Clinical trial NCT04888455: DOLORisk: Research on Risk Factors and Determinants for Neuropathic Pain
Official title: The Influence of Sensory Phenotype on the Risk of Developing Neuropathic Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuropathic Pain
Keywords: pain prevention
painful neuropathy,
painless neuropathy
QST
patient-reported outcomes
PRO
Lead sponsor: University of Kiel
Sponsor class: OTHER
Collaborators: name: Horizon 2020 - European Commission
name: Institut National de la Santé Et de la Recherche Médicale, France
name: University of Oxford
name: Imperial College London
name: Technion, Israel Institute of Technology
name: University of Aarhus
name: Aarhus University Hospital
First posted: 2021-05-17
Enrollment: 1550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Presence of Pain measured by Pain severity
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Severity of Neuropathy measured by Toronto Neuropathy scale
timeFrame: through study completion, an average of 2 years
measure: Somatosensory phenotype measured by Quantitative sensory testing
timeFrame: through study completion, an average of 2 years
measure: Emotional well-being
timeFrame: through study completion, an average of 2 years
measure: Personality characteristics
timeFrame: through study completion, an average of 2 years
measure: Pain Catastrophizing
timeFrame: through study completion, an average of 2 years
measure: Presence of family history of chronic pain
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: University of Kiel
state: Schleswig-Holstein
Study officials:
affiliation: University of Oxford
name: David Bennett, Prof.
role: STUDY_DIRECTOR
References:
citation: 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.