Understanding the risk factors for neuropathic (nerve) pain in adults with diabetes and/or who have received neurotoxic chemotherapy to treat cancer
| ISRCTN | ISRCTN12494732 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12494732 |
| IRAS number | 304842 |
| Secondary identifying numbers | 2-015-22, IRAS 304842, CPMS 53774 |
- Submission date
- 07/11/2022
- Registration date
- 11/11/2022
- Last edited
- 19/12/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Neuropathic pain is caused by direct damage to the nerves. Not everyone with a disease or trauma which can cause neuropathic pain goes on to develop neuropathic pain. People who do develop neuropathic pain have a wide range of severities and outcomes. This difference in onset, severity and outcome is due to a complex interaction between genetic and environmental factors. The exact contribution and interaction of these factors is currently unknown but is vital to understand to inform treatment and prevention.
PAINSTORM is a group of research centres from the UK and Belgium. Our aim is to understand the disease processes of neuropathic pain. We also want to use this knowledge to improve the outcome for people with neuropathic pain. Our research follows on from the successful DOLORisk study, which identified factors linked with the presence, onset and outcome of neuropathic pain in the general population. We need to confirm these findings in specific populations and we will follow these people up for longer.
Dundee will lead a part of PAINSTORM (PAINSTORM Dundee Epidemiology) that aims to test the findings from DOLORisk and seek other previously unidentified associations with neuropathic pain. We will focus on two conditions that have a high risk of developing neuropathic pain – diabetes and chemotherapy treatment.
Who can participate?
Adults 18 years or older, who are on the GoDARTS register and took part in both DOLORisk Dundee questionnaires, or on the SHARE register and have diabetes mellitus and/or who have received neurotoxic chemotherapy for the treatment of cancer.
What does the study involve?
Potential participants will be invited to complete a questionnaire collecting data on any pain they may currently have, as well as important demographic, lifestyle and health related information. Participants from SHARE will complete a follow-up questionnaire, approximately 18 months after baseline.
What are the possible benefits and risks of participating?
Our study might not bring any direct benefits to participants, but we hope that the information from this large research project will improve the treatment of people receiving chemotherapy for cancer and people with diabetes and help to develop new ways to prevent or treat neuropathic pain. We do not think there will be any risks in taking part as participants will only complete a maximum of two questionnaires at home.
Where is the study run from?
University of Dundee (UK)
When is the study starting and how long is it expected to run for?
July 2021 to July 2026
Who is funding the study?
1. UK Research and Innovation
2. Versus Arthritis (UK)
3. Eli Lilly and Company (USA)
Who is the main contact?
Professor Blair H. Smith; b.h.smith@dundee.ac.uk - Principal Investigator
Dr Harry Hebert, h.hebert@dundee.ac.uk - Study Coordinator
Contact information
Principal Investigator
Division of Population Health and Genomics
Ninewells Hospital and Medical School
University of Dundee
Dundee
DD2 1UB
United Kingdom
 ORCID ID |
0000-0002-5362-9430 |
|---|---|
| Phone | +44 1382383795 |
| b.h.smith@dundee.ac.uk |
Scientific
Division of Population Health and Genomics
Ninewells Hospital and Medical School
University of Dundee
Dundee
DD2 1UB
United Kingdom
| ORCID ID |
0000-0003-1753-6592 |
|---|---|
| Phone | +44 1382383191 |
| h.hebert@dundee.ac.uk |
Public
Division of Population Health and Genomics
Ninewells Hospital and Medical School
University of Dundee
Dundee
DD2 1UB
United Kingdom
| Phone | +44 1382383191 |
|---|---|
| h.hebert@dundee.ac.uk |
Study information
| Study design | Single-centre prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Home |
| Study type | Other |
| Participant information sheet | PAINSTORM PIS full V1 23May2022.pdf |
| Scientific title | Partnership for Assessment and Investigation of Neuropathic Pain: Studies Tracking Outcomes, Risks and Mechanisms: Dundee Epidemiology study - investigating risk factors and possible causes of neuropathic pain |
| Study acronym | PAINSTORM Dundee Epidemiology |
| Study objectives | In the presence of diabetes and/or potentially neurotoxic chemotherapy, an individual's risk of developing neuropathic pain and its complications can be predicted by specific psychosocial, genetic and clinical risk factors. |
| Ethics approval(s) | Approved 26/07/2022, London - Brighton & Sussex Research Ethics Committee (Health Research Authority, 2 Redman Place, Stratford, London, E20 1JQ, UK; +44 (0)207 1048202/41; brightonandsussex.rec@hra.nhs.uk), ref: 22/PR/0803 |
| Health condition(s) or problem(s) studied | Neuropathic pain in adults with diabetes and/or who have received potentially neurotoxic chemotherapy to treat cancer. |
| Intervention | This study aims to identify and replicate genetic and environmental risk factors for developing neuropathic pain in adults with diabetes and/or who have received potentially neurotoxic chemotherapy to treat cancer, and predict its outcomes (remission or exacerbation). The identification of neuropathic pain and pain-related traits and comorbidities will mainly be achieved through longitudinal survey-based questionnaires of three cohorts, UK Biobank (general population, Great Britain), GoDARTS (diabetes, mainly Type 2, from Tayside, Scotland) and SHARE (general population, Scotland). |
| Intervention type | Other |
