Graded Exposure in Patients With Painful Diabetic Neuropathy

Study Overview
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Brief Summary
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Objective: To investigate the effects of a cognitive behavioural intervention targeting specific fears in patients with painful diabetic neuropathy, on physical activity and quality of life.

Detailed Description
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Intervention: Graded Exposure in vivo (GEXP) is a second-generation cognitive-behavioural intervention, and is characterized by systematic and repeated exposure to feared movements, activities and/or sensations in order to decrease fear and subsequently increase physical activity. Main study parameters/endpoints: The purpose of this project is to develop and test a cognitive behavioural intervention targeting specific fears in patients with PDN, in order to increase physical activity and improve QOL.

Official Title
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Graded Exposure in Patients With Painful Diabetic Neuropathy

Conditions
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Painful Diabetic Neuropathy, Diabetic Neuropathies, Painful, Neuralgia, Diabetic

Intervention / Treatment
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* Behavioral: Graded Exposure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with type II diabetes mellitus, aged > 18 years who suffer from peripheral polyneuropathy. Exclusion Criteria: Patients with lower limb morbidities other than PDN such as peripheral arterial disease severe osteoarthritis, any other neurological disease than PDN or any other disease that may cause pain in the feet and/or damage to the peripheral nervous system (e.g. ulcers).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Interventional Model Description: Randomized replicated sequential single-case design.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single case study<br>Single case study using Graded exposure. | Behavioral: Graded Exposure<br>* Graded Exposure in vivo (GEXP) is a second-generation cognitive-behavioural intervention, and is characterized by systematic and repeated exposure to feared movements, activities and/or sensations in order to decrease fear and subsequently increase physical activity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life as measured with Norfolk Quality of Life Questionnaire, Diabetic Neuropathy Version (Norfolk-QOL-DN) | Quality of life (QOL) will be measured using the 33-item Norfolk Quality of Life Questionnaire, Diabetic Neuropathy Version (Norfolk-QOL-DN), a self-administered questionnaire designed to capture and quantify the perceived impact of diabetic neuropathy on the QOL, physical and psychosocial functioning of patients with diabetic neuropathy. | The primary outcome measure will be measured after 8 weeks of treatment with GEXP. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Graded Exposure, Quality of Life, Physical Activity, Anxiety