The 4th European Congress on

Clinical Trials in Pain

Ruth Zaslansky,1 Phlipp Baumbach,1 Winfried Meissner,1 and the PAIN OUT collaborative

Dept. of Anaesthesiology and Intensive Care, University Hospital Jena, Erlanger Allee 101, D 07740 Jena, Germany.

A person’s response to pain is a complex interaction between biological, psychological and social factors.  When carried out in a single country, the focus of pain studies is often on the biological and/or psychological factors. When multi-country studies are carried out, social or ‘cultural’ factors will potentially affect responses. ‘Culture’ is difficult to define and to operationalize. The effects of ‘culture’ on pain should probably not be ignored as there may be need to adapt assessment tools and/or treatments when they are applied in countries or to people who speak languages other  than where they were first developed. Clinicians, researchers and regulatory authorities, should be aware about these ‘cultural’ components so they are taken into account when these stakeholders carry out their respective tasks.1,2

In the international, perioperative pain registry, PAIN OUT, we compared  patient reported outcomes (PROs) from a sample of American patients after orthopedic surgery with patients’ reports  from 13 countries (‘International’).3  USA patients rated some PROs higher than  the ‘International’ patients, specifically ‘worst pain’; for other PROs, differences were not so apparent. This was puzzling. Were the differences in ‘worst pain’ assessments related to culture? To differences in care?  Is this a methods question? Is ‘worst pain’  less sensitive to change compared to some other PROs? It is one of the most commonly used PROs in pain studies.

These preliminary findings apply to reports of acute pain in patients after orthopedic surgery.  We are in the process of carrying out studies in additional patient populations and pain conditions, acute and chronic.  Results will be presented and discussed during the talk.

1. Sharma, S, Ferreira-Valente, A, de C. Williams, A.C., Abbott,JH , Pais-Ribeiro, J , Jensen, M.P , Group Differences Between Countries and Between Languages in Pain-Related Beliefs, Coping, and Catastrophizing in Chronic Pain: A Systematic Review, Pain Medicine, pnz373, https://doi.org/10.1093/pm/pnz373
2. Feng, Y., Herdman, M., van Nooten, F. et al. An exploration of differences between Japan and two European countries in the self-reporting and valuation of pain and discomfort on the EQ-5D. Qual Life Res 26, 2067–2078 (2017). https://doi.org/10.1007/s11136-017-1541-5
3. Zaslansky R, Meissner W, Chapman CR. Pain after orthopaedic surgery: differences in patient reported outcomes in the United States vs internationally. An observational study from the PAIN OUT dataset. Br J Anaesth. 2018;120(4):790-797. doi:10.1016/j.bja.2017.11.109

As the SARS-Cov-2 pandemic requires special attention on its psychological effects and the impact on patients with chronic pain, we conducted a study aimed at examining the influence of the COVID-19 pandemic- associated restrictions initiated by the German government on pain intensity and characteristics, emotional well-being and everyday life of patients with painful polyneuropathy.

43 patients (well-assessed with questionnaires prior to the pandemic and without change of their health status between baseline and current assessment) were investigated with validated, standardised self-reported questionnaires two weeks after the restrictions came into effect.

Pain intensity remained stable or even improved while the Rumination scores of the Pain Catastrophizing Scale were lower during compared to before the pandemic restrictions.

Results suggest a shift of attention from the chronic pain condition towards the imminent threat of a global pandemic. As the impacts of the pandemic are persistent and evolving, the development of the measured parameters during the course of it will be of great interest.