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Version 2. Wellcome Open Res. 2019 Feb 1 [revised 2019 Feb 1];3:63. doi: 10.12688/wellcomeopenres.14576.2. eCollection 2018.

DOLORisk: study protocol for a multi-centre observational study to understand the risk factors and determinants of neuropathic pain.

Author information

1
Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, OX3 9DU, UK.
2
Division of Neurological Pain Research and Therapy, Department of Neurology, Universitätsklinikum Schleswig-Holstein, Kiel, 24105, Germany.
3
INSERM U-987, Centre d'Evaluation et de Traitement de la Douleur, APHP, CHU Ambroise Paré, Boulogne-Billancourt, France and University Versailles Saint Quentin en Yvelines, Versailles, 78000, France.
4
Department of Experimental-Clinical and Health Psychology, Ghent University, Ghent, 9000, Belgium.
5
Department of Clinical Medicine, Danish Pain Research Center, Aarhus University, Aarhus, 8000, Denmark.
6
Department of Neurology, Aarhus University Hospital, Aarhus, 8200, Denmark.
7
Department of Neurology, Rambam Health Care Campus, Technion Faculty of Medicine, Haifa, Israel.
8
Department of Clinical Sciences, Diabetes and Endocrinology, University of Lund, Malmö, Sweden.
9
Division of Population Health Sciences, University of Dundee, Dundee, DD1 9SY, UK.
10
MentisCura, Reykjavik, 105, Iceland.
11
Wellcome Trust Centre for Human Genetics, University of Oxford, Oxford, OX3 7BN, UK.
12
Centre for Pharmacogenetics and Pharmacogenomics, Medical Research Institute, Ninewells Hospital and School of Medicine, University of Dundee, Dundee, DD1 9SY, UK.
13
Pain Research Group, Imperial College London, London, SW10 9NH, UK.
14
Neuroscience Technologies, Ltd, Barcelona, Spain.

Abstract

Background: Neuropathic pain is an increasingly prevalent condition and has a major impact on health and quality of life. However, the risk factors for the development and maintenance of neuropathic pain are poorly understood. Clinical, genetic and psychosocial factors all contribute to chronic pain, but their interactions have not been studied in large cohorts. The DOLORisk study aims to study these factors. Protocol: Multicentre cross-sectional and longitudinal cohorts covering the main causes leading to neuropathic pain (e.g. diabetes, surgery, chemotherapy, traumatic injury), as well as rare conditions, follow a common protocol for phenotyping of the participants. This core protocol correlates answers given by the participants on a set of questionnaires with the results of their genetic analyses. A smaller number of participants undergo deeper phenotyping procedures, including neurological examination, nerve conduction studies, threshold tracking, quantitative sensory testing, conditioned pain modulation and electroencephalography. Ethics and dissemination: All studies have been approved by their regional ethics committees as required by national law. Results are disseminated through the DOLORisk website, scientific meetings, open-access publications, and in partnership with patient organisations. Strengths and limitations: Large cohorts covering many possible triggers for neuropathic painMulti-disciplinary approach to study the interaction of clinical, psychosocial and genetic risk factorsHigh comparability of the data across centres thanks to harmonised protocolsOne limitation is that the length of the questionnaires might reduce the response rate and quality of responses of participants.

KEYWORDS:

diabetes; nerve injury; neuropathic pain; neuropathy; pain; protocol; risk factors

Conflict of interest statement

Competing interests: DLB has acted as a consultant on behalf of Oxford Innovation for Abide, Biogen, GSK, Lilly, Mitsubishi Tanabe, Mundipharma and TEVA over the last 3 years. NA received speaker honoraria from Pfizer and reported fees for consultant services from Novartis, Teva, Grünenthal, Mundipharma, Sanofi Pasteur, Aptinyx. ASCR has received funding from Orion Pharma. ASCR undertakes consultancy and advisory board work for Imperial College Consultants—in the past 12 months, this has included remunerated work for: Merck, Galapagos, Toray, Quartet, Lateral, Novartis and Orion. ASCR was the owner of share options in Spinifex Pharmaceuticals from which personal benefit accrued on the acquisition of Spinifex by Novartis in July 2015 and from which future milestone payments may occur. ASCR is named as an inventor on patents: Rice A.S.C., Vandevoorde S. and Lambert D.M Methods using N-(2-propenyl)hexadecanamide and related amides to relieve pain, WO 2005/079771 (Google Patents); Okuse K. et al Methods of treating pain by inhibition of vgf activity, EP13702262.0/WO2013 110945 (Google Patents).

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