Diabetic Neuropathies, Painful, Neuralgia, Diabetic, Painful Diabetic Neuropathy
Conditions
Keywords
Graded Exposure, Quality of Life, Physical Activity, Anxiety
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.
Interventions
BEHAVIORALGraded 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.
Sponsors
Maastricht University Medical Center
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized replicated sequential single-case design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Netherlands
Outcome results
None listed