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

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ClinicalTrials.gov Identifier: NCT03066570
Recruitment Status : Recruiting
First Posted : February 28, 2017
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Painful Diabetic Neuropathy Diabetic Neuropathies, Painful Neuralgia, Diabetic Behavioral: Graded Exposure Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Randomized replicated sequential single-case design.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Graded Exposure in Patients With Painful Diabetic Neuropathy
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single case study
Single case study using Graded exposure.
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.




Primary Outcome Measures :
  1. Quality of Life as measured with Norfolk Quality of Life Questionnaire, Diabetic Neuropathy Version (Norfolk-QOL-DN) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066570


Contacts
Contact: Charlotte Geelen, MD +31433876543 charlotte.geelen@mumc.nl

Locations
Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Limburg, Netherlands, 6229HX
Contact: Charlotte Geelen, MD         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Study Director: Charlotte Geelen, MD charlotte.geelen@mumc.nl

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03066570     History of Changes
Other Study ID Numbers: NL 57919.068.16
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maastricht University Medical Center:
Graded Exposure
Quality of Life
Physical Activity
Anxiety

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Pain
Neuralgia
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases