Modulating Mechanisms in Patients With Chronic Subjective Tinnitus and/or Chronic Pain
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
The aim is to investigate differences in signs of central sensitization in patients with chronic subjective tinnitus and the comparison with patients suffering from both chronic subjective tinnitus and chronic musculoskeletal pain, chronic musculoskeletal pain alone and healthy controls.
It can be hypothesized that central sensitization is higher in patients with chronic pain and in patients with chronic tinnitus, compared to healthy controls. Central sensitization is expected to be most present in patients with both chronic subjective tinnitus and chronic pain.
Assessments of patients suffering from chronic tinnitus alone, chronic tinnitus combined with chronic pain, chronic neck pain patients without tinnitus & healthy controls:
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Clinical measure of central sensitization: Self-perceived symptoms of central sensitization The central sensitization inventory is a self-report questionnaire that assesses clinical symptoms indicative for central sensitization.
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Objective measures of central sensitization: Quantitative Sensory Testing Quantitative Sensory Testing (QST) is a psychophysiological assessment of sensory pathways including mechanicaldetection and pain thresholds, cutaneous heat detection and pain thresholds, and endogenous pain facilitation and inhibition.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Patients with chronic tinnitus Patients with chronic subjective tinnitus (> 3 months) |
Diagnostic Test: Self-reported signs of central sensitization
Self-reported signs of central sensitization by means of the Central Sensitization Inventory (questionnaire)
Diagnostic Test: Objective signs of central sensitization
Objective signs of central sensitization by means of Quantitative Sensory Testing (mechanical and heat detection and pain thresholds, endogenous pain facilitation and inhibition)
|
| Active Comparator: Patients with chronic idiopathic neck pain Patients with chronic idiopathic neck pain (> 3 months) |
Diagnostic Test: Self-reported signs of central sensitization
Self-reported signs of central sensitization by means of the Central Sensitization Inventory (questionnaire)
Diagnostic Test: Objective signs of central sensitization
Objective signs of central sensitization by means of Quantitative Sensory Testing (mechanical and heat detection and pain thresholds, endogenous pain facilitation and inhibition)
|
| Active Comparator: Patients with chronic tinnitus and chronic neck pain Patients with chronic tinnitus and chronic neck pain (> 3 months) |
Diagnostic Test: Self-reported signs of central sensitization
Self-reported signs of central sensitization by means of the Central Sensitization Inventory (questionnaire)
Diagnostic Test: Objective signs of central sensitization
Objective signs of central sensitization by means of Quantitative Sensory Testing (mechanical and heat detection and pain thresholds, endogenous pain facilitation and inhibition)
|
| Active Comparator: Healthy controls Healthy controls without tinnitus or pain complaints |
Diagnostic Test: Self-reported signs of central sensitization
Self-reported signs of central sensitization by means of the Central Sensitization Inventory (questionnaire)
Diagnostic Test: Objective signs of central sensitization
Objective signs of central sensitization by means of Quantitative Sensory Testing (mechanical and heat detection and pain thresholds, endogenous pain facilitation and inhibition)
|
Outcome Measures
Primary Outcome Measures
- 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
Secondary Outcome Measures
- 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
- 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.
- 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.
- 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
Chronic subjective tinnitus patients without chronic pain:
Aged between 18-65 years Subjective non-pulsatile tinnitus > 6 months Stable, non-fluctuating tinnitus in the past 6 months Modifiable character tinnitus Native Dutch speaker
Chronic subjective tinnitus patients without chronic pain:
Additionaly: musculoskeletal pain > 3 months
Chronic ideopathic neck pain:
Adult population (18-65 years old) 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) Mild/moderate to severe pain-related disability, established by a score of 5 or more of a maximum of 50 on the Neck Disability Index (NDI)
Healthy controls:
Adult population (18-65 years old)
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 History of head, neck or shoulder trauma or surgery Major depression or psychiatric illness (diagnosed by a psychiatrist and being in medicamental or psychiatric treatment) Life threatening, metabolic, cardiovascular, neurologic, systemic diseases Pregnancy or given birth in the preceding year
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 Presence of major depression or psychiatric illness ("diagnosed psychiatric disorder") Diagnosis of a neurologic, metabolic, or cardiovascular disorders; malignancy, inflammatory conditions; fibromyalgia; chronic fatigue syndrome, musculoskeletal disorder A history of neck, head or shoulder girdle surgery Women who are pregnant and women who are 1 year postnatal Presence of severe degenerative arthritis (confirmed by cervical radiography taken for all patients over the age of 30 years); diagnosis of any TMD, according to the Research Diagnostic Criteria for TMD (RDC/TMD); or concomitant diagnosis of primary headache
Healthy controls:
Additionaly: 1) presence of tinnitus complaints, 2) a history of chronic pain, 3) a pain condition in the last 6 months for which treatment was sought, 4) neck pain during at least 8 consecutive days with a minimal intensity of 2/10 on a visual analogue scale
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ghent University | Gent | Oost-Vlaanderen | Belgium | 9000 |
Sponsors and Collaborators
- University Ghent
- Bijzonder onderzoeksfonds (BOF)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BC-07036