Phantom Limb PainNCT05005481
Incidence and Factors Affecting the Development and Outcome of Phantom Limb Pain (PLP) - A Single-centre Prospective Cohort Study.
An observational study of Phantom Limb Pain, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
Phantom limb pain (PLP), defined as pain felt in the missing portion of the amputated limb following amputation, occurs in a significant percentage of patients who undergo limb amputation and it is among the most difficult chronic pain syndromes to treat. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Phantom Limb Pain
- What is being tested?
- NIL intervention
- How many people
- 67 participants
- Where
- 1 siteSingapore
- Study dates
- 9 Aug 2021to 30 Jun 2022
- 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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients listed for limb amputation surgery will be recruited in the ward
Who may be able to join
- Age 21-80 years old
- Provided consent for the study
- Types of amputation surgery included: Forefoot amputation, below knee amputation, above knee amputation
Who cannot join
- Cognitive impairment/ uncommunicative patients
- Existing psychiatric condition
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital
Singapore, 169608
Zhen Wei LIM, MBBS, M MED, +6597807505, lim.zhen.wei@singhealth.com.sg
About this study
Phantom limb pain (PLP), defined as pain felt in the missing portion of the amputated limb following amputation, occurs in a significant percentage of patients who undergo limb amputation and it is among the most difficult chronic pain syndromes to treat. Its incidence has been reported to be around 70% though a local pilot study in 2013 reported the incidence to be 25%. The investigators aim to determine the actual incidence of PLP by conducting a single-centre prospective cohort study and identify risk factors associated with PLP. Subsequently, the investigators will use identified risk factors to develop and validate a risk prediction model for PLP after amputation surgery and design interventional studies aimed at reducing the development of PLP in high risk patients.
Read the detailed description
Specific aims:
By using prospective design and validated multidimensional pain questionnaire, the investigators aim to better estimate the true incidence of PLP, other associated risk factors and the severity of functional impairment.
This study is divided into 2 phases, of which the first phase of the study would be covered by the scope of the grant.
Phase 1 Primary Aim 1. To determine the local incidence of PLP at 3 months post amputation surgery (as literature suggests that PLP is most likely to develop within 3 months of amputation surgery) Hypothesis It is hypothesized that the incidence of PLP is estimated to be 41-85% from the literature .
Secondary Aims 1. Analyse and delineate modifiable and non-modifiable risk factors (patient, anaesthetic and surgical factors) contributing to the development of PLP. 2. Identify factors likely to prevent or reduce the development of PLP after amputation surgery 3. To identify factors prognosticating patient outcomes and recovery from PLP.
Phase 2 (out of the scope of the grant) Aims:
- To follow up patients prospectively to identify the long-term functional and psychological effects of PLP on patients
Background information:
According to International Association for the Study of Pain (IASP), Phantom limb pain (PLP) is defined as pain felt in the absent body part. PLP occurs in a significant percentage of patients who undergo limb amputation and it is among the most difficult chronic pain condition to treat. Undertreated PLP, together with other persistent chronic pain secondary to amputation can lead to limitations in both physical and psychosocial function and impair their rehabilitation.
The true prevalence of PLP among people with amputation is unclear, especially among Asian population. There are various reports of PLP prevalence ranging from 40% to 80% depending on the site of amputation, the patient population, and the time since amputation.
The exact reason why some patients develop phantom pain after amputation is still unknown. The development of PLP is likely multifactorial and includes peripheral, central, and psychological factors. Several risk factors associated with the development of PLP have been identified in various studies but the overall results are rather conflicting. Risk factors such as persisting pre-operative pain, stump pain, patient comorbidity contribute to the onset of PLP. The majority of these studies, however, are based on Caucasian population.
Nevertheless, it is increasingly clear that patients with PLP will continue to rise locally in view of higher prevalence of Diabetes Mellitus and malignancy, largely attributed to ageing population. In Singapore, major lower extremity amputation rate has increased from 11.0 per 100,000 population in 2008 to 13.3 per 100,000 population in 2013. It was reported in 2001 that approximately 700 lower extremity amputation (LEA) were performed in patients with diabetes annually. The figures more than doubled to 1500 LEA annually in 2017, due to complications arising from diabetes.
Despite anticipating PLP to be a significant burgeoning healthcare burden, PLP is underreported and undertreated, leading to poor rehabilitation outcome. There is also a paucity on local data, with only one ever publication related to PLP in Singapore. The lack of local data in terms of definitive incidence estimate in our population, the functional impairment from PLP and potential risk factors has greatly hindered the development or implementation of effective interventions for preventing or treating PLP. Thus, the primary aim of this study is to establish the incidence of PLP in our local population, the risk factors associated with PLP and its functional impact.
