Nerve pain in the feet caused by diabetes
Conditions
Interventions
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 i
period B). At 6-months after
baseline there will be a follow-up period of 2 weeks (FU
period C).
Period A (>3 weeks):
• 1x blood sample.
• 1x questionnaires.
• 10 days of accelerometry.
• Daily registration in diary.
Intervention: GEXP during 8 weeks
• 1x blood sample.
• 2x 1 hour
Chronic Pain
Painful Diabetic Neuropathy
Rehabilitation
Sponsors
Adelante Zorggroep
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Age > 18 years - Diabetes mellitus type II - Clinical neurological examination, CNE > 5 - Diabetic Neuropathy Symptom Score, DNS >= 1 - Douleur Neuropathique 4 Questions, DN4 >= 3
Exclusion criteria
Exclusion criteria: Patients with lower limb morbidities other than PDN such as peripheral arterial disease, severe osteoarthritis, any other neurological disease than PNP or any other disease that may cause pain in the feet and/or damage to the peripheral nervous system. Furthermore patients who have received any form of cognitive behavioural therapy in the last 6 months will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. To check whether the interventions modify pain-related fear, diabetes related fear, pain catastrophizing, pain experience patients fill in questions on an electronic diary. The daily measures consist of 1 question concerning pain intensity (VAS 0-10), 10 questions derived from the PART-Q30 questionnaire and 2 personalized open answer questions based on the Photograph-series Of Daily Activities (PHODA) and Canadian Occupational Performance Measure (COPM) taken at baseline. Physical activity and perceived activity decline: The level of activity will be determined using an accelerometer and a questionnaire consisting of two concepts: physical activity and perceived activity decline (PAD). Anamnestic physical activity will be measured using the Physical Activity Rating Scale (PARS). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Blood samples will be taken to assess glucose regulation. These samples include glucose, HbA1c and insulin (in order to calculate the HOMA2-IR score). All questionnaires are described in more detail in the research protocol. - Rehabilitation goals. The Canadian Occupational Performance Measure (COPM) will be used to assess perceived limitations in activities an participation and to aid the goal formulation process. - Disability. Disability will be measured using the Pain Disability Index (PDI). - Quality of Life. Quality of life (QoL) will be measured using the 33-item Norfolk Quality of Life Questionnaire, Diabetic Neuropathy Version (Norfolk-QOL-DN). - Overall PDN related fear will be measured using Painful Diabetic Neuropathy (PDN) Anxiety Rasch-Transformed 30-item questionnaire (PART-Q30). - Overall Anxiety and Depression will be measured using the Hospital Anxiety and Depression Scale (HADS). | — |
Countries
The Netherlands
Outcome results
None listed