Back to resultsGraded Exposure in Patients With Painful Diabetic Neuropathy (PDN&GEXP)
Primary Purpose
Painful Diabetic Neuropathy, Diabetic Neuropathies, Painful, Neuralgia, Diabetic
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Graded Exposure
Sponsored by
About this trial
This is an interventional treatment trial for Painful Diabetic Neuropathy focused on measuring Graded Exposure, Quality of Life, Physical Activity, Anxiety
Eligibility Criteria
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).
Sites / Locations
- Maastricht University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single case study
Arm Description
Single case study using Graded exposure.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03066570
First Posted
February 6, 2017
Last Updated
December 1, 2020
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03066570
Brief Title
Graded Exposure in Patients With Painful Diabetic Neuropathy
Acronym
PDN&GEXP
Official Title
Graded Exposure in Patients With Painful Diabetic Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
March 18, 2019 (Actual)
Study Completion Date
March 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Painful Diabetic Neuropathy, Diabetic Neuropathies, Painful, Neuralgia, Diabetic
Keywords
Graded Exposure, Quality of Life, Physical Activity, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Randomized replicated sequential single-case design.
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single case study
Arm Type
Experimental
Arm Description
Single case study using Graded exposure.
Intervention Type
Behavioral
Intervention Name(s)
Graded Exposure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of Life as measured with Norfolk Quality of Life Questionnaire, Diabetic Neuropathy Version (Norfolk-QOL-DN)
Description
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.
Time Frame
The primary outcome measure will be measured after 8 weeks of treatment with GEXP.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotte Geelen, MD
Organizational Affiliation
charlotte.geelen@mumc.nl
Official's Role
Study Director
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229HX
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Graded Exposure in Patients With Painful Diabetic Neuropathy
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