PERCIPIENT - An Evaluation of Pain Biomarkers and Body Representation Outcomes After Distal Radius Fracture

What is the problem? A wrist fracture is a common injury, affecting about 100,000 people in the UK each year. While most people recover well, a significant minority, between 10% and 20%, develop persistent pain and disability that lasts long after the bone has healed. In some cases this leads to a severe chronic pain condition called Complex Regional Pain Syndrome (CRPS). Currently we cannot easily predict who will recover and who may not, making it challenging to provide early targeted support.

What are we trying to find out? We want to see if we can identify "signs" in the body, such as genetic markers, chemical messengers in the blood, and heart rate rhythms, that predict a person's recovery. We are also investigating the brain's "internal map" of the body. After an injury, this map can sometimes become "blurred" or less precise, which we believe is linked to ongoing pain. Our goal is to use this information to help in identify patients at high risk of chronic pain so they could receive better treatment in the future.

What will happen in the study? We are inviting 250 participants: 200 people with a recent wrist fracture and 50 people who already live with long-term CRPS to act as a comparison group.

All participants will first take part in a baseline assessment. This involves completing questionnaires (including a 0-10 pain rating scale), providing a blood sample, and taking part in simple bedside tests. These tests will also measure your internal body map by checking how accurately you can identify finger touches with your eyes closed and how you compare the size or weight of your limbs.

Based on the results of these objective tests, we will invite some participants with recent wrist fractures to take part in specific sub-studies:

• Brain Scans (24 people): If the bedside tests show changes in your internal map, we will invite you for two fMRI scans, six months apart, to watch the internal map in action whilst performing simple hand tasks.
• Fitness Watches (50 people): Based on your pain rating scores, we will invite 25 people with higher pain and 25 people with lower pain to wear a watch for five days, at the beginning and end of their recovery, to track heart rate rhythms.
• Virtual Reality (20 people): If you still have ongoing pain or a blurred internal map at 6 months, we may invite you to test at-home VR equipment to see if it helps re-train the brain.

Who are we? Our research team includes experts in genetics, brain imaging, pain, and modern digital technologies who have experience in delivering clinical trials.

How will we tell people what we found out?

We are committed to sharing what we learn with the people who make our research possible. We will therefore inform participants and public. Once the study is complete, we will:

• Publish a plain English summary of the results to the public registry ClinicalTrials.gov within 12 months of the study ending
• Provide a direct update to participants who have consented to be contacted for future research via email
• Offer community sharing of our findings through our sponsor Cambridge Arthritis Research Endeavour (CARE) website
• Publish in Academic literature the full scientific results in medical journals to ensure that other doctors and researchers can learn from this study