Phantom Limb PainNCT06617728
Phantom Limb Pain in Amputees After the 2023 Türkiye Earthquake
An observational study of Phantom Limb Pain and Amputation, run by Mesut Bakır at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Phantom Limb Pain, Amputation, Pain Management
- What is being tested?
- Intervention 1: Regional Analgesia and Intervention 2: Intravenous (IV) Analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Feb 2023to 30 May 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mersin University Faculty of Medicine
Mersin, Yenişehir, 33133
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Phantom Limb Pain, Amputation, Pain Management, Earthquake
- Being tested
- Intervention 1: Regional Analgesia, Intervention 2: Intravenous (IV) Analgesia
- Keywords
- Phantom Limb Pain, Amputation, Earthquake Injuries, Türkiye Earthquake 2023
- Medical subject headings
- Phantom Limb, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1: Regional AnalgesiaProcedure or surgery
Regional analgesia techniques like epidural or peripheral nerve blocks.
Intervention 2: Intravenous (IV) AnalgesiaDrug
IV medications used for pain control, including opioids and non-opioid analgesics.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Regional Analgesia Cohort | Participants receiving regional analgesia for pain management. Receives: Procedure: Intervention 1: Regional Analgesia | |
| Group 2: Intravenous (IV) Analgesia Cohort | Participants receiving IV analgesia for pain management. Receives: Drug: Intervention 2: Intravenous (IV) Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 1 week, 3 months, 6 months, and 12 months
Secondary outcomes (2)
Incidence of residual limb pain
The number of patients reporting RLP at each follow-up interval, categorized based on VAS scores.
Measured: 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.
Measured: 1 week, 3 months, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start6 Feb 2023
- Primary completion30 Apr 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phantom Limb PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Mesut Bakır
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mesut Bakır, Mersin University
- Investigators
- Mesut Bakır, Assoc. Prof, Study chair, Mersin University Faculty of Medicine, Pain Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617728
- Sponsor's protocol ID
- TURK-PLP-2023
- Status last verified
- Sep 2024
- First submitted
- 26 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond the Quake: Exploring the Persistence of Phantom Limb Pain in Amputees from the 2023 Türkiye Earthquake
- ClinicalTrials.gov ID
- NCT06617728
- Acronym / sponsor ID
- TURK-PLP-2023
- Conditions
- Phantom Limb Pain, Amputation, Pain Management, Earthquake
- Keywords
- Phantom Limb Pain, Amputation, Earthquake Injuries, Türkiye Earthquake 2023
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Mesut BakırUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Regional Analgesia Cohort | – | Procedure: Intervention 1: Regional AnalgesiaParticipants receiving regional analgesia for pain management. |
| Group 2: Intravenous (IV) Analgesia Cohort | – | Drug: Intervention 2: Intravenous (IV) AnalgesiaParticipants receiving IV analgesia for pain management. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention 1: Regional AnalgesiaRegional analgesia techniques like epidural or peripheral nerve blocks. | Procedure or surgery | Group 1: Regional Analgesia Cohort |
| Intervention 2: Intravenous (IV) AnalgesiaIV medications used for pain control, including opioids and non-opioid analgesics. | Drug | Group 2: Intravenous (IV) Analgesia Cohort |
Primary outcome
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.
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
2 secondary outcomes
Incidence of residual limb pain
Time frame: 1 week, 3 months, 6 months, and 12 months
o Impact of Analgesic Methods
Time frame: 1 week, 3 months, 6 months, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mesut Bakır, Assoc. Prof study chair
Mersin University Faculty of Medicine, Pain Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Phantom Limb Pain and Amputation, run by Mesut Bakır at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of phantom limb pain (time frame: 1 week, 3 months, 6 months, and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.