Cohort Observation study of Pain in Extremity Trauma

This is a multicentre study of early and persistent pain after tibial injuries.

Chief Investigator: Mr Shehan Hettiaratchy, Sponsored by Imperial College Healthcare NHS Trust.

Pain after severe injury can limit patients’ recovery and has been raised as a concern by patient groups. Chronic pain can have a major personal impact whilst at a societal level it poses a significant socioeconomic burden. This study aims to determine the incidence, impact and describe the nature of chronic pain after lower leg trauma, using fractures of the tibial diaphysis (shaft) as a model.

TITLE

A Multicentre Cohort Observational Study of Pain in Extremity Trauma (COPET)

DESIGN

Observational cohort study

AIMS

To determine the incidence and natural history nerve dysfunction and chronic pain in extremity trauma

OUTCOME MEASURES

Incidence of peripheral nerve dysfunction

Incidence and severity of acute nociceptive and neuropathic pain

Incidence and severity of chronic nociceptive and neuropathic pain

Participant recruitment feasibility

POPULATION

Adults over 16 years old with fractures of the tibial diaphysis (AO classification 42 A-C 1-3) with or without soft tissue injury.

ELIGIBILITY

Age ≥16 year.

Adequate understanding of English for comprehension of study questionnaires.

Isolated open or closed fracture of the tibial diaphysis (shaft) meeting AO classification 42 (A1-3, B1-3, C1-3) with or without soft tissue injury.

Within 48 hours of arrival in hospital.

Duration

6 months recruitment, 12 months follow up

Trial status

  • Closed to recruitment Feb 2019 across all sites
  • Recruited 66 participants (target 60)
  • Initial data being collated from sites​

Pre-work leading to study has been published here. Reference: Prinsloo F, Flynn C, Prime M, Wickham A & Hettiaratchy S. The incidence of chronic pain following tibial diaphyseal fracture. J Trauma Crit Care 2019;3(1): 6-11.​

For more information email COPETStudy@gmail.com

 

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