NCT06171230

Eye Movement Desensitization and Reprocessing (EMDR) as a Treatment for Chronic Painful Diabetic Peripheral Neuropathy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Dijklander Ziekenhuis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study adopts a single-case experimental design, replicated nine times (N-of-1 study). Research on the effectiveness of EMDR therapy for neuropathic pain is limited to studies on phantom pain (and complex regional pain syndrome (CRPS). In the case of CRPS, two case reports are available, and for phantom pain, there is one RCT with 60 participants and three studies with 10 or fewer participants, without a control group. In the phantom pain studies, EMDR therapy focused on processing memories of events leading to the onset and exacerbation of pain (initial injury, amputation) and pain-related memories with current emotional charge. Sometimes, but not always, these events were life-threatening, as seen in PTSD (American Psychiatric Association Painful experiences, such as falling on the stump, or anticipated catastrophes (nightmares or disaster fantasies) with current emotional charge, were also processed. In the CRPS studies, EMDR therapy targeted traumatic events, including those from childhood, and pain-related events. In all studies, after the events were processed, pain itself was taken as the target for EMDR therapy. The studies demonstrate that after EMDR therapy, pain intensity decreases, as do comorbid symptoms. Research on the effectiveness of EMDR therapy as a treatment for chronic PDN, to the best of our knowledge, has not been conducted. The aim of the presented study is to investigate the effect of EMDR therapy on chronic PDN.

Conditions

• Neuropathic Pain
• Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	Eye Movement Desensitization and Reprocessing	Using the LEC and PCL-5, emotionally charged images are selected at the onset of the EMDR intervention. Initially, events meeting the criteria for PTSD (A-criterion worthy events) are processed. Subsequently, pain-related experiences, including any distressing images, are addressed. If the emotional charge of the events diminishes (SUD=0) before the completion of the six EMDR sessions, the participant is categorized as an 'early completer,' and the post-assessment is conducted immediately. The duration of each EMDR session is 90 minutes.
OTHER	Attention control phase	Prior to EMDR, there is a two-week attention control phase. During this phase, the participant is asked to daily record their activities, emotions, and thoughts when experiencing pain. This information is further explored and evaluated in two sessions lasting 45 minutes each, involving in-depth discussions with the participant.

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2023-12-14
• Last updated: 2024-03-12

Locations

1 site across 1 country: Netherlands