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A dietary intervention for chronic diabetic neuropathy pain: a randomized controlled pilot study.

ABSTRACT: Diabetic neuropathy is a common and often debilitating condition for which available treatments are limited. Because a low-fat plant-based diet has been shown to improve glycemic control in individuals with type 2 diabetes, we hypothesized that such a diet would reduce painful symptoms of diabetic neuropathy.In this 20-week pilot study, individuals with type 2 diabetes and painful diabetic neuropathy were randomly assigned to two groups. The intervention group was asked to follow a low-fat, plant-based diet, with weekly classes for support in following the prescribed diet, and to take a vitamin B12 supplement. The control group was asked to take the same vitamin B12 supplement, but received no other intervention. At baseline, midpoint and 20 weeks, clinical, laboratory and questionnaire data were collected. Questionnaires included an analog 'worst pain' scale, Michigan Neuropathy Screening Instrument, global impression scale, Short Form McGill Pain Questionnaire, Neuropathy Total Symptom Score, a weekly pain diary and Norfolk Quality of Life Questionnaire.After 20 weeks, body weight change with the intervention was -6.4?kg (95% confidence interval (CI) -9.4 to -3.4, P<0.001) in an effect size analysis. Electrochemical skin conductance in the foot improved by an average of 12.4 microseimens (95% CI 1.2-23.6, P=0.03) with the intervention in an effect size analysis. The between-group difference in change in pain, as measured by the McGill pain questionnaire, was -8.2 points (95% CI -16.1 to -0.3, P=0.04). Michigan Neuropathy Screening Instrument questionnaire score change was -1.6 points (95% CI -3.0 to -0.2, P=0.03).Improvements were seen in some clinical and pain measures. This pilot study suggests the potential value of a plant-based diet intervention, including weekly support classes, for treating painful diabetic neuropathy.

SUBMITTER: Bunner AE

PROVIDER: S-EPMC4450462 | biostudies-literature | 2015 May

REPOSITORIES: biostudies-literature

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A dietary intervention for chronic diabetic neuropathy pain: a randomized controlled pilot study.

Bunner A E AE Wells C L CL Gonzales J J Agarwal U U Bayat E E Barnard N D ND

Nutrition & diabetes 20150526

<h4>Background</h4>Diabetic neuropathy is a common and often debilitating condition for which available treatments are limited. Because a low-fat plant-based diet has been shown to improve glycemic control in individuals with type 2 diabetes, we hypothesized that such a diet would reduce painful symptoms of diabetic neuropathy.<h4>Methods</h4>In this 20-week pilot study, individuals with type 2 diabetes and painful diabetic neuropathy were randomly assigned to two groups. The intervention group ...[more]

PMID: 26011582

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Project description:BackgroundChronic pain is a common and costly condition in youth, associated with negative implications that reach far beyond the pain experience itself (e.g., interference with recreational, social, and academic activities, mental health sequelae). As a self-appraised condition, pain experience is influenced by patient's biases and meaning-making in relation to their symptoms and triggers. We propose that interacting with self-reported data will impact the experience of pain by altering understanding and expectations of symptom experience and how pain interacts with other factors (e.g., sleep, emotions, social interactions). In this study, we aim to establish the feasibility and acceptability of using a data visualization platform to track and monitor symptoms and their relationship with other factors, versus simply daily reporting of symptoms using a smartphone-based Ecological Momentary Assessment (EMA).MethodsThis protocol is for a randomized, single-center, open-label crossover trial. We aim to recruit 50 typically developing youth aged 12-18 years with chronic pain to take part in two phases of data collection. The trial will utilize an A-B counterbalanced design in which participants will be randomly assigned to receive either Part A (EMA alone for 7 days) or Part B (EMA plus visualization platform for 7 days) first and then receive the opposite phase after a 7-day break (washout period). Key outcomes will be participant reports of acceptability and feasibility, EMA completion rates, barriers, and perceptions of the benefits or risks of participation. Secondary exploratory analyses will examine the relationship between EMA-reported symptoms over time and in relation to baseline measures, as well as pilot data on any improvements in symptoms related to engaging with the data visualization platform.DiscussionThis protocol describes the feasibility and pilot testing of a novel approach to promoting self-management and facilitating symptom appraisal using visualized data. We aim to determine whether there is a sufficient rationale, both from the perspective of feasibility and patient satisfaction/acceptability, to conduct a larger randomized controlled trial of this intervention. This intervention has the potential to support clinical care for youth with chronic pain and other conditions where self-appraisal and understanding of symptom patterns are a critical component of functional recovery.Trial registrationOpen Science Framework doi: https://doi.org/10.17605/OSF.IO/HQX7C . Registered on October 25, 2021, osf.io/hqx7c.

