Pain In Neuropathy Study (PINS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02672059|
Recruitment Status : Recruiting
First Posted : February 3, 2016
Last Update Posted : September 17, 2019
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.
|Condition or disease||Intervention/treatment|
|Diabetic Neuropathy Neuropathic Pain Chronic Pain Carpal Tunnel Syndrome Peripheral Neuropathies||Other: Observation|
|Study Type :||Observational|
|Estimated Enrollment :||700 participants|
|Official Title:||Pain In Neuropathy Study|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||June 2021|
Patients with peripheral neuropathy (observational study, no interventions)
- Diagnosis of neuropathy [ Time Frame: Day 1 ]Toronto Clinical Scoring System of 4
- Demographics [ Time Frame: Day 1 ]Main demographic visits
- Detailed medical history [ Time Frame: Day 1 ]Past clinical records of patients relevant to the current disease status
- 7-days pain diary [ Time Frame: Day 1 ]Patients will have 7-days pain diaries with a numeric rating scale from 0 to 10
- Pain related anxiety [ Time Frame: Day 1 ]Patients will answer the Pain Anxiety Symptoms Scale (PASS-20)
- Measures of quality of life [ Time Frame: Day 1 ]Patients will answer the 36-Item Short Form Survey -quality of life questionnaire-
- Measures of sleep interference [ Time Frame: Day 1 ]Sleep quality is assessed through the use of questionnaires
- Nerve Conduction Studies [ Time Frame: Day 1 ]Neurophysiology will be conducted to assess nerve integrity
- Sensory Thermal Thresholds [ Time Frame: Day 1 ]Thermal thresholds will be measured in degrees centigrade
- Sensory Mechanical Detection Thresholds [ Time Frame: Day 1 ]Mechanical Detection Thresholds will be measured in millinewtons
- Intra-Epidermal Nerve Fibre density [ Time Frame: Day 1 ]Measurement of nerve fibres in the skin of patients - leg or finger-
- Blood samples - DNA [ Time Frame: Within 6 months of visit ]Blood samples coupled with detailed phenotype data will investigate potential gene associations in the development of painful neuropathy
- Blood samples - RNA [ Time Frame: Within 18 months of visit ]Blood samples coupled with detailed phenotype data will investigate potential blood markers associations in the development of painful neuropathy
- Blood samples - Serum [ Time Frame: Within 18 months of visit ]Blood samples coupled with detailed phenotype data will investigate potential blood markers associations only in the development of painful neuropathy
- Synovium tissue collection for RNA [ Time Frame: Within 18 months of visit ]Synovium from around the nerve and tendons coupled with detailed phenotype data will investigate potential blood markers associations only in the development of painful neuropathy
Biospecimen Retention: Samples With DNA
- We will collect blood samples (30mls) from each subject, which will be stored at -800C in a locked freezer. All samples will eventually be transported to King's College for storage in compliance with The Human Tissues Act. DNA will be taken for studies in genetics polymorphisms or mutations within genes which may modify the risk of a person developing a neuropathic pain and/or the severity of neuropathic pain, if and only if patients agree. Genetic analysis will be strictly restricted to the neuropathic pain field, and data will be anonymised after blood has been taken from patients. If blood chemistry and HbA1c is not available from primary care, these will also be checked. We will also assess new potential metabolic biomarkers in the serum of patients that can shed a light into mechanisms for the development of neuropathy and pain.
- IENFD assessed via one 3mm skin punch biopsies performed 10 cm above lateral malleolus.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672059
|Nuffield Department of Clinical Neurosciences||Recruiting|
|Oxford, Oxfordshire, United Kingdom, OX3 9DU|
|Contact: Andreas Themistocleous, PhD +44 1865234543 email@example.com|
|Contact: Mathilde Pascal +44 1865223374 firstname.lastname@example.org|
|Principal Investigator: David L H Bennett, MD PhD|