Modulating Mechanisms in Patients With Chronic Subjective Tinnitus and/or Chronic Pain
NCT05186259, Not applicable, Completed, University Ghent
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Modulating Mechanisms in Patients With Chronic Subjective Tinnitus and/or Chronic Pain | ClinicalTrials.gov |
| NCT number | NCT05186259 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 135 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University Ghent | ClinicalTrials.gov |
| Conditions | Tinnitus, Pain | ClinicalTrials.gov |
| Interventions | Self-reported signs of central sensitization, Objective signs of central sensitization, Audiological outcome measures (audiometry, tinnitus analysis, uncomfortable loudness) in tinnitus patients with and without pain, Cognitive functioning, Listening effort, Self-reported psychological factors, Self-reported lifestyle factors, Self-reported measure of pain processing, Self-reported quality of life, Self-reported tinnitus severity and impact on daily life, Self-reported hyperacusis, Self-reported tinnitus characteristics, Self reported neck pain related disability | ClinicalTrials.gov |
| First posted | 2022-01-11 | ClinicalTrials.gov |
| Last updated | 2024-01-09 | ClinicalTrials.gov |
Registered outcomes 24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Between-group differences in mechanical pain sensitivity by means of pressure detection and pain thresholds (expressed in kgf) | At baseline | 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 | ClinicalTrials.gov |
| Secondary | Tinnitus analysis | At baseline | Tinnitus analysis Psychoacoustic features of tinnitus will be determined using the same equipment that was used for pure tone audiometry. The tinnitus analysis included determining. | ClinicalTrials.gov |
| Secondary | Audiometric assessments | At baseline | Audiometry Pure tone audiometry according to the modified Hughson-Westlake method will be performed. For air conduction, pure tone thresholds will be determined at octave frequencies from 0.25 to 8 kHz and at half-octave frequencies 3 and 6 kHz (DD45 audiometric headset, Calisto audiometer, Interacoustics). For each ear separately, hearing thresholds (using tonal luminal audiometry) and uncomfortable loudness (UCL) levels were determined on all octave frequencies between 250 and 8000 Hertz (Hz). Based on the audiometric thresholds and UCL levels, the Johnson Hyperacusis Quotient. | ClinicalTrials.gov |
| Secondary | Between-group differences in heat pain sensitivity by means of heat detection and pain thresholds (expressed in °) | At baseline | Heat stimuli are given using the CHEPS PATHWAY system (Medoc). This probe is placed on the skin at the 5 standardized locations. It provides a heat stimulus that rises at a rate of 1°C/second. Using a dual response button, the participant has to indicate when the heat sensation changes into a pain sensation by pressing a blue button (detection threshold). The temperature keeps rising after the blue button is pressed. If the patient scores the pain sensation resulting from the heat stimulus as a 6/10 on the NRS they have to press the red button. At that moment, the temperature of the thermode goes back to the baseline temperature of 32°C. When the baseline temperature is reached, a second heat stimulus is given after a 15 second break. 3 consecutive trials will be 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 | ClinicalTrials.gov |
| Secondary | Between-group differences in endogenous pain facilitation by means of a temporal summation protocol (expressed in pain scores (numeric rating scales, NRS) | At baseline | Temporal Summation is performed with the Contact Heat-Evoked Potential Stimulator (CHEPS) model. Temporal summation is evaluated at the M. tibialis anterior and the M. extensor carpi radialis longus. The temperature corresponding with the mean score of the 6/10 NRS score (heat pain threshold) from the corresponding body part is used as the painful stimulus. Ten stimuli from the same heat are given to the participant with a thermode. After stimulus 1, 5 and 10 a beep sound is heard. At these moments the participant has to score the pain that they experience from the previous stimulus on the NRS from 0 to 10. Between stimuli the temperature goes back to the baseline temperature of 32°C. The velocity of the heating is 70°C/second and the velocity of the cooling down is 40°/second. Each stimulus is 0.5 seconds long with a frequency of 0.5 Hz. | ClinicalTrials.gov |
| Secondary | Between-group differences in endogenous pain inhibition by means of conditioned pain modulation protocol (expressed in kgf and °) | At baseline | Conditioned pain modulation is tested by asking the participant to put their non- non-dominant or non-painful dominant hand (up to the wrist joint) in a water bath of 45,5°C for 1 minute. This is the conditioning stimulus. After this, a PPT measurement is performed to measure pressure detection and pain thresholds again, at the level of the M. extensor carpi radialis longus. Two consecutive measurements of the PPTs are being performed with a 30 seconds interval in between. Thereafter, the non-dominant or non-painful hand is placed in the hot water for another minute and after this minute, heat detection and pain thresholds are evaluated again at the M. extensor carpi radialis longus. Both pressure and heat are the testing stimulus. Also, the NRS score (0-10) for the water was asked to know if they perceived the water as a high enough pain stimulus. | ClinicalTrials.gov |
| Secondary | Between-group differences in self-reported signs of central sensitization by means of the Dutch version of the Central Sensitization Inventory (questionnaire) | At baseline | The Central Sensitization Inventory measures the somatic and emotional symptoms commonly associated with central sensitization. It consists of two parts, one measuring 25 symptoms, the other asks whether patients have been previously diagnosed with ten specific diagnoses. A cut off of 40 out of 100 is used to determine the presence of self-reported signs of central sensitization (the higher the score, the higher the severity). | ClinicalTrials.gov |
