Modulating Mechanisms in Patients With Chronic Subjective Tinnitus and/or Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Between-group differences in mechanical pain sensitivity by means of pressure detection and pain thresholds (expressed in kgf)
研究概览
简要总结
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.
详细描述
The first aim is to investigate differences in pain-related factors, psychological factors, lifestyle factors and tinnitus-related factors in patients with chronic subjective tinnitus and the comparison with patients suffering from both chronic subjective tinnitus and chronic musculoskeletal pain, chronic musculoskeletal pain only and healthy controls. The primary outcome measures will be pain-related factors and correlations will also be calculated between pain-related factors on the one hand and psychological factors, lifestyle factors and tinnitus-related factors on the other hand.
A second aim is to assess contributing factors to tinnitus severity (measured by the Tinnitus Functional Index) in patients with tinnitus with or without chronic pain. Contributing factors will include pain-related factors, psychological factors, lifestyle factors, and tinnitus-related factors, audiological factors, cognitive factors.
- Pain-related factors include:
- Self-perceived symptoms of central sensitization by means of the Central Sensitization Inventory: The Central Sensitization Inventory is a self-report questionnaire that assesses clinical symptoms indicative for central sensitization.
- Experimental 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.
- Self-reported pain processing by means of the Pain Catastrophizing Scale
- Self-reported neck pain related disability by means of the Neck Disability Index
- Psychological factors include:
Self-reported stress, anxiety and depression (Depression, Anxiety and Stress Scale_21 and Beck Depression Inventory), resilience (Connor Davidson Resilience Scale), personality (Big Five Index)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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,...)
- •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,...)
- •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
研究组 & 干预措施
Patients with chronic idiopathic neck pain
Patients with chronic idiopathic neck pain (> 3 months)
干预措施: Self-reported signs of central sensitization (Diagnostic Test)
Patients with chronic tinnitus
Patients with chronic subjective tinnitus (> 3 months)
干预措施: Self-reported tinnitus characteristics (Diagnostic Test)
Patients with chronic tinnitus
Patients with chronic subjective tinnitus (> 3 months)
干预措施: Self-reported signs of central sensitization (Diagnostic Test)
Patients with chronic tinnitus
Patients with chronic subjective tinnitus (> 3 months)
干预措施: Objective signs of central sensitization (Diagnostic Test)
Patients with chronic tinnitus
Patients with chronic subjective tinnitus (> 3 months)
干预措施: Audiological outcome measures (audiometry, tinnitus analysis, uncomfortable loudness) in tinnitus patients with and without pain (Diagnostic Test)
Patients with chronic tinnitus
Patients with chronic subjective tinnitus (> 3 months)
干预措施: Cognitive functioning (Diagnostic Test)
Patients with chronic tinnitus
Patients with chronic subjective tinnitus (> 3 months)
干预措施: Listening effort (Diagnostic Test)
Patients with chronic tinnitus
Patients with chronic subjective tinnitus (> 3 months)
干预措施: Self-reported psychological factors (Diagnostic Test)
Patients with chronic tinnitus
Patients with chronic subjective tinnitus (> 3 months)
干预措施: Self-reported lifestyle factors (Diagnostic Test)
Patients with chronic tinnitus
Patients with chronic subjective tinnitus (> 3 months)
干预措施: Self-reported quality of life (Diagnostic Test)
Patients with chronic tinnitus
Patients with chronic subjective tinnitus (> 3 months)
干预措施: Self-reported tinnitus severity and impact on daily life (Diagnostic Test)
Patients with chronic tinnitus
Patients with chronic subjective tinnitus (> 3 months)
干预措施: Self-reported hyperacusis (Diagnostic Test)
Patients with chronic idiopathic neck pain
Patients with chronic idiopathic neck pain (> 3 months)
干预措施: Objective signs of central sensitization (Diagnostic Test)
Patients with chronic idiopathic neck pain
Patients with chronic idiopathic neck pain (> 3 months)
干预措施: Self-reported psychological factors (Diagnostic Test)
Patients with chronic idiopathic neck pain
Patients with chronic idiopathic neck pain (> 3 months)
干预措施: Self-reported lifestyle factors (Diagnostic Test)
Patients with chronic idiopathic neck pain
Patients with chronic idiopathic neck pain (> 3 months)
干预措施: Self-reported measure of pain processing (Diagnostic Test)
