Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398132
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-24
Brief Title:
Understanding and Managing Pain for Thalidomide Survivors
Sponsor:
University of Nottingham
Organization:
University of Nottingham
Study Overview
Official Title:
Thalidomide-Related Investigation on Understanding and Managing Pain for Thalidomide Survivors
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRIUMPH-TS
Brief Summary:
Aim To explore the pain experience of Thalidomide survivors and propose an effective pain management service tailored to meet the unique needs of this population
Background Approximately 400 thalidomide survivors live in the UK who are also beneficiaries of the Thalidomide Trust Such individuals have been mainly born with upper or lower limb problems but some also experience sight hearing or speaking difficulties Most tend to experience additional problems acquired after birth including persistent muscle or joint pain as well as mental health problems Such conditions may reduce the quality of life of thalidomide survivors who face significant difficulties in accessing healthcare services or receiving effective treatment Specialist services such as pain management are not easily available to thalidomide survivors Providers lack of understanding or flexibility to treat populations with unique needs and geographical or financial barriers have been considered as possible reasons
Methods This is a cross-sectional observational study Thalidomide survivors who are also beneficiaries of the Thalidomide Trust will be offered a questionnaire booklet to fill featuring questionnaires aiming to explore their pain experience 0-10 Pain Numerical Rating Scale Central Aspects of Pain painDETECT Widespread Pain Index mental health Hospital Anxiety and Depression Scale beliefs Pain Catastrophizing Tampa Scale of Kinesiophobia quality of life EQ-5D-5L disability Health Assessment Questionnaire sleep Athens Insomnia Scale and medicines use Pain Medication Attitude Questionnaire Linear regression modelling will explore the factors that best explain the overall pain experience of Thalidomide Survivors
Impact The research will inform how thalidomide survivors might gain access to an evidence-based pain management service designed specifically for them which will improve their quality of life
Background Approximately 400 thalidomide survivors live in the UK who are also beneficiaries of the Thalidomide Trust Such individuals have been mainly born with upper or lower limb problems but some also experience sight hearing or speaking difficulties Most tend to experience additional problems acquired after birth including persistent muscle or joint pain as well as mental health problems Such conditions may reduce the quality of life of thalidomide survivors who face significant difficulties in accessing healthcare services or receiving effective treatment Specialist services such as pain management are not easily available to thalidomide survivors Providers lack of understanding or flexibility to treat populations with unique needs and geographical or financial barriers have been considered as possible reasons
Methods This is a cross-sectional observational study Thalidomide survivors who are also beneficiaries of the Thalidomide Trust will be offered a questionnaire booklet to fill featuring questionnaires aiming to explore their pain experience 0-10 Pain Numerical Rating Scale Central Aspects of Pain painDETECT Widespread Pain Index mental health Hospital Anxiety and Depression Scale beliefs Pain Catastrophizing Tampa Scale of Kinesiophobia quality of life EQ-5D-5L disability Health Assessment Questionnaire sleep Athens Insomnia Scale and medicines use Pain Medication Attitude Questionnaire Linear regression modelling will explore the factors that best explain the overall pain experience of Thalidomide Survivors
Impact The research will inform how thalidomide survivors might gain access to an evidence-based pain management service designed specifically for them which will improve their quality of life
Detailed Description:
Between 1958 and 1961 Thalidomide was widely prescribed in the UK as a safe non-addictive sedative and tranquiliser Despite being marketed as an entirely safe treatment for the discomforts of pregnancy including morning sickness Thalidomide caused serious damage to the unborn child when taken during the first trimester Foetal damage typically included upper andor lower limb malformation total limb absence missing bones etc eye ear and facial damage damaged ears narrow ear canals small or damaged eyes restricted eye movement and facial palsy and malformation of internal organs heart urinary and alimentary tracts and reproductive organs Collectively such birth defects are referred to as Thalidomide Embryopathy or Thalidomide Syndrome A charitable trust - the Thalidomide Childrens Trust now the Thalidomide Trust was established to oversee compensation payments from Distillers to those children affected by Thalidomide in the UK
Thalidomide survivors experience significantly worse physical and mental health than the general population of the same age demonstrating a wide range of secondary health problems in particular chronic musculoskeletal pain which is the most reported symptom as well as movement restrictions and mental disorders Such health problems impair the ability of these individuals to remain fully independent and negatively impact on their health-related quality of life as they limit their overall ability to adopt an active lifestyle and engage or access potentially beneficial treatments
Thalidomide survivors form a unique underrepresented and disadvantaged group of people who must overcome a number of additional barriers in order to receive appropriate care Compared with non-Thalidomide age-matched populations Thalidomide survivors demonstrate higher prevalence of pain and disability However most comparisons have been done with members of the general population Thalidomide Trust beneficiaries with lived experience of chronic pain might share features with other populations with chronic musculoskeletal pain eg Fibromyalgia Rheumatoid Arthritis Chronic Low Back Pain such as reluctance to take tablets due to their formative experience with medicines poor experiences from exposure to multiple interventions and surgeries and difficult experiences with health care professionals who seem not to understand or often dismiss their unique and complex needs Despite the prevalence of shared features Thalidomide survivors might also experience unique issues that are not shared with other populations with chronic pain Whilst effective pain management has become more accessible to some populations with chronic musculoskeletal pain for Thalidomide survivors inequity persists Novel research investigating the lived experience of pain by Thalidomide survivors is needed explore potential barriers in pain management of Thalidomide Survivors
