Chronic PainCOPE: MTNCT07237152
Chronic Pain Predictors in Major Trauma
An observational study of Chronic Pain and Limb Fracture, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
The goal of this observational study is to learn about who is at risk of developing chronic pain in a major trauma population with at least one limb fracture. The main question it aims to answer is: which risk factors predict which patients will experience chronic pain following traumatic limb injury. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Chronic Pain, Limb Fracture
- How many people
- 450 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2025to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult major trauma patients with a minimum of one limb fracture treated at the East Midlands Major Trauma Centre based at Nottingham University Hospitals NHS Trust
Who may be able to join
- Aged ≥ 16 Polytrauma patient (multiple injuries affecting multiple body regions or organ systems) Admitted to a UK Major Trauma Centre Minimum of 1 radiologically confirmed traumatic limb fracture Have capacity to provide informed consent to participate in the study Have sufficient proficiency in English to provide the required data or be willing to use an approved interpreting service for data collection Recruited within 4 weeks of injury
Who cannot join
- No traumatic limb fracture Patients with a primary or treatment amputation in relation to their limb injury Pathological limb fractures Prisoners No fixed abode
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Queens Medical Centre- Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, NG7 2UH
Georgia E Melia, BSc (Hons), MRes, +44 0115 9249924 ext. 87070, georgia.melia1@nhs.net
About this study
Official title: Risk Factors for Chronic Limb Pain in Major Trauma Patients With Limb Injury
The goal of this observational study is to learn about who is at risk of developing chronic pain in a major trauma population with at least one limb fracture.
The main question it aims to answer is: which risk factors predict which patients will experience chronic pain following traumatic limb injury.
Participants will answer a baseline questionnaire and two outcome questionnaires about their pain at 3 and 6 months after their injury.
- Conditions
- Chronic Pain, Limb Fracture
- Keywords
- chronic pain, limb fracture, risk factors, prediction model
- Medical subject headings
- Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of chronic pain
Assessed using a 11-point numerical rating scale from 0 (no pain) - 10 (worst possible pain).
Measured: Reported at baseline, 3 and 6 months post-injury
Severity of chronic pain
Assessed using a 11-point numerical rating scale from 0 (no pain) - 10 (worst possible pain).
Measured: Reported at baseline, 3 and 6 months post-injury
Pain impact
Assessed using the six-item pain interference index
Measured: Reported at baseline, 3 and 6 months post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study startDec 2025 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denise Kendrick, Professor, Study director, Faculty of Medicine & Health Sciences University of NottinghamAdam Brooks, FRCS (Gen Surg), Principal investigator, Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237152
- Sponsor's protocol ID
- 25034
- Acronym
- COPE: MT
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Chronic Limb Pain in Major Trauma Patients With Limb Injury
- ClinicalTrials.gov ID
- NCT07237152
- Acronym / sponsor ID
- COPE: MT / 25034
- Conditions
- Chronic Pain, Limb Fracture
- Keywords
- chronic pain, limb fracture, risk factors, prediction model
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about who is at risk of developing chronic pain in a major trauma population with at least one limb fracture.
The main question it aims to answer is: which risk factors predict which patients will experience chronic pain following traumatic limb injury.
Participants will answer a baseline questionnaire and two outcome questionnaires about their pain at 3 and 6 months after their injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult major trauma patients with a minimum of one limb fracture treated at the East Midlands Major Trauma Centre based at Nottingham University Hospitals NHS Trust
Key inclusion criteria (1 listed)
- Aged ≥ 16 Polytrauma patient (multiple injuries affecting multiple body regions or organ systems) Admitted to a UK Major Trauma Centre Minimum of 1 radiologically confirmed traumatic limb fracture Have capacity to provide informed consent to participate in the study Have sufficient proficiency in English to provide the required data or be willing to use an approved interpreting service for data collection Recruited within 4 weeks of injury
Key exclusion criteria (1 listed)
- No traumatic limb fracture Patients with a primary or treatment amputation in relation to their limb injury Pathological limb fractures Prisoners No fixed abode
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of chronic pain
Time frame: Reported at baseline, 3 and 6 months post-injury
Assessed using a 11-point numerical rating scale from 0 (no pain) - 10 (worst possible pain).
Severity of chronic pain
Time frame: Reported at baseline, 3 and 6 months post-injury
Assessed using a 11-point numerical rating scale from 0 (no pain) - 10 (worst possible pain).
Pain impact
Time frame: Reported at baseline, 3 and 6 months post-injury
Assessed using the six-item pain interference index
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Denise Kendrick, Professor study director
Faculty of Medicine & Health Sciences University of Nottingham
Adam Brooks, FRCS (Gen Surg) principal investigator
Nottingham University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Limb Fracture, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Georgia E Melia, BSc (Hons), MRes (+44 0115 9249924 ext. 87070, georgia.melia1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of chronic pain (time frame: Reported at baseline, 3 and 6 months post-injury). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.