Modulating Mechanisms in Patients With Chronic Subjective Tinnitus and/or Chronic Pain (NCT05186259) | Clinical Trial Compass
CompletedNot Applicable
Modulating Mechanisms in Patients With Chronic Subjective Tinnitus and/or Chronic Pain
Belgium135 participantsStarted 2021-12-21
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* …
What they're measuring
1
Between-group differences in mechanical pain sensitivity by means of pressure detection and pain thresholds (expressed in kgf)