Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06171230
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-11-28
Brief Title:
Eye Movement Desensitization and Reprocessing EMDR as a Treatment for Chronic Painful Diabetic Peripheral Neuropathy
Sponsor:
Dijklander Ziekenhuis
Organization:
Dijklander Ziekenhuis
Study Overview
Official Title:
Eye Movement Desensitization and Reprocessing EMDR as a Treatment for Chronic Painful Diabetic Peripheral Neuropathy
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMDR4CPDN
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
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None