Chronic Pain Predictors in Major Trauma

NCT07237152 | Not Yet Recruiting

• 1 other identifier: 25034
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (3)

• Presence of chronic pain

  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

  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

  Assessed using the six-item pain interference index

  Reported at baseline, 3 and 6 months post-injury

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Queens Medical Centre- Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Denise Kendrick, Professor

  Faculty of Medicine & Health Sciences University of Nottingham

  STUDY DIRECTOR

• Adam Brooks, FRCS (Gen Surg)

  Nottingham University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgia E Melia, BSc (Hons), MRes

CONTACT

+44 0115 9249924; georgia.melia1@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-10

Locations

GB (1)