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Project description:BackgroundA significant proportion of older women suffer from chronic pain, which can decrease quality of life. The objective of this pilot randomized study was to evaluate the feasibility of a flow-restorative yoga intervention designed to decrease pain and related outcomes among women aged 60 or older.MethodsFlow-restorative yoga classes were held twice weekly for 1 hour and led by a certified yoga instructor. Participants randomized to the intervention group attended the yoga classes for 12 weeks and received supplemental materials for at-home practice. Those randomized to the control group were asked to maintain their normal daily routine. Feasibility was evaluated using recruitment and retention rates, class and home practice adherence rates, and participant satisfaction surveys. Outcome measures (self-reported pain, inflammatory markers, functional fitness, quality of life, resilience, and self-reported physical activity) were assessed at baseline and post-intervention. Paired t-tests or Wilcoxon signed-rank tests were used to examine changes in outcome measures within treatment groups.ResultsThirty-eight participants were recruited and randomized. Participants were primarily white, college-educated, and higher functioning, despite experiencing various forms of chronic pain. Attendance and retention rates were high (91 and 97%, respectively) and the majority of participants were satisfied with the yoga program (89%) and would recommend it to others (87%). Intervention participants also experienced reductions in pain interference and improvements in energy and social functioning.ConclusionsThis pilot study provides essential data to inform a full scale randomized trial of flow-restorative yoga for older women with chronic pain. Future studies should emphasize strategies to recruit a more diverse study population, particularly older women at higher risk of disability and functional decline.Trial registrationClinicaltrials.gov , NCT03790098 . Registered 31 December 2018 - Retrospectively registered.

Project description:BackgroundCardiac surgery is a frequently performed procedure. However, pain after cardiac surgery may become chronic (lasting >3 months) in adults. Once discharged from the hospital, patients are at greater risk of developing chronic postsurgical pain (CPSP) and of prolonged opioid use, as they need to self-manage their pain. Psychological risk and protective factors such as pain-related catastrophic thoughts and pain acceptance determine their ability to cope and their use of opioids, which is crucial for self-management of pain. Studies on mindfulness-based cognitive therapy (MBCT) have multiplied their potential effects on pain acceptance and catastrophic thoughts. However, web-based MBCT for the prevention of CPSP has not yet been examined.ObjectiveThe aim of this study is to pilot test a 4-week-long web-based MBCT intervention for adults following discharge from the hospital by assessing the acceptability or feasibility of the intervention and examining preliminary effects on pain intensity, pain interference with activities and opioid use, and pain acceptance and catastrophic thoughts in the 6 months following surgery.MethodsA double-blinded pilot randomized controlled trial will be used to assess a web-based MBCT intervention. Patients will be selected according to the following criteria: age ≥18 years; first-time elective cardiac surgery via a median sternotomy; worst pain in the past week score ≥4/10; ability to understand and complete questionnaires in English; and ability to use an electronic device such as a smartphone, computer, or tablet. After baseline measures, 32 participants will be randomized into two groups: one receiving both the brief, 4-week-long web-based MBCT intervention and usual care (experimental group) and the other receiving only one standardized, web-based educational session with weekly reminders and usual care (attention control group). Peer-reviewed competitive funding was received from Florida State University's Council on Research & Creativity in January 2021, as well as research ethics approval from Florida State University's institutional review board.ResultsRecruitment began in June 2021. Unfortunately, because of the current COVID-19 pandemic, recruitment is not progressing as expected. Recruitment strategies are constantly monitored and updated according to latest data and restrictions surrounding the pandemic.ConclusionsThis research is significant because it targets the trajectory of CPSP, a leading cause of disability and opioid misuse. This is the first study to assess MBCT for the prevention of CPSP after cardiac surgery in the recovery phase. This approach is innovative because it promotes self-management of pain through the modulation of individual factors. If successful, the intervention could be expanded to numerous populations at risk of chronic pain.International registered report identifier (irrid)DERR1-10.2196/30951.

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A dietary intervention for chronic diabetic neuropathy pain: a randomized controlled pilot study.

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A dietary intervention for chronic diabetic neuropathy pain: a randomized controlled pilot study.

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