Eye Movement Desensitization and Reprocessing (EMDR) as a Treatment for Chronic Painful Diabetic … (NCT06171230) | Clinical Trial Compass
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Eye Movement Desensitization and Reprocessing (EMDR) as a Treatment for Chronic Painful Diabetic Peripheral Neuropathy
Netherlands10 participantsStarted 2024-03-01
Plain-language summary
The goal of this clinical trial is to investigate the effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) therapy in reducing pain intensity in individuals with chronic painful diabetic neuropathy (PDN). The main questions it aims to answer are:
1. Does EMDR therapy significantly reduce pain intensity in individuals with chronic PDN?
2. What is the impact of EMDR therapy on secondary outcomes, specifically anxiety, sleep disturbances, and personalized pain-related limitations? Additionally, the study will explore the correlation between pain scores and symptoms of post-traumatic stress disorder (PTSD) in individuals with chronic PDN.
Participants will undergo EMDR therapy sessions, focusing on the processing of emotionally charged pain-related events and addressing the pain itself. Main tasks for participants include active engagement in EMDR therapy sessions. Treatment outcomes, including changes in pain intensity, anxiety levels, sleep quality, and personalized pain-related limitations, will be monitored throughout the study.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Age: ≥ 18 years.
* Diagnosis of Diabetes Mellitus.
* Severity of pain in the past month, NRS-pain score ≥ 6.
* Ability to communicate in both written and spoken Dutch.
* Willingness to participate in the study (signed informed consent (IC)).
Exclusion criteria:
* Severe psychiatric disorders requiring immediate treatment.
* IQ \< 80.
* Initiation of medication within 3 months before the start of the study (medication in use for more than 3 months can be maintained; discontinuation of medication during the study is possible but not desirable).
* Concurrent psychotherapeutic treatment targeting neuropathic pain during the study.
* Substance abuse and/or dependence, unless medically prescribed.
* Inability to complete the questionnaires.
* Co-morbid conditions affecting the lower extremities, such as peripheral arterial disease, severe rheumatoid arthritis, osteoarthritis. Other conditions causing pain in the feet and/or damage to the peripheral nervous system, for example, ulcers.
* Co-morbid chronic pain syndromes.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain intensity measured with the Numeric Rating Scale (NRS)
Timeframe: Pain intensity is assessed once daily in the evening for a maximum of 154 days (throughout all phases of the study (phase A, phase B, phase C, post-assessment phase, and follow-up phase.)