Phantom Limb Pain in Amputees After the 2023 Türkiye Earthquake

NCT06617728 | Completed

• 1 other identifier: TURK-PLP-2023
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Phantom Limb Pain; Amputation; Pain Management; Earthquake

Keywords

Phantom Limb Pain; Amputation; Earthquake Injuries; Türkiye Earthquake 2023

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Incidence of residual limb pain

  1 week, 3 months, 6 months, and 12 months

• o Impact of Analgesic Methods

  1 week, 3 months, 6 months, and 12 months

Study Arms (2)

Group 1: Regional Analgesia Cohort

Participants receiving regional analgesia for pain management.

Procedure: Intervention 1: Regional Analgesia

Group 2: Intravenous (IV) Analgesia Cohort

Participants receiving IV analgesia for pain management.

Drug: Intervention 2: Intravenous (IV) Analgesia

Interventions

Intervention 1: Regional Analgesia PROCEDURE

Regional analgesia techniques like epidural or peripheral nerve blocks.

Group 1: Regional Analgesia Cohort

Intervention 2: Intravenous (IV) Analgesia DRUG

IV medications used for pain control, including opioids and non-opioid analgesics.

Group 2: Intravenous (IV) Analgesia Cohort

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mesut Bakır: lead

Study Sites (1)

Mersin University Faculty of Medicine

Mersin, Yenişehir, 33133, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Phantom Limb; Agnosia

Interventions

Analgesia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Mesut Bakır, Assoc. Prof

  Mersin University Faculty of Medicine, Pain Clinic

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: September 27, 2024
• Study Start: February 6, 2023
• Primary Completion: April 30, 2024
• Study Completion: May 30, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available starting six months after publication of the primary results and for a period of five years.
• 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 \[mesutbakir@gmail.com\].

Locations

TU (1)