Graded Exposure in Patients With Painful Diabetic Neuropathy

NCT03066570 | Completed

• 1 other identifier: NL 57919.068.16
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Painful Diabetic Neuropathy; Diabetic Neuropathies, Painful; Neuralgia, Diabetic

Keywords

Graded Exposure; Quality of Life; Physical Activity; Anxiety

Outcome Measures

Primary Outcomes (1)

• Quality of Life as measured with Norfolk Quality of Life Questionnaire, Diabetic Neuropathy Version (Norfolk-QOL-DN)

  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.

  The primary outcome measure will be measured after 8 weeks of treatment with GEXP.

Study Arms (1)

Single case study

EXPERIMENTAL

Single case study using Graded exposure.

Behavioral: Graded Exposure

Interventions

Graded Exposure 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.

Single case study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with type II diabetes mellitus,
• aged \> 18 years who suffer from peripheral polyneuropathy.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229HX, Netherlands

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Motor Activity; Anxiety Disorders

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Behavior; Mental Disorders

Study Officials

• Charlotte Geelen, MD

  charlotte.geelen@mumc.nl

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized replicated sequential single-case design.

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: February 28, 2017
• Study Start: June 1, 2017
• Primary Completion: March 18, 2019
• Study Completion: March 18, 2019
• Last Updated: December 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)