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NCT Number: NCT06617728

Phantom Limb Pain in Amputees After 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.

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Key information

Conditions

Phantom Limb Pain Agnosia Amputation Earthquake Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain Management Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Phantom Limb Postoperative Complications Signs and Symptoms

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mersin University Faculty of Medicine

Mersin, Yenişehir, 33133, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention 1: Regional Analgesia

Procedure

Regional analgesia techniques like epidural or peripheral nerve blocks.

Intervention 2: Intravenous (IV) Analgesia

Drug

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

Primary outcomes

  1. Prevalence of phantom limb pain

    Time frame: 1 week, 3 months, 6 months, and 12 months

    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.

  2. o Prevalence of phantom limb sensations

    Time frame: 1 week, 3 months, 6 months, and 12 months

    The frequency of non-painful PLS such as tingling, itching, or movement sensations reported by patients at each follow-up period

Secondary outcomes

  1. Incidence of residual limb pain

    Time frame: 1 week, 3 months, 6 months, and 12 months

    The number of patients reporting RLP at each follow-up interval, categorized based on VAS scores.

  2. o Impact of Analgesic Methods

    Time frame: 1 week, 3 months, 6 months, and 12 months

    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.

Sponsors and collaborators

Lead sponsor

Mesut Bakır

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 27, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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