DOLORisk: Research on Risk Factors and Determinants for Neuropathic Pain

NCT04888455 | Completed

• 1 other identifier: 633491 - DOLORisk WP4
• Study Type: observational
• Target: 1,550
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain

Keywords

pain prevention; painful neuropathy,; painless neuropathy; QST; patient-reported outcomes; PRO

Outcome Measures

Primary Outcomes (1)

• Presence of Pain measured by Pain severity

  Measurement on NRS \[NRS 0-10\]

  through study completion, an average of 2 years

Secondary Outcomes (6)

• Severity of Neuropathy measured by Toronto Neuropathy scale

  through study completion, an average of 2 years

• Somatosensory phenotype measured by Quantitative sensory testing

  through study completion, an average of 2 years

• Emotional well-being

  through study completion, an average of 2 years

• Personality characteristics

  through study completion, an average of 2 years

• Pain Catastrophizing

  through study completion, an average of 2 years

Study Arms (2)

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)

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)

Interventions

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).

Also known as: Different Questionnaires

Painful neuropathy; Painless neuropathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- Diagnosis of Polyneuropathy

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kiel: lead
• Horizon 2020 - European Commission: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• University of Oxford: collaborator
• Imperial College London: collaborator
• Technion, Israel Institute of Technology: collaborator
• University of Aarhus: collaborator
• Aarhus University Hospital: collaborator

Study Sites (1)

University of Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Location

Related Publications (2)

• 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.

  PMID: 30756091 BACKGROUND

• 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.

  PMID: 38968400 DERIVED

Related Links

• Study protocol

MeSH Terms

Conditions

Neuralgia; Neuropathy, Painful

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Bennett, Prof.

  University of Oxford

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 17, 2021
• Study Start: June 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)