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Graded Exposure in Patients With Painful Diabetic Neuropathy

NCT ID: NCT03066570

Last Updated: 2020-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2019-03-18

Brief Summary

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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

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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.

Conditions

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Painful Diabetic Neuropathy Diabetic Neuropathies, Painful Neuralgia, Diabetic

Keywords

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Graded Exposure Quality of Life Physical Activity Anxiety

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Randomized replicated sequential single-case design.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single case study

Single case study using Graded exposure.

Group Type EXPERIMENTAL

Graded Exposure

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charlotte Geelen, MD

Role: STUDY_DIRECTOR

[email protected]

Locations

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Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL 57919.068.16

Identifier Type: -

Identifier Source: org_study_id