| Secondary | Between-group differences in self-reported psychological factors | At baseline | Three negative emotional dimensions: 'depression', 'anxiety' and 'stress were evaluated using the self-report Depression Anxiety and Stress Scale 21 (DASS21), which is a short version of the DASS.The total score ranges between 0 and 126 and higher scores indicate more severe negative emotional status. | ClinicalTrials.gov |
| Secondary | Between-group differences in self-reported psychological factors | At baseline | The Dutch version of the Beck Depression Inventory (BDI) was used for the assessment of depression. The total score of the BDI ranges between 0 and 63 and higher scores reflect more severe depression. | ClinicalTrials.gov |
| Secondary | Between-group differences in self-reported psychological factors | At baseline | The Dutch version of the Connor-Davidson Resilience Scale 25 (CD-RISC 25) was used to assess resilience, which is a measure of stress coping ability. The total score ranges between 0 and 100 and a higher score reflects greater resilience. | ClinicalTrials.gov |
| Secondary | Between-group differences in self-reported psychological factors | At baseline | The Big Five Index 2 (BFI-2) was used to quantify five traits of personality, namely agreeableness, conscientiousness, extraversion, neuroticism, and openness. The BFI-2 consists of 15 facets, describing different features of each trait | ClinicalTrials.gov |
| Secondary | Between-group differences in self-reported lifestyle factors | At baseline | Self-reported physical activity levels were evaluated using the Baecke Physical Activity Questionnaire. This questionnaire consists of 16 items assessing three different domains of physical activity: work, sports and leisure time. The total score varies between 3 and 15 with a higher score reflecting a greater level of physical activity. | ClinicalTrials.gov |
| Secondary | Between-group differences in self-reported lifestyle factors | At baseline | The Pittsburgh Sleep Quality Index (PSQI) was used to evaluate self-perceived overall sleep quality in 7 domains: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, sleep medication, and daytime dysfunction over the previous month. The maximal score ranges between 0 and 21, and a global score of 5 or higher indicates clinically significant sleep problems | ClinicalTrials.gov |
| Secondary | Between-group differences in self-reported lifestyle factors | At baseline | The Insomnia Severity Index (ISI) was used to assess the patient's perception of insomnia severity. The ISI consists of seven items assessing the severity of sleep onset and sleep maintenance difficulties (both nocturnal and early morning awakenings), satisfaction with current sleep pattern, interference with daily functioning, notice ability of impairment attributed to the sleep problem and degree of distress or concern caused by the sleep problem. The maximal score ranges between 0 and 28 and higher scores indicate more severe insomnia. | ClinicalTrials.gov |
| Secondary | Between-group differences in self-reported quality of life | At baseline | Self-reported health-related quality of life will be evaluated using the SF- 36. This self-report questionnaire consists of 36 items that can be clustered into eight subscales: physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. The summation of all subscales provides the total score (0-800). | ClinicalTrials.gov |
| Secondary | Between-group differences in self-reported neck pain related measures | At baseline | The Dutch version of the Neck Disability Index (NDI) will be used to evaluate the level of self-reported pain-related disability. The NDI consists of 10 items and has a total score of 50. Higher NDI scores reflect higher levels of neck pain-related disability. A score between 0 and 4 reflects no disability, a score between 5 and 14 indicates mild disability, between 15 and 24 moderate disability, between 25 and 34 severe disability and \> 35 is considered as complete disability. ( | ClinicalTrials.gov |
| Secondary | Between-group differences in self-reported neck pain related measures | At baseline | Neck pain catastrophizing will be assessed using the Dutch Pain Catastrophizing Scale (PCS), which is a self-report questionnaire to evaluate the presence of catastrophic thoughts and feelings towards pain. The PCS consists of 13 items and has a maximal score of 52. Higher scores indicate higher levels of pain catastrophizing. The PCS includes three subscales; magnification (experiencing pain as a threat), rumination (repeated worrying), and helplessness (believing that nothing can resolve the pain). | ClinicalTrials.gov |
| Secondary | Between-group differences in self-reported tinnitus related measures | At baseline | The Dutch validated version of the Tinnitus Sample Case History Questionnaire (TSCHQ) will be used for the standardized collection of information regarding the tinnitus history, tinnitus characteristics, modulating factors and other symptoms such as neck pain or headache. | ClinicalTrials.gov |
| Secondary | Between-group differences in self-reported tinnitus related measures | At baseline | The Dutch validated version of the Tinnitus Functional Index (TFI) will be used to evaluate tinnitus impact. The TFI is a 25-item self-report questionnaire with a total score ranging between 0 and 100, which consists of eight different subscales (intrusiveness, cognition, sleep, sense of control, relaxation, emotional, auditory and quality of life subscales). The higher the score, the higher the tinnitus impact. | ClinicalTrials.gov |
| Secondary | Between-group differences in self-reported tinnitus related measures | At baseline | The Dutch version of the Hyperacusis Questionnaire (HQ) will be used for the quantification and characterization of hyperacusis. The HQ consists of 14 items with a total score ranging between 0 and 42, a score greater than 28 is considered to represent auditory hypersensitivity or hyperacusis. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 37616265 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Letter-Number Sequencing Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)