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Trial registered on ANZCTR


Registration number
ACTRN12619001578190
Ethics application status
Approved
Date submitted
22/08/2019
Date registered
15/11/2019
Date last updated
15/11/2019
Date data sharing statement initially provided
15/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimal Pain Treatment Interventions (OPTIons): Providing early access to a specialist multidisciplinary pain service for people injured at work
Scientific title
Evaluation of Early Pain Management for Injured Workers at Risk of Developing Chronic Pain-Related Disability
Secondary ID [1] 298558 0
NIL
Universal Trial Number (UTN)
U1111-1235-7654
Trial acronym
Optimal Pain Treatment Interventions (OPTIons)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Work related soft tissue injuries 313383 0
pain 313384 0
Condition category
Condition code
Musculoskeletal 311821 311821 0 0
Other muscular and skeletal disorders
Injuries and Accidents 311839 311839 0 0
Other injuries and accidents
Anaesthesiology 312956 312956 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
OPTIons (Comprehensive Early Intervention)

Assessment:
Participants in the intervention cohort will undergo a comprehensive 5-hour assessment by a multidisciplinary team including a clinical psychologist, physiotherapist and pain specialist, at one of the Pain Management Clinics (PMC) involved in this study. This assessment determines specific treatment needs, as well as intensity. Participants will then be allocated to commence one of three levels of pain management programs, dependent on their Örebro score, use of opioids and time off work (see 'Triage Rules' below). All decisions regarding suitability for the various levels of intensity need to be flexible and assessed on a case by case basis, using the criteria as a guide rather than as absolute specifications. The underlying principle is to match the patient’s needs with the type of program.

Triage rules for High, Medium, Low intensity program, following multidisciplinary assessment:
• High intensity: Örebro >/= 50 with: opioid use >90 days (>60 mg morphine equivalent dose); or high complexity as determined by ePPOC scores; or polypharmacy use
• Medium intensity: Örebro >/= 50 with: opioid use >20 days (<80 mg morphine equivalent dose); or not prescribed opioids but have not returned to work after 12 weeks; or referred from low intensity intervention as needing additional support
• Low intensity: Örebro >/= 50 with: no opioids or regular medications and/or returned to work or off work for <12 weeks

Treatment:
The pain management programs will be carried out as per standard practice (see Components of Pain Management Programs, below).
OPTIONS Pain Management Programs Description:
• The High intensity program involves attending a multidisciplinary program five days a week for three weeks (about 105 hours contact). Workers will be encouraged to return to work (RTW) in the weeks following the program.
• The Medium intensity program involves attending a multidisciplinary program for five days in the first week and two days a week over the next two weeks (about 50 hours contact). Workers will be encouraged to RTW during the second or third week of the program.
• The Low intensity program involves attending a group program for two hours a week for five weeks or up to 10 individual sessions with a clinical psychologist and physiotherapist (about 10 hours contact). Workers will be encouraged to RTW during this period.

All levels of treatment involve interactive sessions, group or individual, cognitive behavioural therapy, with physiotherapy directed exercises employing CBT principles, home practice of the self-management skills and activities planned. Exercises include stretch exercises, aerobic and anaerobic exercises gradually upgraded according to pacing principles on an individual basis.

Each participant will have a workbook to record his/her exercise, activity, medication use, relaxation practice, use of problem-solving skills. Attendance will be recorded for all participants by the treatment team.

In addition to the treatment program, the intervention includes liaison by the PMC with the employer, via a rehabilitation provider or RTW coordinator and their GP. This will ensure a suitable return to work plan is in place for the worker to follow either during or at the completion of the treatment program. In all three programs the worker will be asked to meet with their GP during the pain treatment program to review their work capacity and to guide the return to work planning.