- Conditions
- Phantom Limb Pain
- Being tested
- NIL intervention
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIL interventionOther
NIL intervention will be performed on patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Phantom Limb Pain
Phantom Limb Pain
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start9 Aug 2021
- Primary completion9 Apr 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
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.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- 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
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Diana Chan Xin Hui, Lin Xufeng, Yap Haoyun
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005481
- Sponsor's protocol ID
- 2021/2456
- Status last verified
- Sep 2021
- First submitted
- 5 Aug 2021
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share data with other institution
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Factors Affecting the Development and Outcome of Phantom Limb Pain (PLP) - A Single-centre Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT05005481
- Acronym / sponsor ID
- 2021/2456
- Conditions
- Phantom Limb Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Diana Chan Xin Hui, Lin Xufeng, Yap Haoyun
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 9 Apr 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 13 Aug 2021 (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.
Phantom limb pain (PLP), defined as pain felt in the missing portion of the amputated limb following amputation, occurs in a significant percentage of patients who undergo limb amputation and it is among the most difficult chronic pain syndromes to treat. Its incidence has been reported to be around 70% though a local pilot study in 2013 reported the incidence to be 25%. The investigators aim to determine the actual incidence of PLP by conducting a single-centre prospective cohort study and identify risk factors associated with PLP. Subsequently, the investigators will use identified risk factors to develop and validate a risk prediction model for PLP after amputation surgery and design interventional studies aimed at reducing the development of PLP in high risk patients.
Detailed description
Specific aims:
By using prospective design and validated multidimensional pain questionnaire, the investigators aim to better estimate the true incidence of PLP, other associated risk factors and the severity of functional impairment.
This study is divided into 2 phases, of which the first phase of the study would be covered by the scope of the grant.
Phase 1 Primary Aim 1. To determine the local incidence of PLP at 3 months post amputation surgery (as literature suggests that PLP is most likely to develop within 3 months of amputation surgery) Hypothesis It is hypothesized that the incidence of PLP is estimated to be 41-85% from the literature .
Secondary Aims 1. Analyse and delineate modifiable and non-modifiable risk factors (patient, anaesthetic and surgical factors) contributing to the development of PLP. 2. Identify factors likely to prevent or reduce the development of PLP after amputation surgery 3. To identify factors prognosticating patient outcomes and recovery from PLP.
Phase 2 (out of the scope of the grant) Aims:
- To follow up patients prospectively to identify the long-term functional and psychological effects of PLP on patients
Background information:
According to International Association for the Study of Pain (IASP), Phantom limb pain (PLP) is defined as pain felt in the absent body part. PLP occurs in a significant percentage of patients who undergo limb amputation and it is among the most difficult chronic pain condition to treat. Undertreated PLP, together with other persistent chronic pain secondary to amputation can lead to limitations in both physical and psychosocial function and impair their rehabilitation.
The true prevalence of PLP among people with amputation is unclear, especially among Asian population. There are various reports of PLP prevalence ranging from 40% to 80% depending on the site of amputation, the patient population, and the time since amputation.
The exact reason why some patients develop phantom pain after amputation is still unknown. The development of PLP is likely multifactorial and includes peripheral, central, and psychological factors. Several risk factors associated with the development of PLP have been identified in various studies but the overall results are rather conflicting. Risk factors such as persisting pre-operative pain, stump pain, patient comorbidity contribute to the onset of PLP. The majority of these studies, however, are based on Caucasian population.
Nevertheless, it is increasingly clear that patients with PLP will continue to rise locally in view of higher prevalence of Diabetes Mellitus and malignancy, largely attributed to ageing population. In Singapore, major lower extremity amputation rate has increased from 11.0 per 100,000 population in 2008 to 13.3 per 100,000 population in 2013. It was reported in 2001 that approximately 700 lower extremity amputation (LEA) were performed in patients with diabetes annually. The figures more than doubled to 1500 LEA annually in 2017, due to complications arising from diabetes.
Despite anticipating PLP to be a significant burgeoning healthcare burden, PLP is underreported and undertreated, leading to poor rehabilitation outcome. There is also a paucity on local data, with only one ever publication related to PLP in Singapore. The lack of local data in terms of definitive incidence estimate in our population, the functional impairment from PLP and potential risk factors has greatly hindered the development or implementation of effective interventions for preventing or treating PLP. Thus, the primary aim of this study is to establish the incidence of PLP in our local population, the risk factors associated with PLP and its functional impact.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients listed for limb amputation surgery will be recruited in the ward
Key inclusion criteria (3 listed)
- Age 21-80 years old
- Provided consent for the study
- Types of amputation surgery included: Forefoot amputation, below knee amputation, above knee amputation
Key exclusion criteria (2 listed)
- Cognitive impairment/ uncommunicative patients
- Existing psychiatric condition
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 |
|---|---|---|
| NIL interventionNIL intervention will be performed on patients. | Other | – |
Primary outcome
Incidence of Phantom Limb Pain
Time frame: 3 months
Phantom Limb Pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Individual participant dataSharing planned: No. No plan to share data with other institution
Related trials for Phantom Limb Pain
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Uses of Phantom Sensations Induced by Global and Local Modifications of the Prosthetic Socket as Somatosensory Feedback During Walking in Lower Limb Amputees
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Recruiting
TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
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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.
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, run by Singapore General Hospital at 1 site in Singapore.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Oct 2021. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhen Wei LIM, M Med (+65 97807505, lim.zhen.wei@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Phantom Limb Pain (time frame: 3 months). 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 4 Oct 2021.