Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05005481 |
| Other study ID # |
2021/2456 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 9, 2021 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
September 2021 |
| Source |
Singapore General Hospital |
| Contact |
Zhen Wei LIM, M Med |
| Phone |
+65 97807505 |
| Email |
lim.zhen.wei[@]singhealth.com.sg |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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:
1. 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.
