Pain In Neuropathy Study
试验速览
- 阶段
- 不适用
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Diagnosis of neuropathy
研究概览
简要总结
In the context of peripheral neuropathy, we will aim to elucidate correlates between sensory symptoms and:
- Sensory nerve dysfunction.
- Cutaneous small nerve fibre innervation density.
- Psychological co-morbidity.
- Circadian rhythm disturbance co-morbidity.
- Functionality and Quality of life.
- Patterns of human brain activity in a subset of patients that consent to participate in the FMRI (functional magnetic resonance imaging) component of PINS.
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We will also collect blood samples in this phenotyped cohort of patients. These blood samples coupled with detailed phenotype data will investigate potential gene associations only in the development of painful neuropathy.
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Knowledge gained from the study will be used to aid the further development of pain questionnaires, designed to detect patients with painful neuropathy.
4.Knowledge gained from the study will be invaluable in informing on-going investigations of painful peripheral neuropathy in animal models, both in our laboratory and others.
详细描述
Very little is currently known about why some patients with peripheral neuropathy develop neuropathic pain, whilst others do not. It is anticipated that this study will begin to identify features of the peripheral neuropathy, which are and are not, associated with the development and intensity of neuropathic pain and therefore begin to elucidate factors, which underlie pain. We will also compare findings in neuropathies resulting from diverse aetiologies including diabetes, HIV and idiopathic axonal neuropathies in order to investigate, whether there are differences in pain symptomatology, NCS, QST, patterns of evoked brain activity and small fibre dysfunction in these different contexts.
We would like to answer the following question:
'In patients suffering from peripheral neuropathy what are the relationships between pain symptomatology and peripheral sensory dysfunction, intraepidermal nerve fibre density (IENFD) and psychological, and circadian rhythm co-morbidity as well as in everyday functionality?
1.2.1 Quantitative sensory testing (QST) and neuropathic pain.
Nerve conduction studies (NCS) predominantly assess large fibre function and indeed in the context of small fibre neuropathy are often normal. We propose to assess the utility of two relatively non-invasive tools, which are routinely used, both in our practice and elsewhere, to assess small fibre dysfunction: quantitative sensory testing (QST) and intraepidermal nerve fibre density (IENFD). There have been studies examining both of these in the context of neuropathy, but the exact relationship of these measures to abnormalities to pain, quality of life and psychological state is largely unknown.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are ≥18 years of age who have a diagnosis of peripheral neuropathy based on a prior clinical assessment combined with supportive clinical investigations such as abnormal nerve conduction studies, reduced intraepidermal nerve or abnormal findings on quantitative sensory testing.
- •If supportive clinical investigations (as described above) are not available at entry into the study a neuropathy disability scale ≥3 (Pham et al., 2000).
- •And patients with symptoms highly suggestive of neuropathy that in the judgement of the clinical researcher are suitable for the study even if they do not fulfill other inclusion criteria.
- •Patients who do not fulfill any of the exclusion criteria.
排除标准
- •Subjects who are pregnant.
- •Subjects with insufficient command of English to obtain consent from or to complete the study questionnaires.
- •Subjects with insufficient mental capacity to obtain consent from or complete study questionnaires.
- •Subjects with concurrent severe psychological or psychiatric disorders.
- •Patients with moderate to severe pain form other causes that may confound assessment or reporting of pain (eg. spinal canal stenosis).
- •Patients with central nervous lesions, which may complicate somatosensory testing.
- •Who is in the opinion of the investigator unsuitable for participation in the study.
- •Skin biopsies will not be conducted on patients that are anticoagulated or who have any other contra-indication to skin biopsy (if patients decline a skin biopsy they will NOT be excluded from the study).
结局指标
主要结局
Diagnosis of neuropathy
时间窗: Day 1
Toronto Clinical Scoring System of 4
次要结局
- 7-days pain diary(Day 1)
- Demographics(Day 1)
- Detailed medical history(Day 1)
- Pain related anxiety(Day 1)
- Measures of quality of life(Day 1)
- Measures of sleep interference(Day 1)
- Nerve Conduction Studies(Day 1)
- Sensory Thermal Thresholds(Day 1)
- Intra-Epidermal Nerve Fibre density(Day 1)
- Synovium tissue collection for RNA(Within 18 months of visit)
- Sensory Mechanical Detection Thresholds(Day 1)
- Blood samples - DNA(Within 6 months of visit)
- Blood samples - RNA(Within 18 months of visit)
- Blood samples - Serum(Within 18 months of visit)