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Clinical Trials/NCT07237152
NCT07237152Not yet recruitingNot Applicable

Risk Factors for Chronic Limb Pain in Major Trauma Patients With Limb Injury

University of Nottingham1 site in 1 country450 target enrollmentStarted: December 1, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
450
Locations
1
Primary Endpoint
Presence of chronic pain

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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