Graded Exposure in Patients With Painful Diabetic Neuropathy (PDN&GEXP)

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Neuralgia, Diabetic; Painful Diabetic Neuropathy; Diabetic Neuropathies, Painful

Treatments: Behavioral: Graded Exposure

Study type: Interventional

Funder types: Other

Identifiers

NCT03066570

NL 57919.068.16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Single case study

Experimental group

Description:

Single case study using Graded exposure.

Treatment:

Behavioral: Graded Exposure