Clinical trial NCT06617728: Phantom Limb Pain in Amputees After the 2023 Türkiye Earthquake
Official title: Beyond the Quake: Exploring the Persistence of Phantom Limb Pain in Amputees from the 2023 Türkiye Earthquake
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Phantom Limb Pain
Amputation
Pain Management
Earthquake
Keywords: Phantom Limb Pain
Amputation
Earthquake Injuries
Türkiye Earthquake 2023
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 39
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of phantom limb pain
timeFrame: 1 week, 3 months, 6 months, and 12 months
measure: o Prevalence of phantom limb sensations
timeFrame: 1 week, 3 months, 6 months, and 12 months
Secondary outcomes:
measure: Incidence of residual limb pain
timeFrame: 1 week, 3 months, 6 months, and 12 months
measure: o Impact of Analgesic Methods
timeFrame: 1 week, 3 months, 6 months, and 12 months
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin University Faculty of Medicine
state: Yenişehir
Study officials:
affiliation: Mersin University Faculty of Medicine, Pain Clinic
name: Mesut Bakır, Assoc. Prof
role: STUDY_CHAIR
References: