Pain, ChronicTRIUMPH-TSNCT06398132
Understanding and Managing Pain for Thalidomide Survivors
An observational study of Pain, Chronic and Pain, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain, Chronic, Pain
- How many people
- 73 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 May 2024to 2 Feb 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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, under-represented, and disadvantaged group of people who must overcome a number of additional barriers in order to receive appropriate care.
Who may be able to join
- Be beneficiaries of the Thalidomide Trust
- Be able to communicate in English or via using the British Sign Language as all interview questions and questionnaires are designed in the English language
Who cannot join
- Inability to give informed consent due to cognitive impairment or otherwise - (capacity levels are already established under General Practitioner (GP) care)
- Inability to understand key aspects of the study due to cognitive impairment or otherwise
- Giving history of critical or terminal co-morbidities such as cancer
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Sciences Building - City Hospital Campus
Nottingham, Nottinghamshire, NG5 1PB
About this study
Official title: Thalidomide-Related Investigation on Understanding and Managing Pain for Thalidomide Survivors
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.
Read more
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.
Read the 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 and/or 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 Children's 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 (e.g., 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 (n≈400). However, past pain-related research exploring combinations of biopsychosocial variables and pain intensity 2 has shown that with estimated variation of 40% (R2=0.40) 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.
- Conditions
- Pain, Chronic, Pain
- Being tested
- Usual Care
- Keywords
- Thalidomide, Pain, Pain Management, Intervention Development
- Medical subject headings
- Chronic Pain, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
Usual Care includes among others, over-the-counter or prescribed painkillers, treatment modalities such as physiotherapy and/or psychotherapy, privately accessed or via the National Health Service, exercise, etc.
| Study group | Role | What they receive |
|---|---|---|
| Thalidomide Survivors | The group will include Thalidomide Survivors (n=120), who are beneficiaries of the Thalidomide Trust and receive Usual Care for the management of their pain. Usual Care includes among others, over-the-counter or prescribed painkillers, treatment modalities such as physiotherapy and/or psychotherapy, privately accessed or via the National Health Service, exercise, etc. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Aspects of Pain (CAP) [Modified]
A tool featuring 7 questions and a body manikin, designed to indicate distinct central pain mechanisms. Higher scores indicate dominance of central mechanisms in the overall pain experience. A modified version without the manikin [the tick-box choices for each body site used in CAP will be applied] will be used out of respect to Thalidomide Survivors. A modified version replacing the manikin with tick-box available for each body site will be used out of respect to Thalidomide Survivors.
Measured: Through study completion, an average of 1 year
painDETECT (PDQ) [Modified]
A tool featuring 9 questions and a body manikin, designed to indicate neuropathic mechanisms for pain. Higher scores indicate dominance of neuropathic mechanisms in the overall pain experience. A modified version without the manikin [the tick-box choices for each body site used in CAP will be applied] will be used out of respect to Thalidomide Survivors.
Measured: Through study completion, an average of 1 year
Widespread Pain Index (WPI) [Modified]
A tool featuring a body manikin, 3 symptom severity scales, measuring fatigue, waking up unrefreshed, and cognitive dysfunction, and a somatic symptoms list. Higher scores indicate dominance of central mechanisms and increased likelihood of a positive diagnosis of fibromyalgia. A modified version without the manikin [the tick-box choices for each body site used in CAP will be applied] will be used out of respect to Thalidomide Survivors.
Measured: Through study completion, an average of 1 year
Secondary outcomes (8)
0-10 Numerical Rating Scale (NRS)
Three simple 0-10 numerical rating scales (min: 0 = no pain, max: 10 = extreme pain) asking to rate pain severity now, strongest pain over the last week, and average pain over the last week.Higher scores mean higher pain severity.
Measured: Through study completion, an average of 1 year
Hospital Anxiety and Depression Scale (HADS)
HADS is comprised by 7 questions about depression (min: 0, max: 21) and 7 questions about anxiety (min: 0, max: 21). Each component yields a distinct score. Higher scores indicate higher levels of symptoms of depression and anxiety.
Measured: Through study completion, an average of 1 year
Pain Catastrophizing Scale (PCS)
PCS is comprised by 13 questions aiming to capture thoughts people have about their pain (min: 0, max: 52). Higher score indicates higher levels of catastrophizing.
Measured: Through study completion, an average of 1 year
Tampa Scale of Kinesiophobia (TSK)
TSK is comprised by 17 questions aiming to thoughts and fears they have developed about their pain, as well as movements associated with it (min: 17, max: 68). Higher score indicates higher levels of kinesiophobia
Measured: Through study completion, an average of 1 year
EuroQoL 5-Dimensions 5-Levels (EQ-5D-5L)
EQ-5D-5L is comprised by 5 dimensions (Mobility, Self-care, Usual Activities, Pain/Discomfort, Anxiety/Depression), each comprised by 5 distinct levels of severity. An index score (min: 0.0, max: 1.0) is produced that indicates quality of life for each individual. Additionally, a 0-100 Visual Analogue Scale (min: 0, max: 100) provides insight about overall health. Higher scores indicate better overall health.
