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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
Sponsor:
Collaborators:
University of Oxford
Imperial College London
Sheffield Teaching Hospital NHS Foundation Trust
Information provided by (Responsible Party):
King's College London

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.


Condition or disease Intervention/treatment
Diabetic Neuropathy Neuropathic Pain Chronic Pain Carpal Tunnel Syndrome Peripheral Neuropathies Other: Observation

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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Pain In Neuropathy Study
Study Start Date : February 2011
Estimated Primary Completion Date : June 2021


Group/Cohort Intervention/treatment
Peripheral Neuropathy
Patients with peripheral neuropathy (observational study, no interventions)
Other: Observation
No intervention




Primary Outcome Measures :
  1. Diagnosis of neuropathy [ Time Frame: Day 1 ]
    Toronto Clinical Scoring System of 4


Secondary Outcome Measures :
  1. Demographics [ Time Frame: Day 1 ]
    Main demographic visits

  2. Detailed medical history [ Time Frame: Day 1 ]
    Past clinical records of patients relevant to the current disease status

  3. 7-days pain diary [ Time Frame: Day 1 ]
    Patients will have 7-days pain diaries with a numeric rating scale from 0 to 10

  4. Pain related anxiety [ Time Frame: Day 1 ]
    Patients will answer the Pain Anxiety Symptoms Scale (PASS-20)

  5. Measures of quality of life [ Time Frame: Day 1 ]
    Patients will answer the 36-Item Short Form Survey -quality of life questionnaire-

  6. Measures of sleep interference [ Time Frame: Day 1 ]
    Sleep quality is assessed through the use of questionnaires

  7. Nerve Conduction Studies [ Time Frame: Day 1 ]
    Neurophysiology will be conducted to assess nerve integrity

  8. Sensory Thermal Thresholds [ Time Frame: Day 1 ]
    Thermal thresholds will be measured in degrees centigrade

  9. Sensory Mechanical Detection Thresholds [ Time Frame: Day 1 ]
    Mechanical Detection Thresholds will be measured in millinewtons

  10. Intra-Epidermal Nerve Fibre density [ Time Frame: Day 1 ]
    Measurement of nerve fibres in the skin of patients - leg or finger-

  11. 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

  12. 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

  13. 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

  14. 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
  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.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects with peripheral neuropathies associated with diabetes, carpal tunnel syndrome or others.
Criteria

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 (if patients decline a skin biopsy they will NOT be excluded from the study).

Information from the National Library of Medicine

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


Locations
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United Kingdom
Nuffield Department of Clinical Neurosciences Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Contact: Andreas Themistocleous, PhD    +44 1865234543    andreas.themistocleous@ndcn.ox.ac.uk   
Contact: Mathilde Pascal    +44 1865223374    mathilde.pascal@ndcn.ox.ac.uk   
Principal Investigator: David L H Bennett, MD PhD         
Sponsors and Collaborators
King's College London
University of Oxford
Imperial College London
Sheffield Teaching Hospital NHS Foundation Trust
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT02672059    
Other Study ID Numbers: 10/H0706/035
9755 ( Other Identifier: UK Clinical Research Network )
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuralgia
Carpal Tunnel Syndrome
Diabetic Neuropathies
Chronic Pain
Pain
Neurologic Manifestations
Neuromuscular Diseases
Nervous System Diseases
Median Neuropathy
Mononeuropathies
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases