The Effect of Mindfulness Based Stress Reduction in Patients With Painful Diabetic Peripheral Neuropathy
CompletedNot applicableNCT02127762
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Brief summary (from the registry)
By 2020, it is estimated that 3.7 million Canadians will have diabetes mellitus, with type 2 diabetes (T2DM) accounting for more than 90% of cases. Estimates of the prevalence of diabetic peripheral neuropathy among adults with T2DM range from 26% to 47%. It increases with patient age and duration of disease and it can be as high as 60 to 70% in older cohorts. Diabetic peripheral neuropathy is documented in most studies as numbness, tingling, pain and/or objective sensory changes. Pain is an early manifestation of neuropathy and may be the presenting symptom of diabetes. Even the best medications and procedures rarely relieve more than 30% of the discomfort of chronic painful conditions. Diabetic patients continue to experience debilitating and disabling pain. Pain affects our ability to work, our ability to participate in recreational activities, our mood and our relationships. It is well-established that an interdisciplinary approach is key to the treatment of some types of chronic pain, but little research has been done on the effectiveness of interdisciplinary treatments for patients suffering from painful diabetic peripheral neuropathy. The investigators will evaluate the effectiveness of an interdisciplinary approach combining medical treatment and mindfulness-based stress reduction (MBSR) to reduce disability and improve quality of life among patients with painful diabetic peripheral neuropathy. The investigators will also evaluate the impact of the program on psychological distress, pain cognitions, and biomarkers of stress and glycemic function.
Study details
- Official title
- The Effect of an Inter-Disciplinary Program, Including Mindfulness Based Stress Reduction, on Psychosocial Function, Pain and Metabolism in Patients With Painful Diabetic Peripheral Neuropathy
- Conditions
- Diabetes Mellitus
- Type I Diabetes
- Type II Diabetes
- Diabetic Peripheral Neuropathy
- Chronic Pain
- Interventions
- Sponsor
- Ottawa Hospital Research Institute
- Collaborators
- Canadian Diabetes Association
- Start date
- 2012-09
- Primary completion
- 2016-06
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Patient aged \> 18 years * Type 1 or Type 2 Diabetes Mellitus (receiving insulin or not) * HbA1c 6.5%-9.9% * Diagnosis of Diabetic Peripheral Neuropathy (DPN) \> 1 year * Report of pain \> 6 months * Score \>3 on Douleur Neuropathique-4 Questionnaire * VAS completed 5/7 days; Average VAS score \>4 and \<9 (i.e., moderate to severe pain). * Ability to attend a minimum of 7 of 9 MBSR workshops Exclusion Criteria: * Peripheral vascular disease requiring revascularization of lower limb or amputation * Pregnant or lactating * Active alcohol or drug abuse/dependence * Previous MBSR training * Co-morbidity preventing assessment or understanding of questionnaires * Inability to speak English or French
Canadian sites (1)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02127762