Pain In Neuropathy Study (NCT02672059) | Clinical Trial Compass
UnknownNot Applicable
Pain In Neuropathy Study
United Kingdom700 participantsStarted 2011-02
Plain-language summary
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.
2\. 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.
3\. 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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…