Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617728
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Phantom Limb Pain in Amputees After the 2023 Türkiye Earthquake
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Beyond the Quake Exploring the Persistence of Phantom Limb Pain in Amputees from the 2023 Türkiye Earthquake
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to investigate the prevalence and persistence of phantom limb pain PLP among amputees who experienced limb loss due to injuries sustained during the 2023 Türkiye earthquake The main questions it aims to answer are
What is the prevalence of phantom limb pain among earthquake-related amputees at different follow-up intervals How do different pain management strategies such as regional analgesia versus intravenous analgesia affect the severity and persistence of phantom limb pain Researchers will compare participants receiving regional analgesia to those receiving intravenous analgesia to see if regional techniques are associated with lower rates of phantom limb pain and improved quality of life
Participants will
Complete pain assessments using standardized questionnaires at 1 week 3 months 6 months and 12 months post-amputation
Provide information on their pain management experiences and the impact on their daily activities
What is the prevalence of phantom limb pain among earthquake-related amputees at different follow-up intervals How do different pain management strategies such as regional analgesia versus intravenous analgesia affect the severity and persistence of phantom limb pain Researchers will compare participants receiving regional analgesia to those receiving intravenous analgesia to see if regional techniques are associated with lower rates of phantom limb pain and improved quality of life
Participants will
Complete pain assessments using standardized questionnaires at 1 week 3 months 6 months and 12 months post-amputation
Provide information on their pain management experiences and the impact on their daily activities
Detailed Description:
This observational study aims to assess the prevalence characteristics and management of phantom limb pain PLP among individuals who underwent amputations due to injuries sustained during the 2023 Türkiye earthquake Conducted at the Mersin University Pain Clinic the study involves 39 patients who were followed for 12 months post-amputation The primary focus is to evaluate how different analgesic methods such as regional versus intravenous analgesia influence the development and persistence of PLP and associated phantom limb sensations PLS
Patients were recruited from those treated at Mersin University Hospital immediately following the earthquake Inclusion criteria included individuals aged 5 years and older who experienced amputation due to earthquake-related trauma Exclusion criteria included pre-existing psychiatric disorders history of neuropathic pain in the amputated limb or inability to communicate due to cognitive impairment
The studys primary outcomes are the prevalence of PLP and PLS at 1 week 3 months 6 months and 12 months post-amputation Pain intensity is measured using the Visual Analog Scale VAS and the impact of different analgesic techniques on pain severity and quality of life is analyzed Secondary outcomes include the incidence of residual limb pain and the effectiveness of various pain management strategies in reducing pain symptoms over time
This study is expected to contribute valuable insights into the management of PLP in disaster-related amputees providing evidence to guide clinical practice and improve patient outcomes in similar post-disaster settings
Patients were recruited from those treated at Mersin University Hospital immediately following the earthquake Inclusion criteria included individuals aged 5 years and older who experienced amputation due to earthquake-related trauma Exclusion criteria included pre-existing psychiatric disorders history of neuropathic pain in the amputated limb or inability to communicate due to cognitive impairment
The studys primary outcomes are the prevalence of PLP and PLS at 1 week 3 months 6 months and 12 months post-amputation Pain intensity is measured using the Visual Analog Scale VAS and the impact of different analgesic techniques on pain severity and quality of life is analyzed Secondary outcomes include the incidence of residual limb pain and the effectiveness of various pain management strategies in reducing pain symptoms over time
This study is expected to contribute valuable insights into the management of PLP in disaster-related amputees providing evidence to guide clinical practice and improve patient outcomes in similar post-disaster settings
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None