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NCT03066570 Clinical Trial

Graded Exposure in Patients With Painful Diabetic Neuropathy

Painful Diabetic Neuropathy Clinical Trial

— PDN&GEXP  

Official title:
Graded Exposure in Patients With Painful Diabetic Neuropathy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03066570
Other study ID # NL 57919.068.16
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2017
Est. completion date March 18, 2019

Study information
Verified date November 2020
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date March 18, 2019
Est. primary completion date March 18, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Graded Exposure
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.

Locations
Country Name City State
Netherlands Maastricht University Medical Center Maastricht Limburg

Sponsors (1)
Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.
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