Key Components of Pain Management Programs:
Key content elements, as defined by the Agency for Clinical Innovation (ACI) in "Which patient for which program",(1) within the framework of RTW, include:
• education about chronic pain
• identified psychosocial barriers for returning to work
• communication regarding chronic pain in the workplace
• managing distress (depressed mood, anxiety, fears of re-injury or pain)
• managing flare-ups in pain at work and home
• applying problem solving in the workplace
• pacing up activity levels and tasks in the workplace
• withdrawal from analgesic medications (reduction schedule in the context of work).

Medium and High intensity Pain Management Programs also have the following features:
• offered within the context of a RTW plan
• delivered in less than six weeks
• a proficient multidisciplinary team is available to deliver the program in a coordinated, interdisciplinary manner
• effective liaison and coordination with any existing service providers, workplace rehabilitation providers, employer and RTW coordinators (which may or may not need to continue as part of the treatment plan)
• minimum in-house staffing complement, including: psychologist, physiotherapist (or occupational therapist/exercise physiologist), nurse (or pharmacist), pain medicine specialist (if medication withdrawal is included)
• musculoskeletal expertise through skilled physiotherapists and pain medicine specialists, and consideration of any further expertise (such as rheumatology, neurology or sports physicians) as part of the detailed design planning phase

1. ACI Pain Management Network. Pain Management Programs – Which Patient for Which Program? A guide for NSW Tier 3 and Tier 2 public health facilities providing pain programs. ISBN: 978-1-74187-936-0. https://www.aci.health.nsw.gov.au/__data/assets/pdf_file/0015/205071/ACI13-015-pain-programs-2017-web.pdf
Intervention code [1] 314823 0
Treatment: Other
Comparator / control treatment
Workers in the control will receive treatment by their GP (NTD: nominated treating doctor) as per usual via the usual workers compensation process but with the addition of a screening questionnaire for determining their eligibility. The treatment type and timing of their treatment will be determined by their NTD. This is standard practice.
The control group will not be offered the intervention as they will be followed up for 1 year, but if their doctor thinks it appropriate, they could be referred to a pain service at any time.
The trial intervention is already available to the general public as an intensive pain management program carried out at Specialist Pain Centres around Australia.
Control group
Active

Outcomes
Primary outcome [1] 320509 0
The primary outcome measure, is 'lost time from work' (in days) for up to 1 year after the Worker's injury, as assessed by number of days reimbursed for missing work. This information will be obtained from the insurer.
Timepoint [1] 320509 0
This is assessed at 12 months post date of injury.
Secondary outcome [1] 371851 0
Change in opioid use as assessed via a participant diary.
This secondary measure comes from the Electronic Persistent Pain Outcomes questionnaires (ePPOC).
Timepoint [1] 371851 0
Participants will complete a medication diary at four time points: (1) initial consent/assessment (baseline), (2) 3 months from baseline, (3) 6 months from baseline, and (4) 12 months from baseline.
Secondary outcome [2] 371852 0
Brief Pain Inventory (BPI; Cleeland et al., 1994): To measure pain intensity and interference.
Timepoint [2] 371852 0
This will be collected at four time points: (1) initial consent/assessment (baseline), (2) 3 months from baseline, (3) 6 months from baseline, and (4) 12 months from baseline.
Secondary outcome [3] 371853 0
Depression Anxiety Stress Scales (DASS-21; Lovibond & Lovibond, 1995): Depression severity sub-scale.
Timepoint [3] 371853 0
This will be collected at four time points: (1) initial consent/assessment (baseline), (2) 3 months from baseline, (3) 6 months from baseline, and (4) 12 months from baseline.
Secondary outcome [4] 371854 0
Pain Self-Efficacy Questionnaire (PSEQ; Nicholas et al., 2007): Measures the extent to which a person believes they can manage their pain.
Timepoint [4] 371854 0
This will be collected at four time points: (1) initial consent/assessment (baseline), (2) 3 months from baseline, (3) 6 months from baseline, and (4) 12 months from baseline.
Secondary outcome [5] 371855 0
Pain Catastrophizing Scale (PCS; Sullivan et al., 2001): Measures the extent to which someone believes the worst will occur from their pain symptoms.
Timepoint [5] 371855 0
This will be collected at four time points: (1) initial consent/assessment (baseline), (2) 3 months from baseline, (3) 6 months from baseline, and (4) 12 months from baseline.
Secondary outcome [6] 371856 0
Quality of Life Scale (AQoL-8D; Ware et al., 2008): This a multi-attribute utility quality of life instrument designed for use in economic evaluation studies. This instrument has 35 items in 8 separately scored dimensions; independent living, relationships, mental health, coping, pain, senses, self-worth and happiness.
Timepoint [6] 371856 0
This will be collected at four time points: (1) initial consent/assessment (baseline), (2) 3 months from baseline, (3) 6 months from baseline, and (4) 12 months from baseline.
Secondary outcome [7] 371857 0
Work Productivity and Activity Impairment Questionnaire: Specific Health Problem V2.0 (WPAI:SHP; Reilly et al., 1993): This instrument measures the time away from work because of the work injury and its effect on productivity while at work. This outcome is expressed as impairment percentage, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. An overall work productivity score will be calculated.
Timepoint [7] 371857 0
This will be collected at four time points: (1) initial consent/assessment (baseline), (2) 3 months from baseline, (3) 6 months from baseline, and (4) 12 months from baseline.
Secondary outcome [8] 371859 0
Total cost of claim for up to 1 year after the Worker's injury,including wage replacement, treatment costs, costs to workers. This information will be obtained from the insurer.
Timepoint [8] 371859 0
This is assessed at 12 months post date of injury.
Secondary outcome [9] 376732 0
Depression Anxiety Stress Scales (DASS-21; Lovibond & Lovibond, 1995): Anxiety severity sub-scale
Timepoint [9] 376732 0
This will be collected at four time points: (1) initial consent/assessment (baseline), (2) 3 months from baseline, (3) 6 months from baseline, and (4) 12 months from baseline.

