Understanding and Managing Pain for Thalidomide Survivors

NCT06398132 | Completed

• 1 other identifier: 112-0224
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Chronic; Pain

Keywords

Thalidomide; Pain; Pain Management; Intervention Development

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Through study completion, an average of 1 year

Secondary Outcomes (8)

• 0-10 Numerical Rating Scale (NRS)

  Through study completion, an average of 1 year

• Hospital Anxiety and Depression Scale (HADS)

  Through study completion, an average of 1 year

• Pain Catastrophizing Scale (PCS)

  Through study completion, an average of 1 year

• Tampa Scale of Kinesiophobia (TSK)

  Through study completion, an average of 1 year

• EuroQoL 5-Dimensions 5-Levels (EQ-5D-5L)

  Through study completion, an average of 1 year

Study Arms (1)

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.

Other: Usual Care

Interventions

Usual Care OTHER

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.

Thalidomide Survivors

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead
• The Thalidomide Trust: collaborator

Study Sites (1)

Clinical Sciences Building - City Hospital Campus

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Related Publications (10)

• 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.

  PMID: 1433232 BACKGROUND

• Niecke 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.

  PMID: 35666030 BACKGROUND

• Ghassemi 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.

  PMID: 27854003 BACKGROUND

• Jankelowitz 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.

  PMID: 23078293 BACKGROUND

• Vargesson 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.

  PMID: 37226469 BACKGROUND

• Newbronner 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.

  PMID: 30650111 BACKGROUND

• Nijs 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.

  PMID: 38279393 BACKGROUND

• Nijs 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.

  PMID: 34361986 BACKGROUND

• Chronic 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/

  PMID: 33939353 BACKGROUND

• Knofczynski GT, Mundfrom D. Sample sizes when using multiple linear regression for prediction. Educational and Psychological Measurement. 2008;68(3):431-442.

  BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Vasileios Georgopoulos, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

• David A. Walsh, PhD

  University of Nottingham

  STUDY CHAIR

• Daniel F. McWilliams, PhD

  University of Nottingham

  STUDY CHAIR

• Fionna Moffatt, PhD

  University of Nottingham

  STUDY CHAIR

• Holly Blake, PhD

  University of Nottingham

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 3, 2024
• Study Start: May 15, 2024
• Primary Completion: February 2, 2025
• Study Completion: February 2, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: For the Thalidomide Trust, after analysis is completed. For IQVIA, as soon as recruitment ends and data input is complete.
• Access Criteria: A separate data sharing agreement will need to be signed, as per the policies of the University of Nottingham, with each party wishing to access the data of this study.

Locations

GB (1)