Status:
COMPLETED
Modulating Mechanisms in Patients With Chronic Subjective Tinnitus and/or Chronic Pain
Lead Sponsor:
University Ghent
Collaborating Sponsors:
Bijzonder onderzoeksfonds (BOF)
Conditions:
Tinnitus
Pain
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
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 comparis...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2022
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT05186259
Start Date
December 21 2021
End Date
April 1 2022
Last Update
January 9 2024
Active Locations (1)
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1
Ghent University
Ghent, Oost-Vlaanderen, Belgium, 9000