Clinical trial NCT02127762: The Effect of Mindfulness Based Stress Reduction in Patients With Painful Diabetic Peripheral Neuropathy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Type I Diabetes
Type II Diabetes
Diabetic Peripheral Neuropathy
Chronic Pain
Keywords: Pain
Quality of Life
Glycemic Control
diabetic neuropathy
mindfulness
stress reduction
adult
chronic pain
depression
cortisol
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Diabetes Association
First posted: 2014-05-01
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: The investigators will recruit 110 adults with painful diabetic peripheral neuropathy. All will have their medical treatment optimized by a pain medicine specialist before being randomly assigned to either an 8-week group MBSR program or a wait-list. All participants will complete self-report questionnaires, provide a hair sample for cortisol measurements and a blood sample to measure glycemic index. We will be collecting outcome data for both groups. Patients randomized to MBSR will have data collected at 4 time points: 1) before medical optimization; 2) after medical optimization and before the MBSR group intervention begins, 3) 2 weeks after the group intervention; and 4) 3 months following completion of MBSR. Patients randomized to control will have data collected at 6-7 time points depending on when are participants enrolled in the trial: 1) before medical optimization; 2) after medical optimization and before the MBSR group intervention begins; 3) 2 weeks after the group intervention; 4) 3 months following completion of MBSR; 5) Re-test before control group intervention begins; 6) 2 weeks after control group intervention; and 7) 3 months after control group intervention.

The primary hypothesis is that after all patients are medically optimized, those randomized to MBSR will have a 30% higher incidence of clinically significant (≥1.0 decrease in mean BPI interference score) improvement (responders) compared to controls measured 3 months following completion of MBSR. A significant change is defined as ≥ 1 decrease in BPI interference score. A one point change on the Interference Scale, has been recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) group as a minimally clinically important change. This design controls for the effect of time and disease fluctuation, regression to the mean, and the effect of testing. In this preliminary research, where our primary goal is to establish proof of concept and obtain data needed to plan a comparative trial, we are not controlling for the placebo effect. We believe that a wait-list controlled study is the necessary foundation on which to build a rigorous program of research.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in pain-related disability, as measured by the Brief Pain Inventory. Pain interference scale at 3-month post-intervention.
timeFrame: Baseline and 3 months post-intervention
Secondary outcomes:
measure: Change from baseline in pain severity, as measured by the Brief Pain Inventory - Pain Severity scale, at 3 months post-intervention
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline in mood states, as measured by the Profile of Mood States scale, at 3 months post-intervention.
timeFrame: Baseline and 3 months post-intervention
measure: Overall change in status from baseline, as measured by Patient Global Impression of Change scale, at 3 months post-intervention.
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline in stress, as measured by the Perceived Stress Scale, at 3 months post-intervention.
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline in depressive symptoms, as measured by the Patient Health Questionnaire - 9 scale, at 3 months post-intervention
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline in pain catastrophizing, as measured by the Pain Catastrophizing Scale, at 3 months post-intervention.
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline in mindfulness, as measured by the Five Facet Mindfulness Questionnaire, at 3 months post-intervention.
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline in quality of life, as measured by the Short-Form-12 Health Survey, at 3 months post-intervention.
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline in quality of life, as measured by the Neuropathy-Specific Quality of Life Questionnaire (NeuroQOL).
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline in quality of health and life, as measured by the The Summary of Diabetes Self-Care Activities (SDSCA).
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline in adverse reactions as a result of their glycemic control, as measured by the Blood Sugar Reactions Questionnaire.
timeFrame: Baseline and 3 months post-intervention
measure: Change from pre-intervention in biomarkers of stress, as measured by hair cortisol levels, at 3 months post-intervention.
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline in glycemic control, as measured by blood levels of Hemoglobin A1c.
timeFrame: Baseline and 3 months post-intervention
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Howard Nathan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nathan HJ, Poulin P, Wozny D, Taljaard M, Smyth C, Gilron I, Sorisky A, Lochnan H, Shergill Y. Randomized Trial of the Effect of Mindfulness-Based Stress Reduction on Pain-Related Disability, Pain Intensity, Health-Related Quality of Life, and A1C in Patients With Painful Diabetic Peripheral Neuropathy. Clin Diabetes. 2017 Dec;35(5):294-304. doi: 10.2337/cd17-0077.