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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    200
  • sponsor
    University Ghent
Updated on 7 October 2022
heat
depression
anxiety
chronic pain
insomnia
audiometry
pure tone audiometry
pulsatile tinnitus
hyperacusis
Accepts healthy volunteers

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.

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)

Details
Condition Tinnitus, Pain
Treatment Cognitive Functioning, 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, 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
Clinical Study IdentifierNCT05186259
SponsorUniversity Ghent
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged between 18-65 years
Chronic subjective tinnitus (> 3 months during most of the days (4 or more)and for more than 5 minutes/day)
Speaking and understanding Dutch fluently
Chronic subjective tinnitus patients with chronic pain
Aged between 18-65 years
Chronic ideopathic neck pain
Chronic subjective tinnitus (> 3 months during most of the days (4 or more)and for more than 5 minutes/day)
Speaking and understanding Dutch fluently
Persistent musculoskeletal pain lasting more than 3 months
Mean pain intensity of more than 3 of 10 on a numeric pain rating scale during the preceding month (the cutoff for clinically relevant pain)
Aged between 18-65 years
Healthy controls
Persistent neck pain lasting more than 3 months
Mean pain intensity of more than 3 of 10 on a numeric pain rating scale during the preceding month (the cutoff for clinically relevant pain)
Aged between 18-65 years

Exclusion Criteria

Chronic subjective tinnitus with/without chronic pain
Objective tinnitus
Subjective tinnitus caused by clear causes such as tumor, trauma, vascular dysfunction, neurological disorder, pulsatile tinnitus
Vertigo (Menière's disease, BPPV,…)
Deafness
Progressive middle ear pathology
Intracranial pathologies
Chronic ideopathic neck pain
Subjects with prior otologic surgery (for example stapedotomy), active outer or middle ear pathology
History of head, neck or shoulder trauma or surgery (< 5 years, or remaining complaints)
A history of whiplash trauma
Major depression or psychiatric illness (diagnosed by a psychiatrist and being in medicamental or psychiatric treatment)
Life threatening, metabolic, cardiovascular, neurologic, systemic diseases
Diagnosis of fibromyalgia/chronic fatigue syndrome
Pregnancy or given birth in the preceding year
Dyslexia, dyscalculia, AD(H)D, language/communication disorder
Chronic subjective tinnitus without chronic pain (additional exclusion criteria)
No history of chronic pain
No pain condition in the last 6 months for which treatment was sought
Healthy controls
No pain in any region > 2/10 on the testing day
Ever experienced whiplash trauma or other form of trauma to the head, neck, or upper quadrant
Specific causes of neck pain, such as cervical hernias with clinical symptoms
Major depression or psychiatric illness (diagnosed by a psychiatrist and being in medicamental or psychiatric treatment)
Life threatening, metabolic, cardiovascular, neurologic, systemic diseases
Diagnosis of fibromyalgia/chronic fatigue syndrome
A history of neck, head or shoulder girdle surgery
A history of whiplash trauma
Pregnancy or given birth in the preceding year
Diagnosis of any TMD, according to the Research Diagnostic Criteria for TMD (RDC/TMD); or concomitant diagnosis of primary headache
Any form of tinnitus and/or hyperacusis
Experiencing any type of pain during at least 8 consecutive days with an NRS higher than 2/10 in the preceding year
Reported pain on the day of testing (VAS higher than 2/10)
Vertigo (Menière's disease, BPPV,…)
Deafness
History of head, neck or shoulder trauma or surgery (< 5 years, or remaining complaints)
Wearing a hearing aid device, implant, noise generators or receiving neuromodulation therapy
Intracranial pathologies
History of head, neck or shoulder trauma or surgery (< 5 years, currently no complaints)
Major depression or psychiatric illness (diagnosed by a psychiatrist and being in medicamental or psychiatric treatment)
Life threatening, metabolic, cardiovascular, neurologic, systemic diseases
A history of whiplash trauma
Diagnosis of fibromyalgia/chronic fatigue syndrome
Pregnancy or given birth in the preceding year
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