How the Brain and Body Recover After a Wrist Fracture

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

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07777081
Lead Sponsor: Cambridge University Hospitals NHS Foundation TrustOTHER
Overall Status: Recruiting
Study Type: Observational
Enrollment: 200Estimated
Last Update Posted: Aug 20, 2026Actual
Start Date: Aug 12, 2026Actual
Primary Completion Date: Aug 12, 2031Estimated
Completion Date: Aug 12, 2032Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: PERCIPIENT - An Evaluation of Pain Biomarkers and Body Representation Outcomes After Distal Radius Fracture
Brief Summary: 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

Conditions

The medical conditions and diseases this study investigates.

Wrist Fracture
Complex Regional Pain Syndrome

Interventions

The treatments and procedures being evaluated in this study.

No interventions

There are no interventions for this study.

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Distal radius fracture (DRF) within past 6 weeks 18 and older Willing and competent to complete the informed consent process

Exclusion Criteria:

Inability to understand the informed consent process (Language, competence) Multiple trauma Significant neurological disease (multiple sclerosis, previous traumatic brain injury, previous stroke or cerebral haemorrhage and substantial tremor - including Parkinson's, significant resting tremor, or other aetiology) Amputation or medical confirmation of unilateral sensory deficit

Design

How the study is designed and how its participant groups are organized.

Observational Model: Cohort
Time Perspective: Prospective

Contacts

The people to reach with questions about this study or how to join it.

Neal Chauhan, MBBSContact

neal.chauhan@nhs.net01223 216182

Locations

Where the study is run and whether each site is currently recruiting.

Addenbrooke's HospitalRecruiting

Cambridge, Cambridgeshire CB2 0QQ, United Kingdom

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Cambridge University Hospitals NHS Foundation TrustOTHER
Collaborators

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Detailed Description

Study Design Prospective cohort Study Participants (1) Patients aged 18 years and older, with an acute fracture of the distal radius within the past 6 weeks, willing and competent to complete the informed consent process. Patients with multiple trauma; have had an open fracture; have a unilateral sensory deficit; significant neurological disease or patients who would be unable to follow trial procedures will be excluded.

(2) Participants with Chronic Complex Regional Pain Syndrome (CRPS), willing and competent to complete the informed consent process.

Planned Size of Sample Total of 250 participants

200 with distal radius fractures
50 with chronic CRPS Planned Study Period September 2025 - 2029 (4 years) Research Aim The primary aim of this study is to perform multi-domain deep phenotyping of patients following a distal radius fracture, to generate novel hypotheses regarding the biological and physiological mechanisms that predict the transition to chronic pain and Complex Regional Pain Syndrome (CRPS).

Key research questions

Validate candidate genes and identify molecular biomarkers associated with pain persistence and development of CRPS
To characterise the neurobiological and bodily representation changes that occur following a wrist fracture and their impact on the patient experience using fMRI
Investigate autonomic nervous system function as a potential predictor of clinical outcomes using Wearable digital technology
To assess the feasibility and acceptability of home-based Virtual Reality interventions in body representation disorder and pain persistence patients

Domain level objectives Objectives Outcome measures Time point(s) of evaluation

Genetic and Molecular biomarkers 1a) Validate candidate genes, previously identified in chronic CRPS cohorts, in a prospective cohort of at-risk patients' post-fracture Frequency of four specific CRPS associated SNPs determined through PCR analysis PCR analysis of genomic DNA extracted from participants whole blood at month 0 n. 200 (DRF patients) 1b) To analyse for molecular biomarkers that may link with development of chronic pain and CRPS Biomarkers (including cytokines TNFα, Il-1 and IL-6, miRNA expression profiles miR-232 and miR-939 and autoantibodies) Biomarker analysis from whole blood samples taken at month 0 for all DRF patients and at month 6 for participants enrolled in sub-studies Month 0 n. 200 (DRF patients) Month 6 n. 50 - 94 (Sub-studies follow up participants) 1c) To compare genetic and molecular biomarker profiles from acute fracture cohort with those from an established chronic CRPS patient cohort Biomarkers (including cytokines TNFα, Il-1 and IL-6, miRNA expression profiles miR-232 and miR-939 and autoantibodies) Biomarker analysis from whole blood samples taken at month 0 n. 50 (chronic CRPS)
Neurobiology and Body Representation Disturbance (BRD)

2a) To identify predictive neural signatures in hypothesis-driven regions of interest (e.g. insula, parietal cingulate and ventral premotor cortices) Functional MRI Functional connectivity measures and Brain activation patters measured as Blood-Oxygen-Level-Dependent (BOLD) fMRI performed at month 0 and 6 n. 24 DRF

2:1 ratio between disturbed and normal body representation (16 BRD Vs 6 non-BRD

2b) To quantify the impact of BRD on pain severity, perception and quality of life in participants following a distal radius fracture Patient reported outcome measures (PROMS)
Bath CRPS Body Perception Disturbance Scale
Neglect-Like Questionnaire
Body disownership scale
Brief Pain Inventory
Fear of Pain Questionnaire - Short form
Pain Catastrophizing Scale
Pain Self Efficacy Questionnaire
Quick Disabilities of the Arm, Shoulder and Hand
Pittsburgh Sleep Quality Index
Edinburgh Handedness Index - Short Form
Hospital Anxiety and Depression Scale PROMS performed at month 0 for all DRF patients and at month 6 for participants enrolled in sub-studies Month 0 n. 200 (DRF) Month 6 n. 50 - 94 (Sub-studies follow up participants) 3. Heart rate variability (wearable digital technology) 3a) To analyse heart rate variability captured via remote wearable technology as a biomarker for predicting outcomes in baseline high vs low pain groups and recovery between high and low pain scores (VAS >6 and <3 respectively) Heart rate variability obtained from wearable device worn on non-fractured wrist for 5 days. Months 0 and 6 n. 50
1:1 ratio between numerical rating scale <3 and >6 (25 <3 Vs 25 >6) 4. Virtual Reality intervention feasibility 4a) To evaluate the feasibility, acceptability and preliminary influence on pain and body representation of a home-based virtual reality intervention. Self-reported feasibility and subjectivity questionnaire outcomes and digital wearable variables over 7-day regular usage period.

Patient reported outcome measures (PROMS)

Tampa Scale of Kinesiophobia
System Usability Scale
Virtual Reality Subjective Questionnaire
Subjective Experience Survey Month 6 n. 20 (BRD or pain persistence at 6 months)