Modulating Mechanisms in Patients With Chronic Subjective Tinnitus and/or Chronic Pain
1 other identifier
interventional
135
1 country
1
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 tinnitus without chronic pain, chronic pain without tinnitus and healthy controls.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2021
CompletedStudy Start
First participant enrolled
December 21, 2021
CompletedFirst Posted
Study publicly available on registry
January 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedJanuary 9, 2024
January 1, 2024
3 months
November 24, 2021
January 8, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Between-group differences in mechanical pain sensitivity by means of pressure detection and pain thresholds (expressed in kgf)
Pain sensitivity will be assessed by a mechanical stimulus, which is given by the tester with a digital pressure algometer (FDX; Wagner Instruments) at a rate of 1 kg pressure rise per second. The participant is asked to say 'yes' if the point was reached when the pressure stimulus causes a sensation of pain (detection threshold), the tester continues giving pressure until the patient says 'yes' for a second time indicating the feeling of pain reached a 6/10 of the NRS (pain threshold). T Two consecutive measurements with a break of 30 seconds are performed. This protocol is performed at 5 standardized body locations, being: C5-C cervical joint, N. Trigeminus, M. Masseter, M. Extensor carpi radialis longus, M. Tibialis Anterior
At baseline
Secondary Outcomes (23)
Tinnitus analysis
At baseline
Audiometric assessments
At baseline
Between-group differences in heat pain sensitivity by means of heat detection and pain thresholds (expressed in °)
At baseline
Between-group differences in endogenous pain facilitation by means of a temporal summation protocol (expressed in pain scores (numeric rating scales, NRS)
At baseline
Between-group differences in endogenous pain inhibition by means of conditioned pain modulation protocol (expressed in kgf and °)
At baseline
- +18 more secondary outcomes
Study Arms (4)
Patients with chronic tinnitus
ACTIVE COMPARATORPatients with chronic subjective tinnitus (\> 3 months)
Patients with chronic idiopathic neck pain
ACTIVE COMPARATORPatients with chronic idiopathic neck pain (\> 3 months)
Patients with chronic tinnitus and chronic musculoskeletal pain
ACTIVE COMPARATORPatients with chronic tinnitus and chronic musculoskeletal pain (\> 3 months)
Healthy controls
ACTIVE COMPARATORHealthy controls without tinnitus or pain complaints
Interventions
Self-reported signs of central sensitization by means of the Central Sensitization Inventory (questionnaire)
Objective signs of central sensitization by means of Quantitative Sensory Testing (mechanical and heat detection and pain thresholds, endogenous pain facilitation and inhibition)
* Audiometry Performance of pure tone audiometry according to the modified Hughson-Westlake method * Tinnitus analysis Measurement of psychoacoustic features of tinnitus, including (1) tinnitus pitch, (2) loudness, (3) masking ability, and (4) residual inhibition. * Uncomfortable Loudness measures Performance of Uncomfortable Loudness measurements to evaluate the presence of hyperacusis. .
Evaluation of cognitive functioning by means of: * Auditory Stroop test * Detecting letters task * Letter-number sequencing task
Evaluation of listening effort by means of the modified version of the behavioral listening effort test based on a dual-task paradigm by Degeest, Keppler \& Corthals (2018) .
Evaluation of psychological factors by means of: * Depression, Anxiety and Stress Scale (DASS-21) * Beck Depression Inventory (BDI) * Big Five Inventory (BFI) * Connor-Davidson Resilience Scale
Evaluation of lifestyle factors by means of: Baecke Questionnaire Pittsburg Sleep Quality Index Insomnia Severity Index Stress subscale of the DASS 21
Evaluation of self-reported pain processing by means of the Pain Catastrophizing Scale
Self-reported quality of life by means of the SF-36 questionnaire
Evaluation of self-reported tinnitus severity and impact on daily life by means of the Tinnitus Functional Index
Evaluation of self-reported characteristics of hyperacusis by means of the Hyperacusis Questionnaire
Evaluation of self-reported tinnitus characteristics by means of the Tinnitus Sample Case History Questionnaire
Evaluation of self-reported neck pain related disability using the Neck Disability Index
Eligibility Criteria
You may qualify if:
- 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:
- +1 more criteria
You may not qualify if:
- 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
- +28 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Ghentlead
- Bijzonder onderzoeksfonds (BOF)collaborator
Study Sites (1)
Ghent University
Ghent, Oost-Vlaanderen, 9000, Belgium
Related Publications (1)
De Meulemeester K, Meeus M, De Pauw R, Cagnie B, Keppler H, Lenoir D. Suffering from chronic tinnitus, chronic neck pain, or both: Does it impact the presence of signs and symptoms of central sensitization? PLoS One. 2023 Aug 24;18(8):e0290116. doi: 10.1371/journal.pone.0290116. eCollection 2023.
PMID: 37616265DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2021
First Posted
January 11, 2022
Study Start
December 21, 2021
Primary Completion
April 1, 2022
Study Completion
April 1, 2022
Last Updated
January 9, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share