Abstract
PurposeThis study aims to explore the changes in pain intensity and quality of life (QoL) experienced by patients with painful diabetic neuropathy (PDN) treated with spinal cord stimulation (SCS) and conventional medical practice (CMP).MethodsPatient-reported pain intensity and QoL data were obtained from participants in an international multicentre randomised controlled trial comparing SCS versus CMP. Data were collected at randomisation and 6 month follow up by means of a visual analogue scale for pain intensity, the EuroQoL Visual Analogue Scale (EQ VAS) and the EuroQol EQ-5D index. Quality-adjusted life years (QALYs) were calculated for each treatment using the ‘area under the curve’ method. Differences in QALYs were calculated after adjusting for between-treatment imbalances in baseline QoL.ResultsAt 6 months, patients allocated to SCS reported larger reductions in pain intensity and improvements in QoL measured by the EQ-5D utility score and EQ VAS as compared to those allocated to CMP. Initial calculations of QALYs for the SCS and CMP groups suggested no statistical differences between the groups. Adjusting for imbalances in baseline EQ-5D scores showed SCS to be associated with significantly higher QALYs compared to CMP.ConclusionsSCS resulted in significant improvement in pain intensity and QoL in patients with PDN, offering further support for SCS as an effective treatment for patients suffering from PDN. From a methodological point of view, different results would have been obtained if QALY calculations were not adjusted for baseline EQ-5D scores, highlighting the need to account for imbalances in baseline QoL.
Highlights
Diabetes mellitus is a common chronic condition with an increasing prevalence estimated to reach 4.4 % of the world population in 2030, the equivalent of 366 million people [1]
Purpose This study aims to explore the changes in pain intensity and quality of life (QoL) experienced by patients with painful diabetic neuropathy (PDN) treated with spinal cord stimulation (SCS) and conventional medical practice (CMP)
At 6 months, patients allocated to SCS reported larger reductions in pain intensity and improvements in QoL measured by the EQ-5D utility score and EuroQoL Visual Analogue Scale (EQ VAS) as compared to those allocated to CMP
Summary
Diabetes mellitus is a common chronic condition with an increasing prevalence estimated to reach 4.4 % of the world population in 2030, the equivalent of 366 million people [1]. As a result of the condition, approximately one in every three diabetic patients is expected to develop painful diabetic neuropathy (PDN) [2, 3]. PDN is defined as pain arising as a result of abnormalities in the peripheral somatosensory system in people with diabetes [4], and it is considered the most disabling and costly complication of diabetes. Several studies have reported that patients with neuropathic pain experience lower levels of health-related quality of life (QoL) when compared to the general population [5, 6]. PDN may interfere substantially with QoL aspects such as general activity, mood, mobility, self-care, recreational and social activities [7].
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