Patients with chronic idiopathic neck pain
Patients with chronic idiopathic neck pain (> 3 months)
干预措施: Self-reported quality of life (Diagnostic Test)
Patients with chronic idiopathic neck pain
Patients with chronic idiopathic neck pain (> 3 months)
干预措施: Self reported neck pain related disability (Diagnostic Test)
Patients with chronic tinnitus and chronic musculoskeletal pain
Patients with chronic tinnitus and chronic musculoskeletal pain (> 3 months)
干预措施: Self-reported signs of central sensitization (Diagnostic Test)
Patients with chronic tinnitus and chronic musculoskeletal pain
Patients with chronic tinnitus and chronic musculoskeletal pain (> 3 months)
干预措施: Objective signs of central sensitization (Diagnostic Test)
Patients with chronic tinnitus and chronic musculoskeletal pain
Patients with chronic tinnitus and chronic musculoskeletal pain (> 3 months)
干预措施: Audiological outcome measures (audiometry, tinnitus analysis, uncomfortable loudness) in tinnitus patients with and without pain (Diagnostic Test)
Patients with chronic tinnitus and chronic musculoskeletal pain
Patients with chronic tinnitus and chronic musculoskeletal pain (> 3 months)
干预措施: Cognitive functioning (Diagnostic Test)
Patients with chronic tinnitus and chronic musculoskeletal pain
Patients with chronic tinnitus and chronic musculoskeletal pain (> 3 months)
干预措施: Listening effort (Diagnostic Test)
Patients with chronic tinnitus and chronic musculoskeletal pain
Patients with chronic tinnitus and chronic musculoskeletal pain (> 3 months)
干预措施: Self-reported psychological factors (Diagnostic Test)
Patients with chronic tinnitus and chronic musculoskeletal pain
Patients with chronic tinnitus and chronic musculoskeletal pain (> 3 months)
干预措施: Self-reported lifestyle factors (Diagnostic Test)
Patients with chronic tinnitus and chronic musculoskeletal pain
Patients with chronic tinnitus and chronic musculoskeletal pain (> 3 months)
干预措施: Self-reported measure of pain processing (Diagnostic Test)
Patients with chronic tinnitus and chronic musculoskeletal pain
Patients with chronic tinnitus and chronic musculoskeletal pain (> 3 months)
干预措施: Self-reported quality of life (Diagnostic Test)
Patients with chronic tinnitus and chronic musculoskeletal pain
Patients with chronic tinnitus and chronic musculoskeletal pain (> 3 months)
干预措施: Self-reported tinnitus severity and impact on daily life (Diagnostic Test)
Patients with chronic tinnitus and chronic musculoskeletal pain
Patients with chronic tinnitus and chronic musculoskeletal pain (> 3 months)
干预措施: Self-reported hyperacusis (Diagnostic Test)
Patients with chronic tinnitus and chronic musculoskeletal pain
Patients with chronic tinnitus and chronic musculoskeletal pain (> 3 months)
干预措施: Self-reported tinnitus characteristics (Diagnostic Test)
Patients with chronic tinnitus and chronic musculoskeletal pain
Patients with chronic tinnitus and chronic musculoskeletal pain (> 3 months)
干预措施: Self reported neck pain related disability (Diagnostic Test)
Healthy controls
Healthy controls without tinnitus or pain complaints
干预措施: Self-reported signs of central sensitization (Diagnostic Test)
Healthy controls
Healthy controls without tinnitus or pain complaints
干预措施: Objective signs of central sensitization (Diagnostic Test)
Healthy controls
Healthy controls without tinnitus or pain complaints
干预措施: Self-reported psychological factors (Diagnostic Test)
Healthy controls
Healthy controls without tinnitus or pain complaints
干预措施: Self-reported lifestyle factors (Diagnostic Test)
Healthy controls
Healthy controls without tinnitus or pain complaints
干预措施: Self-reported quality of life (Diagnostic Test)
结局指标
主要结局
Between-group differences in mechanical pain sensitivity by means of pressure detection and pain thresholds (expressed in kgf)
时间窗: 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
次要结局
- Between-group differences in self-reported quality of life(At baseline)
- Between-group differences in self-reported psychological factors(At baseline)
- Between-group differences in self-reported lifestyle factors(At baseline)
- Between-group differences in self-reported neck pain related measures(At baseline)
- Between-group differences in self-reported tinnitus related measures(At baseline)
- Cognitive functioning(At baseline)
- 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 self-reported signs of central sensitization by means of the Dutch version of the Central Sensitization Inventory (questionnaire)(At baseline)
- Between-group differences in endogenous pain inhibition by means of conditioned pain modulation protocol (expressed in kgf and °)(At baseline)