| Primary outcome measure | 1. Presence of neuropathic pain at baseline, 18 and 72 months, assessed using survey-based questionnaires including: 1.1. Chronic pain identification questionnaire (presence of pain, currently taking pain medication and duration) 1.2. Douleur Neuropathique en 4 questions [DN4] questionnaire 1.3. List of body sites 1.4. Michigan Neuropathy Screening Instrument [MNSI] (only those with diabetes) 1.5. European Organisation for Research and Treatment of Cancer - Chemotherapy-Induced 1.6. Peripheral Neuropathy 20-item questionnaire [EORTC-CIPN20] (only those who have received neurotoxic chemotherapy) |
| Secondary outcome measures | At baseline, 18 and 72 months, assessed using survey-based questionnaires: 1. Severity of pain: 1.1. Chronic Pain Grade (CPG) questionnaire 1.2. Brief Pain Inventory (average) 2. Quality of life: 2.1. EQ5D-5L questionnaire 3. Psychological health: 3.1. PROMIS Depression Score 3.2. PROMIS Anxiety Score 3.3. PROMIS Sleep Score 3.4. PROMIS Support 3.5. TIPI Personality questionnaire 3.6. Pain Catastrophising scale 3.7. Traumatic Experiences 4. Lifestyle: 4.1. Smoking questionnaire 4.2. Alcohol questionnaire 4.3. Saltin-Grimby Physical Activity Level Scale (SGPALS) 5. Demographics: 5.1. Age (years) 5.2. Gender 5.3. Ethnicity 5.4. Social Deprivation (SIMD) 5.5. Weight (kg) 5.6. Height (cm) 5.7. Years in full-time education 5.8. Working status 5.9. Household income 6. Clinical: 6.1. Diabetes/Chemotherapy Duration 6.2. Diabetes Type |
| Overall study start date | 01/07/2021 |
| Completion date | 14/07/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | UK Biobank - 167,000; SHARE - 7,000; GoDARTS - 500 |
| Key inclusion criteria | 1. 18 years or older 2. Existing consent to be re-contacted. 3. Identified as being currently alive. 4. Currently has a phone number, email or postal address on file 5. AND EITHER: 5.1. Adults on the SHARE register with diabetes mellitus AND/OR who have received potentially neurotoxic chemotherapy for the treatment of cancer, OR 5.2. Adults on the GoDARTS register who responded to two questionnaires for the DOLORisk Dundee study (REC reference: 15/YH/0285). |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 27/03/2023 |
| Date of final enrolment | 31/12/2025 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Dundee
DD1 4HN
United Kingdom
Sponsor information
University/education
TASC
Level 3 Residency block
Ninewells Hospital
Dundee
DD1 9SY
Scotland
United Kingdom
| Phone | +44 1382383297 |
|---|---|
| TASCgovernance@dundee.ac.uk | |
| Website | http://www.dundee.ac.uk/tasc |
"ROR" |
https://ror.org/03h2bxq36 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- UKRI
- Location
- United Kingdom
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Lilly, Eli Lilly & Company, Eli Lilly & Co., Eli Lilly And Co
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | There will be a clear PAINSTORM strategy for reporting and dissemination of scientific output, overseen by a dissemination committee. Patient partners will be active members of the dissemination committee. Patient partners will lead the identification of ways of disseminating the results and review outputs aimed at patients and public. Results will be written up in high impact open access scientific papers and presented at scientific conferences internationally. A PAINSTORM website will be created, with public access, and papers will be shared there. Where results potentially affect patient care, e.g. through the identification of stratified approaches to risk management, these will be shared with stakeholders such as patient groups, national regulatory and professional bodies, health professionals and the general public, with a view of maximising overall impact. A Final Report will be prepared for the funding body and for the Ethics Committee. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository (Alleviate Pain Data Hub/https://www.hdruk.ac.uk/helping-with-health-data/health-data-research-hubs/alleviate/). Pseudonymised, individual-level data will be stored in the Alleviate Data Hub once the study is complete. Details on requesting access will be made available at the Alleviate website (https://alleviate.ac.uk/). Specific consent will not be obtained, but participants have been informed that we may share their study information with other researchers, after personal identifiers have been removed. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Full version version 1 |
23/05/2022 | 09/11/2022 | No | Yes |
| Participant information sheet | Pocket version version 1 |
23/05/2022 | 09/11/2022 | No | Yes |
| Protocol file | version 1 | 23/05/2022 | 09/11/2022 | No | No |
| Participant information sheet | 02/06/2023 | No | Yes | ||
| Participant information sheet | 02/06/2023 | No | Yes | ||
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
19/12/2024: The recruitment end date was changed from 31/12/2024 to 31/12/2025.
05/06/2024: The recruitment end date was changed from 01/06/2024 to 31/12/2024.
07/02/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 29/02/2024 to 01/06/2024.
2. The overall end date was changed from 30/06/2025 to 14/07/2026.
3. The intention to publish date was changed from 30/06/2026 to 31/12/2026.
4. The plain English summary was updated to reflect these changes.
07/12/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2023 to 29/02/2024.
2. The intention to publish date was changed from 01/06/2025 to 30/06/2026.
02/06/2023: The following changes were made to the study record:
1. Participant information sheets uploaded.
2. Study website added.
3. The target number of participants was changed from 'UK Biobank - 167,000; SHARE - 8,000; GoDARTS - 650' to 'UK Biobank - 167,000; SHARE - 7,000; GoDARTS - 500'.
4. The recruitment start date was changed from 01/12/2022 to 27/03/2023.
5. The recruitment end date was changed from 01/06/2023 to 31/12/2023.
02/12/2022: Internal review.
09/11/2022: Trial's existence confirmed by London - Brighton & Sussex Research Ethics Committee
