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RecruitingNCT07777081PERCIPIENTUpdated Aug 20, 2026

How the Brain and Body Recover After a Wrist Fracture

An observational study in Wrist Fracture and Complex Regional Pain Syndrome, sponsored by Cambridge University Hospitals NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Cambridge University Hospitals NHS Foundation Trust · Observational

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 10 studies in Wrist Fractures with a site in United Kingdom — 1 open to participants now, 2 under way, none of them phase 3. Wrist Fractures · United Kingdom.

Started
2026
the only one that year
Observational
5 of 10
1 open now
Registered
9th of 10
by date
Lead sponsor
1 of 10
Cambridge University Hospitals NHS Foundation Trust

Among the 10 studies in Wrist Fractures with a site in United Kingdom, this one is the only one that started in 2026, is one of 5 observational ones, and was the 9th registered.

Wrist Fractures

330 studies on the registry are indexed under Wrist Fractures; 72 are open to participants now.

Browse Wrist Fractures studies →

Open to participants now

1 of the 10 studies in Wrist Fractures with a site in United Kingdom is open now.

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 43 Wrist Fractures studies recruiting now, 20 (47%) set no upper age limit and 15 (35%) stop at 75 or younger; 7 take children under 18; 6 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies in Wrist Fractures with a site in United Kingdom, or all of them as a file.
02

Study 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
Read the 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

  1. Validate candidate genes and identify molecular biomarkers associated with pain persistence and development of CRPS
  2. To characterise the neurobiological and bodily representation changes that occur following a wrist fracture and their impact on the patient experience using fMRI
  3. Investigate autonomic nervous system function as a potential predictor of clinical outcomes using Wearable digital technology
  4. 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

  1. 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)
  2. 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)
03

Conditions studied

  • Wrist Fracture
  • Complex Regional Pain Syndrome

Keywords

  • Chronic pain
  • Body representation
  • post- wrist fracture
  • functional MRI
  • Genes
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with a single wrist fracture Patients with chronic CRPS

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Inability to understand the 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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Post-wrist fracture

    Blood sample for genetic analysis and other blood biomarkers

  • Post-wrist fracture with and without body scheme disruption

    For functional MRI scanning in participants with and without body scheme disruption

  • Patients with chronic CRPS

    Blood sample for genetic analysis and other blood biomarkers

  • Patients with chronic CRPS with body scheme disruption

    For functional MRI scanning in participants with CRPS

06

What researchers measure

Primary outcomes

  1. Rare SNPs in genetic analysis

    A whole blood sample will be collected from each participant at baseline. DNA will be analysis to identify the presence or absence of pre-specified candidate Single Nucleotide Polymorphisms (SNP) alleles, previously associated with chronic CRPS, via Polymerase Chain Reaction (PCR). Participants will then be categorised as variant positive or negative.

    Time frame: 5 years

Secondary outcomes

  1. Functional MRI biomarkers

    Structural and functional MRI scans will be performed at month 0 and 6 using 3T MRI facilities at the Wolfson Brain Imaging Centre in Cambridge. This will involve a 1-hour scanning time, including stuctural (T1-weighted and Diffusion Tensor Imaging (DTI)) and functional (task-based and resting-state BOLD) fMRI.

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • Addenbrooke's Hospital
    Cambridge, Cambridgeshire CB2 0QQ, United Kingdom
    Recruiting
    • Neal Chauhan, MBBS · Contactneal.chauhan@nhs.net · 01223 216182
    • Nicholas Shenker, BMBCh PhD · Contact
    • Neal Chauhan, MBBS · Sub investigator
    • Nicholas Shenker, BMBCh PhD · Principal investigator
08

References and documents

Publications

  • Shaikh SS, Goebel A, Lee MC, Nahorski MS, Shenker N, Pamela Y, Drissi I, Brown C, Ison G, Shaikh MF, Kuttikat A, Woods WA, Dixit A, Stouffer K, Clarke MC, Menon DK, Woods CG. Evidence of a genetic background predisposing to complex regional pain syndrome type 1. J Med Genet. 2024 Jan 19;61(2):163-170. doi: 10.1136/jmg-2023-109236. PubMed 37816627 ↗
  • Moseley GL, Herbert RD, Parsons T, Lucas S, Van Hilten JJ, Marinus J. Intense pain soon after wrist fracture strongly predicts who will develop complex regional pain syndrome: prospective cohort study. J Pain. 2014 Jan;15(1):16-23. doi: 10.1016/j.jpain.2013.08.009. Epub 2013 Nov 19. PubMed 24268113 ↗

Related links

Individual participant data

Plan to share: Undecided — Data may not be in an appropriate format to be shared

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Aug 2031, 60 months after the start.

Of 20 observational studies under Wrist Fractures, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 63. This study's planned 60 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2026
First posted
Aug 20, 2026
StartActual
Aug 12, 2026
Primary completionEst.
Aug 12, 2031
CompletionEst.
Aug 12, 2032
Last update
Aug 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07777081
Collaborators
University of Cambridge, Anglia Ruskin University
Responsible party
Dr Nicholas Shenker (Chief Investigator, Cambridge University Hospitals NHS Foundation Trust) — Principal investigator
First posted
Aug 20, 2026
Start date
Aug 12, 2026
Primary completion
Aug 12, 2031 (estimated)
Completion
Aug 12, 2032 (estimated)
Last update
Aug 20, 2026

Study contacts

Neal Chauhan, MBBS
Contact
neal.chauhan@nhs.net
01223 216182
Nicholas Shenker, BMBCh PhD
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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