Measured: Through study completion, an average of 1 year
Health Assessment Questionnaire - Disability (HAQ-DI)
HAQ-DI is comprised by distinct dimensions (Dressing \& Grooming, Arising, Eating, Walking, Aids or Devices, Hygiene, Reach, Grip, Activities, and Help from Another Person) (min:0, max: 3 on each category). The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). Higher score indicates higher levels of disability.
Measured: Through study completion, an average of 1 year
Athens Insomnia Scale (AIS)
AIS is comprised by 8 questions (min: 0, max: 28) about sleeping habits and sleep quality. Higher score indicates higher levels of sleep disturbance and insomnia.
Measured: Through study completion, an average of 1 year
Pain Medication Attitude Questionnaire (PMAQ)
PMAQ is comprised by 7 domains [Addiction (min: 0, max: 25), Need (min: 0, max: 40), Scrutiny (min: 0, max: 40), Side effects (min: 0, max: 35), Tolerance (min: 0, max: 30), Mistrust of Doctors (min: 0, max: 35), Withdrawal (min: 0, max: 30) reflected in 47 questions about medicines use and attitudes towards them. Higher score within each domain indicates higher levels of sub-optimal medicines use and negative attitudes towards them.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start15 May 2024
- Primary completion2 Feb 2025
- Study completion2 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- Cross-sectional
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- The Thalidomide Trust
- Responsible party
- Principal investigator, Vasileios Georgopoulos, University of Nottingham
- Investigators
- Vasileios Georgopoulos, PhD, Principal investigator, University of NottinghamDavid A. Walsh, PhD, Study chair, University of NottinghamDaniel F. McWilliams, PhD, Study chair, University of NottinghamFionna Moffatt, PhD, Study chair, University of NottinghamHolly Blake, PhD, Study chair, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398132
- Sponsor's protocol ID
- 112-0224
- Acronym
- TRIUMPH-TS
- Status last verified
- Mar 2025
- First submitted
- 24 Apr 2024
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Agreement is already in place for anonymised raw data of all study outcomes to be shared with the Thalidomide Trust. Agreement is already in place for anonymised raw dat of the painDETECT questionnaire to be shared with IQVIA, who is the provider of the tool.
Publications
Smithells RW, Newman CG. Recognition of thalidomide defects. J Med Genet. 1992 Oct;29(10):716-23. doi: 10.1136/jmg.29.10.716. No abstract available.
PubMed 1433232Niecke A, Peters KM, Alayli A, Lungen M, Pfaff H, Albus C, Samel C. Health-related quality of life after 50 years in individuals with thalidomide embryopathy: Evidence from a German cross-sectional survey. Birth Defects Res. 2022 Aug 1;114(13):714-724. doi: 10.1002/bdr2.2051. Epub 2022 Jun 4.
PubMed 35666030Ghassemi Jahani SA, Karlsson J, Brisby H, Danielsson AJ. Health-related quality of life and function in middle-aged individuals with thalidomide embryopathy. J Child Orthop. 2016 Dec;10(6):691-703. doi: 10.1007/s11832-016-0797-6. Epub 2016 Nov 16.
PubMed 27854003Jankelowitz SK, Spies JM, Burke D. Late-onset neurological symptoms in thalidomide-exposed subjects: a study of an Australasian cohort. Eur J Neurol. 2013 Mar;20(3):509-514. doi: 10.1111/ene.12005. Epub 2012 Oct 18.
PubMed 23078293Vargesson N, Hooper G, Giddins G, Hunter A, Stirling P, Lam W. Thalidomide upper limb embryopathy - pathogenesis, past and present management and future considerations. J Hand Surg Eur Vol. 2023 Sep;48(8):699-709. doi: 10.1177/17531934231177425. Epub 2023 May 24.
PubMed 37226469Newbronner E, Glendinning C, Atkin K, Wadman R. The health and quality of life of Thalidomide survivors as they age - Evidence from a UK survey. PLoS One. 2019 Jan 16;14(1):e0210222. doi: 10.1371/journal.pone.0210222. eCollection 2019.
PubMed 30650111Nijs J, George SZ, Clauw DJ, Fernandez-de-Las-Penas C, Kosek E, Ickmans K, Fernandez-Carnero J, Polli A, Kapreli E, Huysmans E, Cuesta-Vargas AI, Mani R, Lundberg M, Leysen L, Rice D, Sterling M, Curatolo M. Central sensitisation in chronic pain conditions: latest discoveries and their potential for precision medicine. Lancet Rheumatol. 2021 May;3(5):e383-e392. doi: 10.1016/S2665-9913(21)00032-1. Epub 2021 Mar 30.
