Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Horizon 2020 - European Commission | OTHER |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| University of Oxford | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Painful neuropathy | Patients with presence of 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 AND with probable or definite neuropathic pain according to the NeuPSIG algorithm. |
| |
| Painless neuropathy | Patients with presence of 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 AND with unlikely neuropathic pain according to the NeuPSIG algorithm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantitative sensory testing (QST) | Diagnostic Test | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Pain measured by Pain severity | Measurement on NRS [NRS 0-10] | through study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Neuropathy measured by Toronto Neuropathy scale | Total Score [0-19 points] from history and clinical examination | through study completion, an average of 2 years |
| Somatosensory phenotype measured by Quantitative sensory testing |
Not provided
Inclusion Criteria:
- Diagnosis of Polyneuropathy
Exclusion Criteria:
Not provided
Not provided
Not provided
In- and outpatients with presence of 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. Patients are then further divided into those with painful and painless neuropathy according to the NeuPSIG algorithm.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Bennett, Prof. | University of Oxford | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kiel | Kiel | Schleswig-Holstein | 24105 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30756091 | Background | Pascal MMV, Themistocleous AC, Baron R, Binder A, Bouhassira D, Crombez G, Finnerup NB, Gierthmuhlen J, Granovsky Y, Groop L, Hebert HL, Jensen TS, Johnsen K, McCarthy MI, Meng W, Palmer CNA, Rice ASC, Serra J, Sola R, Yarnitsky D, Smith BH, Attal N, Bennett DLH. DOLORisk: study protocol for a multi-centre observational study to understand the risk factors and determinants of neuropathic pain. Wellcome Open Res. 2019 Feb 1;3:63. doi: 10.12688/wellcomeopenres.14576.2. eCollection 2018. | |
| 38968400 |
| Label | URL |
|---|---|
| Study protocol | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| C564945 | Neuropathy, Painful |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
Not provided
Not provided
| Imperial College London |
| OTHER |
| Technion, Israel Institute of Technology | OTHER |
| University of Aarhus | OTHER |
| Aarhus University Hospital | OTHER |
Not provided
Not provided
Not provided
|
|
Assessment of somatosensory phenotype with the protocol of the German REsearch Network of Neuropathic Pain (DFNS)
| through study completion, an average of 2 years |
| Emotional well-being | assessed by anxiety PROMIS Short Form v1.0 -Anxiety 6a, Depression 6a, Fatigue and Sleep | through study completion, an average of 2 years |
| Personality characteristics | assessed by Ten-Item Personality Inventory and International Personality Item Pool's | through study completion, an average of 2 years |
| Pain Catastrophizing | assessed by Pain Catastrophizing scale (PCS) total score [0-52 points] | through study completion, an average of 2 years |
| Presence of family history of chronic pain | Presence of pain in family | through study completion, an average of 2 years |
| Derived |
| Gierthmuhlen J, Attal N, Baskozos G, Bennedsgaard K, Bennett DL, Bouhassira D, Crombez G, Finnerup NB, Granovsky Y, Jensen TS, John J, Kennes LN, Laycock H, Pascal MMV, Rice ASC, Shafran-Topaz L, Themistocleous AC, Yarnitsky D, Baron R. What is associated with painful polyneuropathy? A cross-sectional analysis of symptoms and signs in patients with painful and painless polyneuropathy. Pain. 2024 Dec 1;165(12):2888-2899. doi: 10.1097/j.pain.0000000000003310. Epub 2024 Jul 3. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |