * Big Five Inventory (BFI) * Connor-Davidson Resilience Scale
DIAGNOSTIC_TEST	Self-reported lifestyle factors	Evaluation of lifestyle factors by means of: Baecke Questionnaire Pittsburg Sleep Quality Index Insomnia Severity Index Stress subscale of the DASS 21
DIAGNOSTIC_TEST	Self-reported measure of pain processing	Evaluation of self-reported pain processing by means of the Pain Catastrophizing Scale
DIAGNOSTIC_TEST	Self-reported quality of life	Self-reported quality of life by means of the SF-36 questionnaire
DIAGNOSTIC_TEST	Self-reported tinnitus severity and impact on daily life	Evaluation of self-reported tinnitus severity and impact on daily life by means of the Tinnitus Functional Index
DIAGNOSTIC_TEST	Self-reported hyperacusis	Evaluation of self-reported characteristics of hyperacusis by means of the Hyperacusis Questionnaire
DIAGNOSTIC_TEST	Self-reported tinnitus characteristics	Evaluation of self-reported tinnitus characteristics by means of the Tinnitus Sample Case History Questionnaire
DIAGNOSTIC_TEST	Self reported neck pain related disability	Evaluation of self-reported neck pain related disability using the Neck Disability Index

Timeline

• Start date: 2021-12-21
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2022-01-11
• Last updated: 2024-01-09

Locations

1 site across 1 country: Belgium