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      The Pain in Neuropathy Study (PiNS): a cross-sectional observational study determining the somatosensory phenotype of painful and painless diabetic neuropathy

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          Abstract

          Supplemental Digital Content is Available in the Text.

          The Pain in Neuropathy Study (PiNS), an observational cross-sectional multicentre study, demonstrated a positive correlation between greater diabetic neuropathy severity and the presence and severity of neuropathic pain.

          Abstract

          Disabling neuropathic pain (NeuP) is a common sequel of diabetic peripheral neuropathy (DPN). We aimed to characterise the sensory phenotype of patients with and without NeuP, assess screening tools for NeuP, and relate DPN severity to NeuP. The Pain in Neuropathy Study (PiNS) is an observational cross-sectional multicentre study. A total of 191 patients with DPN underwent neurological examination, quantitative sensory testing, nerve conduction studies, and skin biopsy for intraepidermal nerve fibre density assessment. A set of questionnaires assessed the presence of pain, pain intensity, pain distribution, and the psychological and functional impact of pain. Patients were divided according to the presence of DPN, and thereafter according to the presence and severity of NeuP. The DN4 questionnaire demonstrated excellent sensitivity (88%) and specificity (93%) in screening for NeuP. There was a positive correlation between greater neuropathy severity (r = 0.39, P < 0.01), higher HbA1c (r = 0.21, P < 0.01), and the presence (and severity) of NeuP. Diabetic peripheral neuropathy sensory phenotype is characterised by hyposensitivity to applied stimuli that was more marked in the moderate/severe NeuP group than in the mild NeuP or no NeuP groups. Brush-evoked allodynia was present in only those with NeuP (15%); the paradoxical heat sensation did not discriminate between those with (40%) and without (41.3%) NeuP. The “irritable nociceptor” subgroup could only be applied to a minority of patients (6.3%) with NeuP. This study provides a firm basis to rationalise further phenotyping of painful DPN, for instance, stratification of patients with DPN for analgesic drug trials.

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          Most cited references 50

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          The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection.

          A 36-item short-form (SF-36) was constructed to survey health status in the Medical Outcomes Study. The SF-36 was designed for use in clinical practice and research, health policy evaluations, and general population surveys. The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. The survey was constructed for self-administration by persons 14 years of age and older, and for administration by a trained interviewer in person or by telephone. The history of the development of the SF-36, the origin of specific items, and the logic underlying their selection are summarized. The content and features of the SF-36 are compared with the 20-item Medical Outcomes Study short-form.
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            Validation of the Insomnia Severity Index as an outcome measure for insomnia research.

             C. Bastien (2001)
            Background: Insomnia is a prevalent health complaint that is often difficult to evaluate reliably. There is an important need for brief and valid assessment tools to assist practitioners in the clinical evaluation of insomnia complaints.Objective: This paper reports on the clinical validation of the Insomnia Severity Index (ISI) as a brief screening measure of insomnia and as an outcome measure in treatment research. The psychometric properties (internal consistency, concurrent validity, factor structure) of the ISI were evaluated in two samples of insomnia patients.Methods: The first study examined the internal consistency and concurrent validity of the ISI in 145 patients evaluated for insomnia at a sleep disorders clinic. Data from the ISI were compared to those of a sleep diary measure. In the second study, the concurrent validity of the ISI was evaluated in a sample of 78 older patients who participated in a randomized-controlled trial of behavioral and pharmacological therapies for insomnia. Change scores on the ISI over time were compared with those obtained from sleep diaries and polysomnography. Comparisons were also made between ISI scores obtained from patients, significant others, and clinicians.Results: The results of Study 1 showed that the ISI has adequate internal consistency and is a reliable self-report measure to evaluate perceived sleep difficulties. The results from Study 2 also indicated that the ISI is a valid and sensitive measure to detect changes in perceived sleep difficulties with treatment. In addition, there is a close convergence between scores obtained from the ISI patient's version and those from the clinician's and significant other's versions.Conclusions: The present findings indicate that the ISI is a reliable and valid instrument to quantify perceived insomnia severity. The ISI is likely to be a clinically useful tool as a screening device or as an outcome measure in insomnia treatment research.
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              Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis.

              New drug treatments, clinical trials, and standards of quality for assessment of evidence justify an update of evidence-based recommendations for the pharmacological treatment of neuropathic pain. Using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE), we revised the Special Interest Group on Neuropathic Pain (NeuPSIG) recommendations for the pharmacotherapy of neuropathic pain based on the results of a systematic review and meta-analysis.
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                Author and article information

                Journal
                Pain
                Pain
                JPAIN
                Pain
                JOP
                Pain
                Wolters Kluwer (Philadelphia, PA )
                0304-3959
                1872-6623
                13 January 2016
                May 2016
                : 157
                : 5
                : 1132-1145
                Affiliations
                [a ]Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, United Kingdom
                [b ]Diabetes Research Unit, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom
                [c ]Structural & Molecular Biology, Division of Biosciences, University College London, London, United Kingdom
                [d ]Pain Research Group, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, Chelsea and Westminster Hospital Campus, London, United Kingdom
                [e ]Pain Medicine, Chelsea and Westminster Hospital NHS Foundation Trust, London, United Kingdom
                Author notes
                [* ]Corresponding author. Address: Nuffield Department of Clinical Neurosciences, University of Oxford, Level 6, West Wing, John Radcliffe Hospital, Headley Way, Headington, Oxford OX3 9DU, United Kingdom. Tel.: + 44 (0) 1865 231 512; fax: + 44 (0) 1865 231 534. E-mail address: david.bennett@ 123456ndcn.ox.ac.uk (D.L.H. Bennett).
                Article
                PAIN-D-14-14409 00019
                10.1097/j.pain.0000000000000491
                4834814
                27088890
                © 2016 International Association for the Study of Pain

                This is an open access article distributed under the terms of the Creative Commons Attribution License 4.0 (CC BY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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