Phantom Limb Pain in Amputees After the 2023 Türkiye Earthquake

Beyond the Quake: Exploring the Persistence of Phantom Limb Pain in Amputees from the 2023 Türkiye Earthquake

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.

Study Overview

• Status: Completed
• Conditions: Amputation; Pain Management; Phantom Limb Pain; Earthquake
• Intervention / Treatment: Procedure: Intervention 1: Regional Analgesia; Drug: Intervention 2: Intravenous (IV) Analgesia

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.

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• Turkey
  • Yenişehir
    • Mersin, Yenişehir, Turkey, 33133
      • Mersin University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of individuals who underwent amputations due to injuries sustained during the 2023 Türkiye earthquake. These patients were treated at the Pain Clinic of Mersin University Hospital and include both males and females aged 5 years and older. The study focuses on patients experiencing phantom limb pain (PLP) following amputation and evaluates the impact of different pain management strategies on their pain outcomes and quality of life. Participants include a diverse group with varying levels of amputation and injury severity, providing a comprehensive understanding of PLP in a post-disaster context.

Description

Inclusion Criteria:

• Individuals aged 5 years and older.
• Patients who have undergone amputation due to injuries sustained during the 2023 Türkiye earthquake.
• Experiencing phantom limb pain (PLP) as confirmed by a structured questionnaire.
• Able to provide informed consent or have consent provided by a legal guardian if under the age of 18.

Exclusion Criteria:

• Pre-existing psychiatric disorders that could interfere with pain perception or reporting.
• History of neuropathic pain in the amputated limb prior to the earthquake.
• Underwent surgical interventions in other parts of the body that may affect pain assessment.
• Inability to communicate effectively due to cognitive impairment or other medical conditions.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1: Regional Analgesia Cohort; Participants receiving regional analgesia for pain management.	Procedure: Intervention 1: Regional Analgesia; Regional analgesia techniques like epidural or peripheral nerve blocks.
Group 2: Intravenous (IV) Analgesia Cohort; Participants receiving IV analgesia for pain management.	Drug: Intervention 2: Intravenous (IV) Analgesia; IV medications used for pain control, including opioids and non-opioid analgesics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of phantom limb pain	The percentage of amputee patients reporting PLP at each follow-up interval. PLP will be categorized as mild, moderate, or severe based on VAS scores.	1 week, 3 months, 6 months, and 12 months
o Prevalence of phantom limb sensations	The frequency of non-painful PLS such as tingling, itching, or movement sensations reported by patients at each follow-up period	1 week, 3 months, 6 months, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of residual limb pain	The number of patients reporting RLP at each follow-up interval, categorized based on VAS scores.	1 week, 3 months, 6 months, and 12 months
o Impact of Analgesic Methods	The effect of different analgesic methods on the prevalence and severity of PLP and PLS. Outcomes will be analyzed to determine which analgesic method is associated with lower pain scores and fewer phantom sensations.	1 week, 3 months, 6 months, and 12 months

Collaborators and Investigators

• Sponsor: Mesut Bakır
• Investigators: Study Chair: Mesut Bakır, Assoc. Prof, Mersin University Faculty of Medicine, Pain Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2023
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: September 26, 2024
• First Posted (Actual): September 27, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 27, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Amputation; Phantom Limb Pain; Earthquake Injuries; Türkiye Earthquake 2023
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Pain, Postoperative; Phantom Limb
• Other Study ID Numbers: TURK-PLP-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified participant data will be shared upon reasonable request. Data will include demographic information, clinical outcomes, and responses to pain assessments. Researchers can request access by contacting the Principal Investigator at [mesutbakir@gmail.com]. Data will be available starting six months after publication of the primary results and for a period of five years.
• IPD Sharing Time Frame: Data will be available starting six months after publication of the primary results and for a period of five years.
• IPD Sharing Access Criteria: De-identified participant data will be shared upon reasonable request. Data will include demographic information, clinical outcomes, and responses to pain assessments. Researchers can request access by contacting the Principal Investigator at [mesutbakir@gmail.com].
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No