To address this gap in literature the project aims to define the pain experience of beneficiaries This cross-sectional observational study entails a questionnaire booklet designed to collect numerical and categorical data about the experience of pain by Thalidomide survivors as well as the impact of pain on their lives and overall wellbeing To ensure that participants adequately represent Thalidomide survivors as a unique population a purposive sampling strategy will be followed
Distinct categories of pain have been identified in the general population such as neuropathic pain nociplastic pain or chronic primary pain The project will quantitatively via collection of new primary data explore whether these categories can be also identified in Thalidomide survivors whether one or more category is more common than others and whether there is a unique Thalidomide pain category A combination of different sets of criteria developed by the International Association for the Study of Pain IASP and patient reported outcome measures namely Central Aspects of Pain CAP and painDETECT will be used for categorising
All beneficiaries of the Thalidomide Trust can potentially be recruited n400 However past pain-related research exploring combinations of biopsychosocial variables and pain intensity 2 has shown that with estimated variation of 40 R2040 and an estimated number of independent variables 5 to 7 to be included in regression analyses 120 individuals are considered sufficient to power the study and explain 38-49 of the variance in the regression model Calculations are based on the estimated squared multiple correlation-coefficient R2 10
Regression analyses will explore whether certain factors potentially identified also as barriers in the qualitative aspect of the WP are associated with the experience of pain
Thalidomide survivors experience significantly worse physical and mental health than the general population of the same age demonstrating a wide range of secondary health problems in particular chronic musculoskeletal pain which is the most reported symptom as well as movement restrictions and mental disorders Such health problems impair the ability of these individuals to remain fully independent and negatively impact on their health-related quality of life as they limit their overall ability to adopt an active lifestyle and engage or access potentially beneficial treatments
Thalidomide survivors form a unique underrepresented and disadvantaged group of people who must overcome a number of additional barriers in order to receive appropriate care Compared with non-Thalidomide age-matched populations Thalidomide survivors demonstrate higher prevalence of pain and disability However most comparisons have been done with members of the general population Thalidomide Trust beneficiaries with lived experience of chronic pain might share features with other populations with chronic musculoskeletal pain eg Fibromyalgia Rheumatoid Arthritis Chronic Low Back Pain such as reluctance to take tablets due to their formative experience with medicines poor experiences from exposure to multiple interventions and surgeries and difficult experiences with health care professionals who seem not to understand or often dismiss their unique and complex needs Despite the prevalence of shared features Thalidomide survivors might also experience unique issues that are not shared with other populations with chronic pain Whilst effective pain management has become more accessible to some populations with chronic musculoskeletal pain for Thalidomide survivors inequity persists Novel research investigating the lived experience of pain by Thalidomide survivors is needed explore potential barriers in pain management of Thalidomide Survivors
To address this gap in literature the project aims to define the pain experience of beneficiaries This cross-sectional observational study entails a questionnaire booklet designed to collect numerical and categorical data about the experience of pain by Thalidomide survivors as well as the impact of pain on their lives and overall wellbeing To ensure that participants adequately represent Thalidomide survivors as a unique population a purposive sampling strategy will be followed
Distinct categories of pain have been identified in the general population such as neuropathic pain nociplastic pain or chronic primary pain The project will quantitatively via collection of new primary data explore whether these categories can be also identified in Thalidomide survivors whether one or more category is more common than others and whether there is a unique Thalidomide pain category A combination of different sets of criteria developed by the International Association for the Study of Pain IASP and patient reported outcome measures namely Central Aspects of Pain CAP and painDETECT will be used for categorising
All beneficiaries of the Thalidomide Trust can potentially be recruited n400 However past pain-related research exploring combinations of biopsychosocial variables and pain intensity 2 has shown that with estimated variation of 40 R2040 and an estimated number of independent variables 5 to 7 to be included in regression analyses 120 individuals are considered sufficient to power the study and explain 38-49 of the variance in the regression model Calculations are based on the estimated squared multiple correlation-coefficient R2 10
Regression analyses will explore whether certain factors potentially identified also as barriers in the qualitative aspect of the WP are associated with the experience of pain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None