PubMed 38279393Nijs J, Lahousse A, Kapreli E, Bilika P, Saracoglu I, Malfliet A, Coppieters I, De Baets L, Leysen L, Roose E, Clark J, Voogt L, Huysmans E. Nociplastic Pain Criteria or Recognition of Central Sensitization? Pain Phenotyping in the Past, Present and Future. J Clin Med. 2021 Jul 21;10(15):3203. doi: 10.3390/jcm10153203.
PubMed 34361986Chronic pain (primary and secondary) in over 16s: assessment of all chronic pain and management of chronic primary pain. London: National Institute for Health and Care Excellence (NICE); 2021 Apr 7. Available from http://www.ncbi.nlm.nih.gov/books/NBK569960/
PubMed 33939353Knofczynski GT, Mundfrom D. Sample sizes when using multiple linear regression for prediction. Educational and Psychological Measurement. 2008;68(3):431-442.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thalidomide-Related Investigation on Understanding and Managing Pain for Thalidomide Survivors
- ClinicalTrials.gov ID
- NCT06398132
- Acronym / sponsor ID
- TRIUMPH-TS / 112-0224
- Conditions
- Pain, Chronic, Pain
- Keywords
- Thalidomide, Pain, Pain Management, Intervention Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- The Thalidomide Trust
- Study start
- 15 May 2024 (actual)
- Primary completion
- 2 Feb 2025 (actual)
- Study completion
- 2 Feb 2025 (actual)
- First posted
- 3 May 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.
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.
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 and/or 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 Children's 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 (e.g., 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 (n≈400). However, past pain-related research exploring combinations of biopsychosocial variables and pain intensity 2 has shown that with estimated variation of 40% (R2=0.40) 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thalidomide Survivors | – | Other: Usual CareThe group will include Thalidomide Survivors (n=120), who are beneficiaries of the Thalidomide Trust and receive Usual Care for the management of their pain. Usual Care includes among others, over-the-counter or prescribed painkillers, treatment modalities such as physiotherapy and/or psychotherapy, privately accessed or via the National Health Service, exercise, etc. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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, under-represented, and disadvantaged group of people who must overcome a number of additional barriers in order to receive appropriate care.
Key inclusion criteria (2 listed)
- Be beneficiaries of the Thalidomide Trust
- Be able to communicate in English or via using the British Sign Language as all interview questions and questionnaires are designed in the English language
Key exclusion criteria (3 listed)
- Inability to give informed consent due to cognitive impairment or otherwise - (capacity levels are already established under General Practitioner (GP) care)
- Inability to understand key aspects of the study due to cognitive impairment or otherwise
- Giving history of critical or terminal co-morbidities such as cancer
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 |
|---|---|---|
| Usual CareUsual Care includes among others, over-the-counter or prescribed painkillers, treatment modalities such as physiotherapy and/or psychotherapy, privately accessed or via the National Health Service, exercise, etc. | Other | Thalidomide Survivors |
Primary outcome
Central Aspects of Pain (CAP) [Modified]
Time frame: Through study completion, an average of 1 year
A tool featuring 7 questions and a body manikin, designed to indicate distinct central pain mechanisms. Higher scores indicate dominance of central mechanisms in the overall pain experience. A modified version without the manikin [the tick-box choices for each body site used in CAP will be applied] will be used out of respect to Thalidomide Survivors. A modified version replacing the manikin with tick-box available for each body site will be used out of respect to Thalidomide Survivors.
painDETECT (PDQ) [Modified]
Time frame: Through study completion, an average of 1 year
A tool featuring 9 questions and a body manikin, designed to indicate neuropathic mechanisms for pain. Higher scores indicate dominance of neuropathic mechanisms in the overall pain experience. A modified version without the manikin [the tick-box choices for each body site used in CAP will be applied] will be used out of respect to Thalidomide Survivors.
Widespread Pain Index (WPI) [Modified]
Time frame: Through study completion, an average of 1 year
A tool featuring a body manikin, 3 symptom severity scales, measuring fatigue, waking up unrefreshed, and cognitive dysfunction, and a somatic symptoms list. Higher scores indicate dominance of central mechanisms and increased likelihood of a positive diagnosis of fibromyalgia. A modified version without the manikin [the tick-box choices for each body site used in CAP will be applied] will be used out of respect to Thalidomide Survivors.
