Graded Exposure in Patients With Painful Diabetic Neuropathy

Not Applicable

Completed

• Conditions: Painful Diabetic Neuropathy; Diabetic Neuropathies, Painful; Neuralgia, Diabetic
• Interventions: Behavioral: Graded Exposure

• Registration Number: NCT03066570
• Lead Sponsor: Maastricht University Medical Center

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.

Study Timeline

• Study First Submitted: 2017-02-06
• Study First Submitted QC: 2017-02-23
• Study First Posted: 2017-02-28
• Study Start: 2017-06-01
• Primary Completion: 2019-03-18
• Study Completion: 2019-03-18
• Status Verified: 2020-11
• Last Update Submitted: 2020-12-01
• Last Update Posted: 2020-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Single case study	Graded Exposure	Single case study using Graded exposure.

Primary Outcome Measures

Name	Time	Method
Quality of Life as measured with Norfolk Quality of Life Questionnaire, Diabetic Neuropathy Version (Norfolk-QOL-DN)	The primary outcome measure will be measured after 8 weeks of treatment with GEXP.	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.

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands