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Early intervention pathway for major trauma patients at risk of developing persistent pain

To determine if a multidisciplinary early intervention for major trauma leads to a change in health-related quality-of-life at 12-months (assessed using EQ-5D5L) when compared to usual care for major trauma patients at risk of developing persistent pain

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625001116415
Enrollment
96
Registered
2025-10-13
Start date
2025-10-15
Completion date
2026-09-22
Last updated
2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Persistent pain after traumatic injury can significantly affect a person’s recovery and their long-term physical and social wellbeing. This project aims to find out whether an early, coordinated, multidisciplinary approach to care can lead to better outcomes for people with post-trauma pain. The study will also explore whether participants and their caregivers found the intervention easy to take part in and worth doing.

Interventions

Structure of interventions Inpatient education comprising of a short message about recovery from trauma delivered by a healthcare professional in audio format. It will introduce themes outlined below. Four x 1 hour 1:1 consultations with a psychologist with specialist pain medicine physician support and review that occur every other week for four sessions (6 weeks total) Inpatient education will address: • Basic pain physiology, including pain as danger detector / protector • Difference betwee

Structure of interventions Inpatient education comprising of a short message about recovery from trauma delivered by a healthcare professional in audio format. It will introduce themes outlined below. Four x 1 hour 1:1 consultations with a psychologist with specialist pain medicine physician support and review that occur every other week for four sessions (6 weeks total) Inpatient education will address: • Basic pain physiology, including pain as danger detector / protector • Difference between acute and persistent pain and structural and non-structural pain • Danger/Safety framework and role of attentional system • Drivers of danger include – unclear diagnosis, fear about pain and its trajectory, compensation stress, perceptions of injustice, hx of trauma • Drivers of safety include – understanding of pain and diagnosis, feeling supported, recovery pathway including optimisation and facilitation of claim • Introduction/rationale for understanding pain, activity pacing, gentle movement, relaxation and mindfulness • Introduction to strategies to manage pain including opioids, anti-inflammatories and nerve modulating medications 5-10-minute video outlining practical aspects of injury/trauma recovery: • Role of pain medicine, rehabilitation medicine, co-ordinating GP • What to expect re health processes: specialist appointments, need for certificates • Compensable systems including Transport Accident Commission (TAC), Worksafe (WCA) claim processes, contacts, supports, troubleshooting Interventional content – in person or telehealth Session 1 - Psychology or Physiotherapy lead • Assessment session (physiotherapy or psychology lead) with brief medical review including diagnosis, stage of recovery, consolidation and ensuring shared understanding of presenting issues and treatment rationale • Ascertain key targets for intervention and SMART goals Session 2 - Psychology lead • Review TAC claim process/coordination of care • Introduction to Window of Tolerance – for understanding mind/body stress response and emotional regulation • Noticing and responding to catastrophic /fear cognitions • Skill building: somatic-tracking + grounding i.e. tuning into / tolerating unpleasant sensations • Homework practice: Mindfulness exercise: “when pain grabs your attention” Session 3 - Physiotherapy lead • Mindful movement – encouraging safety in the body • Activity pacing • Homework practice: Completing valued activity applying mindfulness and pacing principles Session 4 – Psychology or Physiotherapy lead • Review of progress and sessions to date • Review of claims process • Post-discharge medical/nursing summary, goal setting w community links, follow-up plans • Relapse prevention/planning - Adherence will be monitored through patient attendance to sessions - Adherence may also be monitored through recollection of themes checked by psychologist at beginning of each session - Adherence may also be monitored through web-portal analytics for engagement in disseminated communication and filling in PROMs in a timely fashion if able to do so.

Sponsors

Royal Melbourne Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Patients: Any trauma patient at RMH aged 18-65 years old receiving consult services from either the trauma unit and/or the acute pain service who has a high pain report. The patients must have an injury severity score (ISS) >15 (definitive for major trauma) to qualify. Clinicians: All clinicians taking part in the project (both intervention and control arms) will be eligible to participate in the qualitative component.

Exclusion criteria

Major head injury: Failure of post traumatic amnesia testing for >3 days. Active psychosis: noted to be psychotic at admission or referral to consultation liaison psychiatry for assessment and management of suspected psychosis. High-risk ongoing suicidality. Active or uncontrolled substance use disorder. Patients unable to converse fluently in English will be excluded, as effective communication is essential for participation. However, individuals who speak English as a second language but are fluent are eligible.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026