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Patient-Reported Outcomes

Pain is complex and difficult to measure

 

To evaluate the benefits of new pain treatments, we need to be able to accurately measure pain. There is no simple scan or blood test that we can use to do this; we are reliant on patient-reported outcome measures (PROs).

Current PRO reality

PROs normally come in the form of a questionnaire, scale or diary that patients use to report on the status of their health condition. However, many of the current PROs used for pain are too simple – the most commonly accepted scales by regulatory authorities are the visual analogue scale or numeric rating scale, where patients are asked to rate their ‘usual level of pain on a scale of 0–10’. They do not measure other aspects such as pain quality or impact on quality of life and are limited by factors such as recall bias.

0-10 Numeric Pain Rating Scale



Vulvodynia is a highly prevalent condition of the vulva leading to painful sex and chronic pelvic pain. Current PROs specific to vaginal and vulval health focus primarily on sexual quality of life with little focus on pain, lacking granular questioning on patient pain. There is an unmet need for a new instrument that includes quality of life measures and the impact of pain on patient outcomes, such as the ability to use tampons or wear tight trousers.

"Pain limits, isolates, and slows down lives; a 0–10 scale does not apply"

Future PRO reality

We want to change the current PRO reality. As innovators, we are committed to improving the health environment beyond developing new drugs and devices. In partnership with patients and experts, we are developing novel disease-specific PROs and new ways to assess functional outcomes.

Chronic low back pain is an extremely common disorder that is associated with long-term pain and disability. Grünenthal recognised that PRO instruments measuring its impact on patients would often present pain as a single overall concept, which may not fully capture the pain sensations of this condition. We therefore used this unmet need as an opportunity to develop the Patient Assessment for Low Back Pain–Symptoms (PAL-S), a PRO assessment tool designed to specifically reflect the pain sensations experienced by patients with chronic low back pain. Read more about the mixed-methods development of this tool here.

Latest Updates

Targeting TRPV

Transient receptor potential (TRP) ion channels are involved in nociception and play roles in several types of pain, including inflammatory pain, neuropathic pain and visceral pain. Pharmacological modulation of TRP channels may provide an alternative to opioid- or NSAID-based pain treatments. Here we review developments in this promising approach to pain management.

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Placebo Effect and Pain - Part 2

In the second instalment of this 2-part article, we consider how researchers designing clinical trials for pain management can adapt their trial methodologies to take account of the placebo response. Various options to reduce the likelihood of ‘false negative’ trial outcomes when investigating novel options for chronic pain are proposed.

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Re-defining pain through patient-inspired R&D

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