Neuropathic Pain
Conditions
Keywords
pain prevention, painful neuropathy,, painless neuropathy, QST, patient-reported outcomes, PRO
Brief summary
Patients with neuropathic pain of multiple etiologies and a control cohort of patients with the same neuropathic entities who did not develop neuropathic pain are examined clinically, phenotyped with QST and questionnaires. Both groups are analyzed in order to find risk factors for painful neuropathy.
Detailed description
Patients with probable (presence of a combination of symptoms and signs of neuropathy include any two or more of the following: neuropathic symptoms, decreased distal sensation, or unequivocally decreased or absent ankle reflexes) or confirmed (presence of an abnormality of NC or validated measure of small fiber neuropathy with class 1 evidence with corresponding symptoms) neuropathy are included. Patients are then further divided into those with painful and painless neuropathy according to the NeuPSIG algorithm. Patients with probable or definite neuropathic pain are classified as painful neuropathy, those with unlikely neuropathic pain classified as painless neuropathy (with concomitant nociceptive pain of other origin, e.g. headache etc.). Patients with possible neuropathic pain are excluded from analysis as are patients with skin lesions or dermatological disorders in the areas to be tested upon QST, with any painful or neurological comorbidity that could otherwise influence testing results such as vascular disease, radiculopathy, spinal canal stenosis etc. Inclusion was restricted to patients with polyneuropathy to make the investigated patient sample as homogenous as possible. Age, gender, BMI, ethnicity, years in education, family history of chronic pain, etiology of neuropathy, presence of early traumatic events and hospital admissions, smoking and alcohol habits, pain characteristics (von Korff, BPSI, NPSI), emotional well-being (PROMIS depression/ anxiety), personality (TIPI, IPIP, PCS), severity of neuropathy are assessed and QST performed.
Interventions
DIAGNOSTIC_TESTQuantitative sensory testing (QST)
Demographic data, pain characteristics, health status, emotional well-being, personality and lifestyle are assessed by questionnaires. Additionally, all patients underwent a clinical neurological examination and quantitative sensory testing (QST) according to the German Research Network on Neuropathic Pain (DFNS).
Sponsors
Horizon 2020 - European Commission
Institut National de la Santé Et de la Recherche Médicale, France
University of Oxford
Imperial College London
Technion, Israel Institute of Technology
University of Aarhus
Aarhus University Hospital
University of Kiel
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Diagnosis of Polyneuropathy
Exclusion criteria
* Patients with polyneuropathy and possible neuropathic pain * Patients with skin lesions or dermatological disorders in the areas to be tested upon QST * Patients with any painful or neurological comorbidity that could otherwise influence testing results such as vascular disease, radiculopathy, spinal canal stenosis etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Pain measured by Pain severity | through study completion, an average of 2 years | Measurement on NRS \[NRS 0-10\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Somatosensory phenotype measured by Quantitative sensory testing | through study completion, an average of 2 years | Assessment of somatosensory phenotype with the protocol of the German REsearch Network of Neuropathic Pain (DFNS) |
| Emotional well-being | through study completion, an average of 2 years | assessed by anxiety PROMIS Short Form v1.0 -Anxiety 6a, Depression 6a, Fatigue and Sleep |
| Severity of Neuropathy measured by Toronto Neuropathy scale | through study completion, an average of 2 years | Total Score \[0-19 points\] from history and clinical examination |
| Pain Catastrophizing | through study completion, an average of 2 years | assessed by Pain Catastrophizing scale (PCS) total score \[0-52 points\] |
| Presence of family history of chronic pain | through study completion, an average of 2 years | Presence of pain in family |
| Personality characteristics | through study completion, an average of 2 years | assessed by Ten-Item Personality Inventory and International Personality Item Pool's |
Countries
Germany
Outcome results
None listed