8 secondary outcomes
0-10 Numerical Rating Scale (NRS)
Time frame: Through study completion, an average of 1 year
Hospital Anxiety and Depression Scale (HADS)
Time frame: Through study completion, an average of 1 year
Pain Catastrophizing Scale (PCS)
Time frame: Through study completion, an average of 1 year
Tampa Scale of Kinesiophobia (TSK)
Time frame: Through study completion, an average of 1 year
EuroQoL 5-Dimensions 5-Levels (EQ-5D-5L)
Time frame: Through study completion, an average of 1 year
Health Assessment Questionnaire - Disability (HAQ-DI)
Time frame: Through study completion, an average of 1 year
Athens Insomnia Scale (AIS)
Time frame: Through study completion, an average of 1 year
Pain Medication Attitude Questionnaire (PMAQ)
Time frame: Through study completion, an average of 1 year
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 24 Mar 2025.
- Background: PubMed 1433232Smithells RW, Newman CG. Recognition of thalidomide defects. J Med Genet. 1992 Oct;29(10):716-23. doi: 10.1136/jmg.29.10.716. No abstract available.
- Background: PubMed 35666030Niecke A, Peters KM, Alayli A, Lungen M, Pfaff H, Albus C, Samel C. Health-related quality of life after 50 years in individuals with thalidomide embryopathy: Evidence from a German cross-sectional survey. Birth Defects Res. 2022 Aug 1;114(13):714-724. doi: 10.1002/bdr2.2051. Epub 2022 Jun 4.
- Background: PubMed 27854003Ghassemi Jahani SA, Karlsson J, Brisby H, Danielsson AJ. Health-related quality of life and function in middle-aged individuals with thalidomide embryopathy. J Child Orthop. 2016 Dec;10(6):691-703. doi: 10.1007/s11832-016-0797-6. Epub 2016 Nov 16.
- Background: PubMed 23078293Jankelowitz SK, Spies JM, Burke D. Late-onset neurological symptoms in thalidomide-exposed subjects: a study of an Australasian cohort. Eur J Neurol. 2013 Mar;20(3):509-514. doi: 10.1111/ene.12005. Epub 2012 Oct 18.
- Background: PubMed 37226469Vargesson N, Hooper G, Giddins G, Hunter A, Stirling P, Lam W. Thalidomide upper limb embryopathy - pathogenesis, past and present management and future considerations. J Hand Surg Eur Vol. 2023 Sep;48(8):699-709. doi: 10.1177/17531934231177425. Epub 2023 May 24.
- Background: PubMed 30650111Newbronner E, Glendinning C, Atkin K, Wadman R. The health and quality of life of Thalidomide survivors as they age - Evidence from a UK survey. PLoS One. 2019 Jan 16;14(1):e0210222. doi: 10.1371/journal.pone.0210222. eCollection 2019.
- Background: PubMed 38279393Nijs J, George SZ, Clauw DJ, Fernandez-de-Las-Penas C, Kosek E, Ickmans K, Fernandez-Carnero J, Polli A, Kapreli E, Huysmans E, Cuesta-Vargas AI, Mani R, Lundberg M, Leysen L, Rice D, Sterling M, Curatolo M. Central sensitisation in chronic pain conditions: latest discoveries and their potential for precision medicine. Lancet Rheumatol. 2021 May;3(5):e383-e392. doi: 10.1016/S2665-9913(21)00032-1. Epub 2021 Mar 30.
- Background: PubMed 34361986Nijs J, Lahousse A, Kapreli E, Bilika P, Saracoglu I, Malfliet A, Coppieters I, De Baets L, Leysen L, Roose E, Clark J, Voogt L, Huysmans E. Nociplastic Pain Criteria or Recognition of Central Sensitization? Pain Phenotyping in the Past, Present and Future. J Clin Med. 2021 Jul 21;10(15):3203. doi: 10.3390/jcm10153203.
- Background: PubMed 33939353Chronic pain (primary and secondary) in over 16s: assessment of all chronic pain and management of chronic primary pain. London: National Institute for Health and Care Excellence (NICE); 2021 Apr 7. Available from http://www.ncbi.nlm.nih.gov/books/NBK569960/
- BackgroundKnofczynski GT, Mundfrom D. Sample sizes when using multiple linear regression for prediction. Educational and Psychological Measurement. 2008;68(3):431-442.
- Individual participant dataSharing planned: Yes. Agreement is already in place for anonymised raw data of all study outcomes to be shared with the Thalidomide Trust. Agreement is already in place for anonymised raw dat of the painDETECT questionnaire to be shared with IQVIA, who is the provider of the tool.
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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.
Vasileios Georgopoulos, PhD principal investigator
University of Nottingham
David A. Walsh, PhD study chair
University of Nottingham
Daniel F. McWilliams, PhD study chair
University of Nottingham
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 Pain, Chronic and Pain, run by University of Nottingham at 1 site in United Kingdom.
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 2 inclusion and 3 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 24 Mar 2025. 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 United Kingdom. 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?
Central Aspects of Pain (CAP) [Modified] (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06398132, which also lists 10 linked publications.
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 24 Mar 2025.