Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-31 @ 12:04 PM
Study NCT ID:
NCT06617728
Status:
COMPLETED
Last Update Posted:
2024-10-01
First Post:
2024-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phantom Limb Pain in Amputees After the 2023 Türkiye Earthquake
Sponsor:
Mesut Bakır
Organization:
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:
False
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 study's 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 study's 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:
False
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?:
False
Is an FDA AA801 Violation?: