The PAINSTORM project aims to understand, better assess, and ultimately treat neuropathic pain. To do this, we are recruiting people living with neuropathic pain or at risk of developing neuropathic pain. The way we recruit participants - the questionnaires we use and the data we collect - needs to be the same across all centres: this research theme makes sure that the protocols are harmonised.
We are recruiting participants using questionnaires which we send to participants, or in some cases which are available in large national datasets, such as UK Biobank. Additionally, in three PAINSTORM centres (the University of Dundee, the University of Oxford, and Imperial College London), participants have more detailed assessment, which is called "deep phenotyping". Where possible, we will follow participants over time to see if their symptoms change. We are including a number of conditions that increase the risk of neuropathic pain, including nerve damage (peripheral neuropathy) due to diabetes, HIV infection and chemotherapy treatment.
We aim to be consistent in the way that we assess neuropathic pain, using some measures and questionnaires which are common to all participants as well as some that are designed to be used in specific conditions. We are working with our patient partners and charities to try and ensure participants of diverse backgrounds and ethnicities are represented in PAINSTORM, and that our approaches to assessing neuropathic pain are meaningful for those living with it. We harmonised our phenotyping methods and are now recruiting across a range of neuropathic pain disorders, such as:
- Diabetic neuropathy
- Chemotherapy-induced neuropathy
- HIV-induced neuropathy
- Rare or extreme pain disorders, for instance genetically inherited conditions
- Peripheral neuropathy from unknown origin
We will also collaborate with other projects to widen our reach, for instance with the FORECAST study investigating longitudinal outcomes in sciatica.
To decide whether a participant has neuropathic pain or not, we use the Neuropathic Pain Special Interest Group grading algorithm of neuropathic pain. Our questionnaires also include validated screening tools for neuropathic pain.
- At the start of PAINSTORM, we aligned recruitment protocols between the sites. These protocols were based on the ones used in the DOLORisk study, to which we made some modifications. Patient Partners gave us feedback on the questionnaires and made suggestions to better capture the experience of living with chronic pain. Now, all participants answer a common set of questionnaires (the "core protocol"), and study participants who also come in for a clinic visit answer additional questions (the "extended protocol"), which gives us a more detailed view of their disease and how they experience pain.
- The first phase of recruitment has ended. We are now following up participants to know how their condition has evolved since their first visit.
In the meantime:
- We used the UK Biobank data to analyse what proportion of participants have neuropathic pain. We also looked for factors that are more present for people with neuropathic pain. We found that people with neuropathic pain are more likely to be younger, be female, and have worse health-related quality of life, than people who have no chronic pain. Among people who have a neuropathy, those experiencing pain were more likely to be men and to have a higher body mass index. The full results are presented in this paper: Epidemiology of neuropathic pain: an analysis of prevalence and associated factors in UK Biobank
- The FORECAST study contributed to a review of how neuropathic pain is diagnosed in people with sciatica. The review panel proposed adapting the neuropathic pain grading system in the context of spine-related leg pain, This will make it easier to identify neuropathic pain and propose specific management for people who have sciatica. The full recommendations were published in the journal PAIN: Recommendations for terminology and the identification of neuropathic pain in people with spine-related leg pain. Outcomes from the NeuPSIG working group
- Several PAINSTORM members were involved in an effort to write recommendations on using screening questionnaires and diagnostic tests for neuropathic pain. This was a joint effort between the European Academy of Neurology (EAN), the European Pain Federation (EPN), and the Neuropathic Pain Special Interest Group (NeuPSIG) of the International Association for the Study of Pain (IASP). They issued strong and weak recommendations based on how much evidence supports specific questionnaires and tests. They also concluded that the evidence is often of poor or moderate quality and that More large, well-designed, multicentre studies that assess the accuracy of diagnostic tests for neuropathic pain are needed. Read the guidelines here: Joint European Academy of Neurology-European Pain Federation-Neuropathic Pain Special Interest Group of the International Association for the Study of Pain guidelines on neuropathic pain assessment
- The protocol of the DOLORisk study inspired the PAINSTORM protocol and uses the same principle of "core" and "extended" protocols: DOLORisk: study protocol for a multi-centre observational study to understand the risk factors and determinants of neuropathic pain [version 2; peer review: 2 approved]
- This paper introduces the grading algorithm for neuropathic pain developed by the Neuropathic Pain Special Interest Group (NeuPSIG) of the International Association for the Study of Pain: Neuropathic pain: an updated grading system for research and clinical practice
- The FORECAST study of sciatica published their protocol, which is aligned with the PAINSTORM extended protocol: Factors predicting the transition from acute to persistent pain in people with 'sciatica': the FORECAST longitudinal prognostic factor cohort study protocol
- The Journal of Pain published a series of essential articles on confronting racism in pain research:
- This review highlights the importance of understanding variations in the rate of diabetic peripheral neuropathy in different countries and region. Understanding local variations can inform public health policy and help allocate resources where needed. Read the key points here: The global and regional burden of diabetic peripheral neuropathy
