Eye Movement Desensitization and Reprocessing (EMDR) as a Treatment for Chronic Painful Diabetic Peripheral Neuropathy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neuropathic Pain
- Sponsor
- Dijklander Ziekenhuis
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Pain intensity measured with the Numeric Rating Scale (NRS)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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:
- Does EMDR therapy significantly reduce pain intensity in individuals with chronic PDN?
- 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Pain intensity measured with the Numeric Rating Scale (NRS)
Time Frame: 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.)
The NRS is an 11-point numeric scale form 0 (no pain ) to 10 (worst pain)
Secondary Outcomes
- Pain Disability Index (PDI) Limitations in daily activities(The selected questions from the PDI are 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.))
- Quality of your sleep(Sleep problems are 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.))
- Anxiety(The anxiety level is assessed once daily in the evening for maximum of 154 days (throughout all phases of the study (phase A, phase B, phase C, post-assessment phase, and follow-up phase.))