Eligibility
Key inclusion criteria
The key inclusion criteria are:
• Having a current workers compensation claim
• Having a musculoskeletal injury
• Being unfit for work or Not returned to pre-injury duties and capacity (as per the Certificate of Capacity)
• Living in an identified postcode, which is close to a participating Pain Management Clinic
• Having a score of 50/100 or greater on the Örebro Musculoskeletal Pain Screening Questionnaire (*ÖMPSQ) OR currently using opioids for pain
• Within 14 to 90 days of the Worker having notified iCare about the injury
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria are:
• Being considered for surgery (scheduled or definite booking pending)
• Having a primary psychological injury
• Having a catastrophic injury (e.g. spinal cord injury)
• Having an injury due to assault
• Being a casual, contracted or labour-hire worker who could be job detached (where their contract has expired and/or there is no job to return to).
• Having concurrent claims where the worker already has an open claim when the new injury occurs.

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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Controlled prospective design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will be reporting descriptive statistics regarding demographic variables, as well as measures of psychological status, pain-related disability, and medication use for each participant. The main analysis involves comparing between both groups on duration of lost time from work.
The sample size estimation for this study is based upon a prior study (WISE; Nicholas et al., in press), which compared a brief psychological intervention for recently injured workers employed by NSW Health vs standard care. It reported effect sizes of d = .39 for the primary outcome (of work loss timein days), indicating that the intervention was effective. Based on this effect size, d = 0.39, alpha of .05 and 80% power, a sample of N = 208 workers will be adequate (n = 104 per group). As some may be lost due to attrition during the study, to be certain we can detect any effect, we are aiming to recruit N = 300 (150 control; 150 intervention). A sample size of 50 intervention participants at each site is considered feasible (N = 150 intervention), based on resources at each clinic and the two-year study duration.
The main analysis for this study will compare OPTIons vs. standard care cost per claim and days to return to work. We will replicate the previous analysis strategy used in the WISE study. That is, independent samples t-tests were used to compare costs and duration before RTW over the 12 months duration of the study.
The outcome data will be analysed using an intention-to-treat approach by a statistician who is blinded to group allocation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/12/2019
Actual
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14059 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 14060 0
St George Hospital - Kogarah
Recruitment hospital [3] 14140 0
Innervate Pain Management - Broadmeadow
Recruitment postcode(s) [1] 26850 0
2065 - St Leonards
Recruitment postcode(s) [2] 26851 0
2217 - Kogarah
Recruitment postcode(s) [3] 26952 0
2292 - Broadmeadow

