ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12625000016437

Ethics application status

Approved

Date submitted

10/07/2024

Date registered

10/01/2025

Date last updated

10/01/2025

Date data sharing statement initially provided

10/01/2025

Type of registration

Prospectively registered

Titles & IDs

Public title

Multidisciplinary Treatment of Persistent Post-Surgical Pain

Scientific title

A Multidisciplinary Transitional Pain Management Clinic at St Vincent's Hospital for patients at risk of chronic post-surgical pain: a Pilot Programme

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Persistent post-traumatic injury pain

Persistent post-surgical pain

Condition category

Condition code

Anaesthesiology

Pain management

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This is a longitudinal pilot study aiming to assess the feasibility of a multidisciplinary Transitional Pain Management Service for participants discharged from St Vincent's Hospital Sydney following surgery or traumatic injury.

Participants with risk factors for persistent post-surgical or post-traumatic injury pain will be recruited from the Acute Pain Service as inpatients. They will then attend the outpatient St Vincent's Hospital Transitional Pain Management Service face-to-face or via Telehealth, attending three sessions each with a specialist pain medicine physician and a pain physiotherapist (at 1 month, 2 months and 3 months post discharge).

Specialist pain medicine physician consultations will be 30 minutes duration and include:

Assessment of biomedical recovery following surgery or injury:
- Full history and physical examination of relevant systems
- Detailed pain history including trajectory of acute pain, plus other chronic pain problems,
including numerical rating scale reports of worst, average and best pain
Assessment of biomedical complications:
- e.g Evidence of wound infection, thromboembolism, other post surgical complications
Assessment of medication use (including opioid medications):
- Both pre and post surgery/injury
Assessment of functional recovery in personal, employment, social domains:
- e.g. Assessment of personal and domestic activities of daily living, return to work, leisure activities
Assessment of mental health and substance use:
- e.g. Assessment of mood, anxiety, other mental health problems
- e.g. Assessment of interpersonal relationships
- e.g. Assessment of substance use including alcohol and tobacco
Referral to other health services if appropriate:
- e.g. To surgical teams if surgical complications, to mental health services if significant mood issues.
All sessions will be recorded by contemporaneous notes in the participant's medical file, and a letter outlining each consultation will be sent to their nominated primary care physician.

Physiotherapy sessions will 1 hour for the initial consultation and 30mins for subsequent consultations, and will be delivered by a specialized pain physiotherapist. Sessions will include:

Assessment and identification of risks or barriers that may hinder a return to presurgery/preinjury level of functioning, e.g:
- Fear avoidant behaviours
- Unhelpful motor patterns
- Anxiety with movement
- Unhelpful thinking patterns
- Sleep disturbance
- Lack of support from family and/or friends
- Home environment barriers e.g. no appropriate modifications or aids

Functional outcome measures as appropriate for each participant e.g:
- Timed up and go test (TUG)
- 6 minute walk test (6MWT)
- 30 second chair stand test (30 CST)
- Near tandem stance test
- Wall push ups in 1 min

Depending on individual participant context, other physiotherapy may include but is not limited to:
Pain education e.g:
- What to expect as recovery progresses, expectation setting regarding pain especially with
movement, non-pharmacological techniques to manage pain including pacing education,
modification of movement/use of aids and up-titration of activity as healing progresses
Exercise therapy:
- Exercise therapy will be trialed during the consultation and a smart watch will be worn by
the patient to ensure exercise intensity is under 70% of maximum heart rate
Balance training
Goal setting
- As per NSW Agency for Clinical Innovation SMART guidelines for goal setting
- https://aci.health.nsw.gov.au/chronic-pain/brain-injury/understanding-pain/goal-setting-
and-maintaining-the-changes
Relaxation therapy
Correcting unhelpful motor patterns
Addressing fear avoidant behaviours
Education on pacing
Education on scheduling daily activities appropriate to stage of recovery
Providing online/print resources
Sleep hygiene
General dietary advice
Referrals to other health professionals / services e.g:
- When a patient presents with any condition that is outside the scope of physiotherapy
practice such as undiagnosed fractures, tendon / ligament rupture, mental illness eg
depression.

To monitor adherence to the intervention, patients will complete an exercise recording sheet/ diary which will be assessed in subsequent sessions for issues/progress.

All physiotherapy sessions will be recorded by contemporaneous note taking in the patient's medical file.

Participants will be asked to complete online self-report questionnaires at baseline and 3-month, 6-month, and 12-month follow ups, which will include:
Demographic data
Medical history
Healthcare utilization
Medication use
Brief Pain Inventory (BPI)
Depression Anxiety Stress Scales (DASS21)
Pain Self-Efficacy Questionnaire
Pain Catastrophising Scale (PCS)
Tampa Scale of Kinesiophobia (TSK)

The questionnaires will take approximately 15-30 minutes to complete.

Intervention code [1]

Rehabilitation

Intervention code [2]

Treatment: Other

Intervention code [3]

Behaviour

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Feasibility of a novel Multidisciplinary Transitional Pain Management Clinic - enrolment and completion.

Timepoint [1]

Baseline, ie on participant discharge from hospital. 1-month 2-months and 3-months post discharge from hospital.

Primary outcome [2]

Feasibility of a novel Multidisciplinary Transitional Pain Management Clinic - patient satisfaction.

Timepoint [2]

At end of intervention, 3 months post discharge from hospital.

Secondary outcome [1]

Fear-avoidance behaviour

Timepoint [1]