DOLORisk: Research on Risk Factors and Determinants for Neuropathic Pain

The Influence of Sensory Phenotype on the Risk of Developing Neuropathic Pain

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.

Study Overview

• Status: Completed
• Conditions: Neuropathic Pain
• Intervention / Treatment: Diagnostic test: Quantitative sensory testing (QST)

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.

• Study Type: Observational
• Enrollment (Actual): 1550

Contacts and Locations

Study Locations

• Germany
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • University of Kiel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Quantitative 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).; Other Names: Different Questionnaires
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.	Diagnostic test: Quantitative 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).; Other Names: Different Questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Kiel
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; Aarhus University Hospital; Imperial College London; University of Aarhus; University of Oxford; Technion, Israel Institute of Technology; Horizon 2020 - European Commission
• Investigators: Study Director: David Bennett, Prof., University of Oxford

Publications and helpful links

General Publications

• 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.

Helpful Links

• Study protocol

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2015
• Primary Completion (ACTUAL): June 1, 2019
• Study Completion (ACTUAL): June 1, 2019

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (ACTUAL): May 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: patient-reported outcomes; PRO; QST; pain prevention; painful neuropathy,; painless neuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: 633491 - DOLORisk WP4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No