Protocols and recruitment (WP1)

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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.
  • All recruitment centres in Oxford, Dundee, and London have received ethics approvals and are actively recruiting participants.

  1. This paper presents the protocol of the DOLORisk study, which 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] Open Access logo which is a illustration of an open padlock
  2. 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 Open Access logo which is a illustration of an open padlock
  3. The Journal of Pain published a series of essential articles on confronting racism in pain research:
    1. A Call to Action Open Access logo which is a illustration of an open padlock
    2. Reframing Study Designs Open Access logo which is a illustration of an open padlock
    3. A Shared Commitment for Engagement, Diversity, and Dissemination Open Access logo which is a illustration of an open padlock