Pain In Neuropathy Study

NCT02672059 | Unknown

• 2 other identifiers: 10/H0706/0359755
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Neuropathy; Neuropathic Pain; Chronic Pain; Carpal Tunnel Syndrome; Peripheral Neuropathies

Outcome Measures

Primary Outcomes (1)

• Diagnosis of neuropathy

  Toronto Clinical Scoring System of 4

  Day 1

Secondary Outcomes (14)

• Demographics

  Day 1

• Detailed medical history

  Day 1

• 7-days pain diary

  Day 1

• Pain related anxiety

  Day 1

• Measures of quality of life

  Day 1

Study Arms (1)

Peripheral Neuropathy

Patients with peripheral neuropathy (observational study, no interventions)

Other: Observation

Interventions

Observation OTHER

No intervention

Peripheral Neuropathy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with peripheral neuropathies associated with diabetes, carpal tunnel syndrome or others.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• King's College London: lead
• University of Oxford: collaborator
• Imperial College London: collaborator
• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Nuffield Department of Clinical Neurosciences

Oxford, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

Related Publications (4)

• Phillips TJC, Brown M, Ramirez JD, Perkins J, Woldeamanuel YW, Williams ACC, Orengo C, Bennett DLH, Bodi I, Cox S, Maier C, Krumova EK, Rice ASC. Sensory, psychological, and metabolic dysfunction in HIV-associated peripheral neuropathy: A cross-sectional deep profiling study. Pain. 2014 Sep;155(9):1846-1860. doi: 10.1016/j.pain.2014.06.014. Epub 2014 Jun 26.

  PMID: 24973717 BACKGROUND

• Schmid AB, Bland JD, Bhat MA, Bennett DL. The relationship of nerve fibre pathology to sensory function in entrapment neuropathy. Brain. 2014 Dec;137(Pt 12):3186-99. doi: 10.1093/brain/awu288. Epub 2014 Oct 27.

  PMID: 25348629 RESULT

• Ramirez JD, Barnes PRJ, Mills KR, Bennett DLH. Intermediate Charcot-Marie-Tooth disease due to a novel Trp101Stop myelin protein zero mutation associated with debilitating neuropathic pain. Pain. 2012 Aug;153(8):1763-1768. doi: 10.1016/j.pain.2012.05.015. Epub 2012 Jun 16.

  PMID: 22704856 RESULT

• Segerdahl AR, Xie J, Paterson K, Ramirez JD, Tracey I, Bennett DLH. Imaging the neural correlates of neuropathic pain and pleasurable relief associated with inherited erythromelalgia in a single subject with quantitative arterial spin labelling. Pain. 2012 May;153(5):1122-1127. doi: 10.1016/j.pain.2011.12.012. Epub 2012 Feb 24.

  PMID: 22365309 RESULT

Related Links

• A team at the University of Oxford would like to recruit people aged over 18 who have diabetes and neuropathy to a study of the causes of neuropathic pain. Their findings could inform the development of new therapies. (Recruiting until June 2017)

Biospecimen

Retention: SAMPLES WITH DNA

1. 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. 2. IENFD assessed via one 3mm skin punch biopsies performed 10 cm above lateral malleolus.

MeSH Terms

Conditions

Diabetic Neuropathies; Neuralgia; Chronic Pain; Carpal Tunnel Syndrome; Peripheral Nervous System Diseases

Interventions

Observation

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: February 3, 2016
• Study Start: February 1, 2011
• Primary Completion: June 1, 2021
• Last Updated: September 17, 2019

Record last verified: 2019-09

Locations

GB (1)