Synergistic Effects of Vitamin D and Mindfulness Training in Pain Severity, Pain-Related Disability and Neuropathy-Specific Quality of Life Dimensions in Painful Diabetic Neuropathy: A Randomized Clinical Trial with Placebo-controlled

Abstract

Background: This study aimed to examining Synergistic effect of Vitamin D (VD) Supplement and mindfulness on neuropathic pain severity, Pain-Related Disability and Neuropathy-Specific Quality of Life dimensions in painful diabetic neuropathy.Methods: In this randomized controlled trial, totally 225 patients with painful diabetic neuropathy were randomly allocated to five groups: (1) mindfulness and placebo, (2) placebo, (3) mindfulness, (4) VD, and (5) mindfulness and VD. Mindfulness training includes twelves sessions and VD patients received a daily four thousand IU oral dosage (four capsules) with 28,000 IU vitamin D weekly for 12 weeks. Laboratory analyses, Sun exposure time, Vitamin D intake, BMI and Physical activity measured in pre-test and posttest. Pain-Related Disability measured with The Pain Disability Index (PDI). For other outcome variables Neuropathy Specific Quality of Life questionnaire and Neuropathic pain severity scale was utilized.Results: In baseline, measures were not different among the groups. At the end-of-treatment, for outcome variables results showed improvement in all groups except the “placebo” group. About other groups, there was not any difference between VD and mindfulness groups (in and not combined with placebo). However, “VD + mindfulness” has a greater improvement rather than VD and mindfulness groups (P<0.05). Moreover, both protocols have no significant effects on, FBS, BMI and energy intakes (P>0.05).Conclusion: Combining VD and mindfulness can reduce pain severity and pain-related disability, so with these changes patients improve their quality of life.