Modulating Mechanisms in Patients With Chronic Subjective Tinnitus and/or Chronic Pain
CompletedNot applicableNCT05186259
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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
- Tinnitus
- Pain
- 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