Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT05186259
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05186259
Study Brief:
Protocol Section:
NCT05186259