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

CompletedNot applicableNCT05186259
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Modulating Mechanisms in Patients With Chronic Subjective Tinnitus and/or Chronic Pain
Conditions
Interventions
  • Diagnostic test: Self-reported signs of central sensitization
  • Diagnostic test: Objective signs of central sensitization
  • Diagnostic test: Audiological outcome measures (audiometry, tinnitus analysis, uncomfortable loudness) in tinnitus patients with and without pain
  • Diagnostic test: Cognitive functioning
  • Diagnostic test: Listening effort
  • Diagnostic test: Self-reported psychological factors
  • Diagnostic test: Self-reported lifestyle factors
  • Diagnostic test: Self-reported measure of pain processing
  • Diagnostic test: Self-reported quality of life
  • Diagnostic test: Self-reported tinnitus severity and impact on daily life
  • Diagnostic test: Self-reported hyperacusis
  • Diagnostic test: Self-reported tinnitus characteristics
  • Diagnostic test: Self reported neck pain related disability
Sponsor
University Ghent
Collaborators
Bijzonder onderzoeksfonds (BOF)
Start date
2021-12-21
Primary completion
2022-04-01
Sex
All
Age range
from 18 Years to 65 Years
Healthy volunteers
true
Results posted
No results posted in this snapshot
Countries
Belgium
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 trea…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05186259