Modulating Mechanisms in Patients With Chronic Subjective Tinnitus and/or Chronic Pain
Condition: Tinnitus; Pain
MeSH terms: Tinnitus; Chronic Pain
Study type: Interventional

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)
    

Intervention name(s): Self-reported signs of central sensitization; Objective signs of central sensitization; Audiological outcome measures (audiometry, tinnitus analysis, uncomfortable loudness) in tinnitus patients with and without pain; Cognitive functioning; Listening effort; Self-reported psychological factors; Self-reported lifestyle factors; Self-reported measure of pain processing; Self-reported quality of life; Self-reported tinnitus severity and impact on daily life; Self-reported hyperacusis; Self-reported tinnitus characteristics; Self reported neck pain related disability
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): Self-reported signs of central sensitization by means of the Central Sensitization Inventory (questionnaire); Objective signs of central sensitization by means of Quantitative Sensory Testing (mechanical and heat detection and pain thresholds, endogenous pain facilitation and inhibition); 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. .; Evaluation of cognitive functioning by means of:
Auditory Stroop test
Detecting letters task
Letter-number sequencing task; 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) .; 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; Evaluation of lifestyle factors by means of:
Baecke Questionnaire Pittsburg Sleep Quality Index Insomnia Severity Index Stress subscale of the DASS 21; Evaluation of self-reported pain processing by means of the Pain Catastrophizing Scale; Self-reported quality of life by means of the SF-36 questionnaire; Evaluation of self-reported tinnitus severity and impact on daily life by means of the Tinnitus Functional Index; Evaluation of self-reported characteristics of hyperacusis by means of the Hyperacusis Questionnaire; Evaluation of self-reported tinnitus characteristics by means of the Tinnitus Sample Case History Questionnaire; Evaluation of self-reported neck pain related disability using the Neck Disability Index
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening