Clinical trial NCT05186259: Modulating Mechanisms in Patients With Chronic Subjective Tinnitus and/or Chronic Pain
Official title: Modulating Mechanisms in Patients With Chronic Subjective Tinnitus and/or Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Pain
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Bijzonder onderzoeksfonds (BOF)
First posted: 2022-01-11
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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)

Eligibility criteria: Inclusion Criteria:

* Chronic subjective tinnitus patients without 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
* 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:

* 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
  * 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
  * 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

Primary outcomes:
measure: Between-group differences in mechanical pain sensitivity by means of pressure detection and pain thresholds (expressed in kgf)
timeFrame: At baseline
Secondary outcomes:
measure: Tinnitus analysis
timeFrame: At baseline
measure: Audiometric assessments
timeFrame: At baseline
measure: Between-group differences in heat pain sensitivity by means of heat detection and pain thresholds (expressed in °)
timeFrame: At baseline
measure: Between-group differences in endogenous pain facilitation by means of a temporal summation protocol (expressed in pain scores (numeric rating scales, NRS)
timeFrame: At baseline
measure: Between-group differences in endogenous pain inhibition by means of conditioned pain modulation protocol (expressed in kgf and °)
timeFrame: At baseline
measure: Between-group differences in self-reported signs of central sensitization by means of the Dutch version of the Central Sensitization Inventory (questionnaire)
timeFrame: At baseline
measure: Between-group differences in self-reported psychological factors
timeFrame: At baseline
measure: Between-group differences in self-reported psychological factors
timeFrame: At baseline
measure: Between-group differences in self-reported psychological factors
timeFrame: At baseline
measure: Between-group differences in self-reported psychological factors
timeFrame: At baseline
measure: Between-group differences in self-reported lifestyle factors
timeFrame: At baseline
measure: Between-group differences in self-reported lifestyle factors
timeFrame: At baseline
measure: Between-group differences in self-reported lifestyle factors
timeFrame: At baseline
measure: Between-group differences in self-reported quality of life
timeFrame: At baseline
measure: Between-group differences in self-reported neck pain related measures
timeFrame: At baseline
measure: Between-group differences in self-reported neck pain related measures
timeFrame: At baseline
measure: Between-group differences in self-reported tinnitus related measures
timeFrame: At baseline
measure: Between-group differences in self-reported tinnitus related measures
timeFrame: At baseline
measure: Between-group differences in self-reported tinnitus related measures
timeFrame: At baseline
measure: Cognitive functioning
timeFrame: At baseline
measure: Cognitive functioning
timeFrame: At baseline
measure: Cognitive functioning
timeFrame: At baseline
measure: Cognitive functioning
timeFrame: At baseline
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Ghent University
state: Oost-Vlaanderen
Study officials:
References: