Modulating Mechanisms in Patients With Chronic Subjective Tinnitus and/or Chronic Pain
NCT ID: NCT05186259
Last Updated: 2024-01-09
Study Results
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Basic Information
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COMPLETED
NA
135 participants
INTERVENTIONAL
2021-12-21
2022-04-01
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Patients with chronic tinnitus
Patients with chronic subjective tinnitus (\> 3 months)
Self-reported signs of central sensitization
Self-reported signs of central sensitization by means of the Central Sensitization Inventory (questionnaire)
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)
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. .
Cognitive functioning
Evaluation of cognitive functioning by means of:
* Auditory Stroop test
* Detecting letters task
* Letter-number sequencing task
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) .
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
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
Self-reported quality of life
Self-reported quality of life by means of the SF-36 questionnaire
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
Self-reported hyperacusis
Evaluation of self-reported characteristics of hyperacusis by means of the Hyperacusis Questionnaire
Self-reported tinnitus characteristics
Evaluation of self-reported tinnitus characteristics by means of the Tinnitus Sample Case History Questionnaire
Patients with chronic idiopathic neck pain
Patients with chronic idiopathic neck pain (\> 3 months)
Self-reported signs of central sensitization
Self-reported signs of central sensitization by means of the Central Sensitization Inventory (questionnaire)
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)
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
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
Self-reported measure of pain processing
Evaluation of self-reported pain processing by means of the Pain Catastrophizing Scale
Self-reported quality of life
Self-reported quality of life by means of the SF-36 questionnaire
Self reported neck pain related disability
Evaluation of self-reported neck pain related disability using the Neck Disability Index
Patients with chronic tinnitus and chronic musculoskeletal pain
Patients with chronic tinnitus and chronic musculoskeletal pain (\> 3 months)
Self-reported signs of central sensitization
Self-reported signs of central sensitization by means of the Central Sensitization Inventory (questionnaire)
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)
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. .
Cognitive functioning
Evaluation of cognitive functioning by means of:
* Auditory Stroop test
* Detecting letters task
* Letter-number sequencing task
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) .
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
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
Self-reported measure of pain processing
Evaluation of self-reported pain processing by means of the Pain Catastrophizing Scale
Self-reported quality of life
Self-reported quality of life by means of the SF-36 questionnaire
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
Self-reported hyperacusis
Evaluation of self-reported characteristics of hyperacusis by means of the Hyperacusis Questionnaire
Self-reported tinnitus characteristics
Evaluation of self-reported tinnitus characteristics by means of the Tinnitus Sample Case History Questionnaire
Self reported neck pain related disability
Evaluation of self-reported neck pain related disability using the Neck Disability Index
Healthy controls
Healthy controls without tinnitus or pain complaints
Self-reported signs of central sensitization
Self-reported signs of central sensitization by means of the Central Sensitization Inventory (questionnaire)
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)
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
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
Self-reported quality of life
Self-reported quality of life by means of the SF-36 questionnaire
Interventions
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Self-reported signs of central sensitization
Self-reported signs of central sensitization by means of the Central Sensitization Inventory (questionnaire)
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)
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. .
Cognitive functioning
Evaluation of cognitive functioning by means of:
* Auditory Stroop test
* Detecting letters task
* Letter-number sequencing task
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) .
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
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
Self-reported measure of pain processing
Evaluation of self-reported pain processing by means of the Pain Catastrophizing Scale
Self-reported quality of life
Self-reported quality of life by means of the SF-36 questionnaire
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
Self-reported hyperacusis
Evaluation of self-reported characteristics of hyperacusis by means of the Hyperacusis Questionnaire
Self-reported tinnitus characteristics
Evaluation of self-reported tinnitus characteristics by means of the Tinnitus Sample Case History Questionnaire
Self reported neck pain related disability
Evaluation of self-reported neck pain related disability using the Neck Disability Index
Eligibility Criteria
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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 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)
* Chronic ideopathic neck pain:
* Aged between 18-65 years
* 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)
* Healthy controls:
* Aged between 18-65 years
Exclusion Criteria
* 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
* 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
* No history of chronic pain
* No pain condition in the last 6 months for which treatment was sought
* No pain in any region \> 2/10 on the testing day
* Chronic ideopathic neck pain:
* 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
* Healthy controls:
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Bijzonder onderzoeksfonds (BOF)
UNKNOWN
University Ghent
OTHER
Responsible Party
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Locations
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Ghent University
Ghent, Oost-Vlaanderen, Belgium
Countries
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References
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De Meulemeester K, Meeus M, De Pauw R, Cagnie B, Keppler H, Lenoir D. Suffering from chronic tinnitus, chronic neck pain, or both: Does it impact the presence of signs and symptoms of central sensitization? PLoS One. 2023 Aug 24;18(8):e0290116. doi: 10.1371/journal.pone.0290116. eCollection 2023.
Other Identifiers
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BC-07036
Identifier Type: -
Identifier Source: org_study_id
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