The Effect of Mindfulness Based Stress Reduction in Patients With Painful Diabetic Peripheral Neuropathy

NCT02127762 | Completed

• 2 other identifiers: 20120541-01H# OG-2-12-3722-HN
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in pain-related disability, as measured by the Brief Pain Inventory. Pain interference scale at 3-month post-intervention.

  The primary outcome is pain-related disability, as measured by the Brief Pain Inventory pain interference scale which consists of 7 numerical scales (0 to10) rating pain interference with general activity, mood, walking ability, work, relations with other people, sleep and enjoyment of life.

  Baseline and 3 months post-intervention

Secondary Outcomes (13)

• Change from baseline in pain severity, as measured by the Brief Pain Inventory - Pain Severity scale, at 3 months post-intervention

  Baseline and 3 months post-intervention

• Change from baseline in mood states, as measured by the Profile of Mood States scale, at 3 months post-intervention.

  Baseline and 3 months post-intervention

• Overall change in status from baseline, as measured by Patient Global Impression of Change scale, at 3 months post-intervention.

  Baseline and 3 months post-intervention

• Change from baseline in stress, as measured by the Perceived Stress Scale, at 3 months post-intervention.

  Baseline and 3 months post-intervention

• Change from baseline in depressive symptoms, as measured by the Patient Health Questionnaire - 9 scale, at 3 months post-intervention

  Baseline and 3 months post-intervention

Study Arms (2)

Mindfulness Based Stress Reduction

EXPERIMENTAL

Participants assigned to this group will be enrolled in an Mindfulness-Based Stress Reduction (MBSR) program following medical treatment optimization. The MBSR program will be composed of eight weekly 2.5 hour sessions and one 6 hour session midway through the course.

Behavioral: Mindfulness Based Stress Reduction

Wait-listed Control Group

NO INTERVENTION

Participants assigned to this group after medical treatment optimization will act as wait-list controls for the MBSR group. They will be enrolled in the MBSR workshop 3 months after the corresponding intervention group completes the program.

Interventions

Mindfulness Based Stress Reduction BEHAVIORAL

Consists of eight weekly 2.5 hour sessions and one 6 hour session midway through the course. All sessions will be conducted by a psychologist or social worker with experience in chronic pain, formal MBSR training and 5 years of experience leading MBSR groups.

Mindfulness Based Stress Reduction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Diabetes Association: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (1)

• 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.

  PMID: 29263572 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Chronic Pain; Pain; Diabetic Neuropathies; Depression

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Howard Nathan, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: May 1, 2014
• Study Start: September 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: June 13, 2018

Record last verified: 2018-06

Locations

CA (1)