Chronic Pain Predictors in Major Trauma (COPE: MT)

November 14, 2025 updated by: University of Nottingham

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
        • Queens Medical Centre- Nottingham University Hospitals NHS Trust
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

No traumatic limb fracture Patients with a primary or treatment amputation in relation to their limb injury Pathological limb fractures Prisoners No fixed abode

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Reported at baseline, 3 and 6 months post-injury
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).
Reported at baseline, 3 and 6 months post-injury
Pain impact
Time Frame: Reported at baseline, 3 and 6 months post-injury
Assessed using the six-item pain interference index
Reported at baseline, 3 and 6 months post-injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Investigators

  • Study Director: Denise Kendrick, Professor, Faculty of Medicine & Health Sciences University of Nottingham
  • Principal Investigator: Adam Brooks, FRCS (Gen Surg), Nottingham University Hospitals Nhs Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 19, 2025

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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