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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] 312494 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent post-surgical pain 334354 0
Persistent post-traumatic injury pain 334896 0
Condition category
Condition code
Anaesthesiology 330999 330999 0 0
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] 329015 0
Treatment: Other
Intervention code [2] 329016 0
Rehabilitation
Intervention code [3] 329017 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338767 0
Feasibility of a novel Multidisciplinary Transitional Pain Management Clinic - enrolment and completion.
Timepoint [1] 338767 0
Baseline, ie on participant discharge from hospital.
1-month 2-months and 3-months post discharge from hospital.
Primary outcome [2] 340165 0
Feasibility of a novel Multidisciplinary Transitional Pain Management Clinic - patient satisfaction.
Timepoint [2] 340165 0
At end of intervention, 3 months post discharge from hospital.
Secondary outcome [1] 437381 0
Patient-reported pain associated disability
Timepoint [1] 437381 0
Baseline (at discharge from hospital)
3-months, 6-months and 12-months post discharge from hospital
Secondary outcome [2] 443105 0
Opioid and other analgesic medication use
Timepoint [2] 443105 0
Baseline (at discharge from hospital)
3-months, 6-months and 12-months post discharge from hospital
Secondary outcome [3] 443107 0
Healthcare utilization
Timepoint [3] 443107 0
Baseline (at discharge from hospital)
3-months, 6-months and 12-months post discharge from hospital
Secondary outcome [4] 443108 0
Depression, anxiety and stress
Timepoint [4] 443108 0
Baseline (at discharge from hospital)
3-months, 6-months and 12-months post discharge from hospital
Secondary outcome [5] 443110 0
Pain self-efficacy
Timepoint [5] 443110 0
Baseline (at discharge from hospital)
3-months, 6-months and 12-months post discharge from hospital
Secondary outcome [6] 443113 0
Pain catastrophising
Timepoint [6] 443113 0
Baseline (at discharge from hospital)
3-months, 6-months and 12-months post discharge from hospital
Secondary outcome [7] 443114 0
Fear-avoidance behaviour
Timepoint [7] 443114 0
Baseline (at discharge from hospital)
3-months, 6-months and 12-months post discharge from hospital

Eligibility
Key inclusion criteria
Participants will include those who are 18 years and over, are patients of the St Vincent’s Hospital Acute Pain Service (APS), and meet the one or more of the following eligibility criteria:

Patients with a history of preadmission chronic pain conditions
Patients with a history of pre-admission opioid use <60mg oral morphine equivalents (OMEDD) as calculated by the ANZCA Faculty of Pain Medicine Opioid Calculator
Severe pain during hospital admission as assessed by the APS
High opioid consumption on discharge, >90mg OMEDD
Patients discharged with a prescription for long-acting opioid preparations
Psychological risk factors including depression, anxiety, pain catastrophizing, and kinesiophobia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants currently receiving opioid maintenance therapy (e.g. buprenorphine or methadone)
Patients with active substance use disorder or dependence
Pre-admission opioid use >60mg OMEDD
Participants with psychotic mental health disorders, or extremely severe depression

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics on the number of patients referred to the Transitional Clinic, number of initial appointments offered, number of initial appointments attended, and the number of scheduled appointments that were not attended, and participants' responses to the Patient Satisfaction Survey will be utilised to evaluate feasibility and acceptability. Descriptive statistics on additional clinician time for administrative processes (e.g. organising appointments, following up patients) will also be used to evaluate feasibility.

The mean difference between baseline, 3-month, 6-month, and 12-month follow ups will be examined across all key outcomes to explore any changes over the course of treatment and follow up.

The Unidisciplinary Transitional Pain Clinic typically sees 120 patients per year, therefore a representative sample of 60 participants was chosen for this pilot study to determine feasibility and acceptability in a 6-month recruitment period.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/01/2025
Actual
Date of last participant enrolment
Anticipated
16/06/2025
Actual
Date of last data collection
Anticipated
15/06/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26774 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 42825 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 316914 0
Charities/Societies/Foundations
Name [1] 316914 0
St Vincent's Curran Foundation
Country [1] 316914 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Sydney
Address
Country
Australia
Secondary sponsor category [1] 319162 0
None
Name [1] 319162 0
Address [1] 319162 0
Country [1] 319162 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315672 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 315672 0
https://svhs.org.au/home/research-education/research-office
Ethics committee country [1] 315672 0
Australia
Date submitted for ethics approval [1] 315672 0
28/01/2024
Approval date [1] 315672 0
25/04/2024
Ethics approval number [1] 315672 0

Summary
Brief summary
The study aims to explore the feasibility and acceptability of a new outpatient Transitional Pain Management Clinic at St Vincent's Hospital for participants with risk factors for ongoing pain and opioid use after surgery or injury. The intervention will include three sessions with a pain medicine physician and three sessions with a pain physiotherapist over a three month period post-discharge from hospital. The study will also evaluate the relationship between completion of the intervention at the Transitional Pain Management Clinic key outcomes including pain-associated disability, opioid use, and healthcare utilisation. It is anticipated that this clinic will be feasible to implement and acceptable to patients. Given that this clinic is aimed at prevention and early-intervention before the development of persistent postsurgical and posttraumatic pain, significant changes in key pain-associated outcomes are not necessarily anticipated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135454 0
Dr Martine O'Neill
Address 135454 0
St Vincent's Hospital Anaesthetic Department, 390 Victoria Street, Darlinghurst NSW 2010
Country 135454 0
Australia
Phone 135454 0
+61 2 8382 3204
Fax 135454 0
Email 135454 0
[email protected]
Contact person for public queries
Name 135455 0
Martine O'Neill
Address 135455 0
St Vincent's Hospital Anaesthetic Department, 390 Victoria Street, Darlinghurst NSW 2010
Country 135455 0
Australia
Phone 135455 0
+61 2 8382 3204
Fax 135455 0
Email 135455 0
[email protected]
Contact person for scientific queries
Name 135456 0
Martine O'Neill
Address 135456 0
St Vincent's Hospital Anaesthetic Department, 390 Victoria Street, Darlinghurst NSW 2010
Country 135456 0
Australia
Phone 135456 0
+61 2 8382 3204
Fax 135456 0
Email 135456 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.