Funding & Sponsors
Funding source category [1] 303121 0
Charities/Societies/Foundations
Name [1] 303121 0
icare foundation
Country [1] 303121 0
Australia
Primary sponsor type
University
Name
Sydney Medical School (Northern) - The University of Sydney
Address
The University of Sydney
Royal North Shore Hospital
Reserve Rd, St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 303117 0
Government body
Name [1] 303117 0
Agency for Clinical Innovation (ACI)
Address [1] 303117 0
Street Address:
Level 4, 67 Albert Avenue
Chatswood NSW 2067

Postal Address:
PO Box 699
Chatswood NSW 2057
Country [1] 303117 0
Australia
Other collaborator category [1] 280815 0
University
Name [1] 280815 0
Macquarie University
Address [1] 280815 0
GenIMPACT: Centre for Economic Impacts of Genomic Medicine
Level 3, 4 Eastern Road
Macquarie University, NSW 2109, Australia
Country [1] 280815 0
Australia
Other collaborator category [2] 280816 0
University
Name [2] 280816 0
The University of Sydney
Address [2] 280816 0
The University of Sydney, Pain Management Research Institute
Faculty of Medicine and Health
Ground Floor, Douglas Building
Royal North Shore Hospital
St Leonards, Sydney NSW 2065
Country [2] 280816 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303644 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 303644 0
Ethics committee country [1] 303644 0
Australia
Date submitted for ethics approval [1] 303644 0
30/08/2018
Approval date [1] 303644 0
10/10/2018
Ethics approval number [1] 303644 0
RESP/18/246
Ethics committee name [2] 303672 0
Human Sciences and Humanities Human Research Ethics Committee (EC00124)
Ethics committee address [2] 303672 0
Ethics committee country [2] 303672 0
Australia
Date submitted for ethics approval [2] 303672 0
31/07/2019
Approval date [2] 303672 0
11/10/2019
Ethics approval number [2] 303672 0
52019562498285

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94374 0
Prof Michael Nicholas
Address 94374 0
Director, Pain Education & Pain Management Programs
The University of Sydney, Pain Management Research Institute
Faculty of Medicine and Health
Ground Floor, Douglas Building
Royal North Shore Hospital
St Leonards, Sydney NSW 2065
Country 94374 0
Australia
Phone 94374 0
+61 2 9463 1515
Fax 94374 0
Email 94374 0
michael.nicholas@sydney.edu.au
Contact person for public queries
Name 94375 0
Lisa Daniela Vaccaro
Address 94375 0
The University of Sydney, Pain Management Research Institute
Faculty of Medicine and Health
Ground Floor, Douglas Building
Royal North Shore Hospital
St Leonards, Sydney NSW 2065
Country 94375 0
Australia
Phone 94375 0
+61 2 9463 1512
Fax 94375 0
Email 94375 0
lisa.vaccaro@sydney.edu.au
Contact person for scientific queries
Name 94376 0
Michael Nicholas
Address 94376 0
Director, Pain Education & Pain Management Programs
The University of Sydney, Pain Management Research Institute
Faculty of Medicine and Health
Ground Floor, Douglas Building
Royal North Shore Hospital
St Leonards, Sydney NSW 2065
Country 94376 0
Australia
Phone 94376 0
+61 2 9463 1515
Fax 94376 0
Email 94376 0
michael.nicholas@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be disseminated via peer-reviewed publications and at academic conferences. Data may also be disseminated in reports (e.g., to NSW Health). All data for these purposes will be de-identified and only sample means will be reported.


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.