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
• Status: Completed
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathies, Painful
• Neuralgia
• Neuralgia, Diabetic
• Pain
• Painful Diabetic Neuropathy
• Peripheral Nervous System Diseases

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.