Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000829718
Ethics application status
Approved
Date submitted
29/04/2022
Date registered
14/06/2022
Date last updated
13/04/2024
Date data sharing statement initially provided
14/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of multi-disciplinary pain management and motivational interviewing for people with chronic pain
Scientific title
In people with nociplastic dominant chronic pain is multi-disciplinary pain management plus motivational interviewing more effective than multi-disciplinary pain management alone for improving pain self-efficacy and pain interference: a randomised controlled trial
Secondary ID [1] 306552 0
Nil
Universal Trial Number (UTN)
Trial acronym
MI4Pain
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic musculoskeletal pain 325444 0
Condition category
Condition code
Musculoskeletal 322825 322825 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Both groups will receive a 12 week multi-disciplinary pain management program aiming to improve quality of life through a goal oriented graded activity/exercise program provided by registered medical, physiotherapy, psychology and dietitian practitioners with a special interest in chronic pain. There will be 12 individual psychology sessions (1 hour each), 16 group psychology sessions (2 x 60 minutes per week over the final 8 weeks), 32 x 45 minute individual physiotherapy sessions, 4 x 60 minute group dietitian sessions ± 4 x 30 minute individual dietitian sessions (if indicated), >4 x 30 minute individual medical sessions over 12 weeks. Group sessions would have no more than 10 participants. The program may be delivered face to face or via telehealth based on participant preference. Each session will focus on goal setting and scheduling activities and exercises that enable achievement of short, medium and long term goals. Common goals and associated activities would include hobbies (eg playing local football), relationships (eg communicating positively with partner over dinner) and work (eg returning to normal duties/hours). Common exercises would include walking and standing dumbbell exercises (eg bicep curl, squats, step ups). Biological, psychological and social barriers to achieving goals would be addressed through education and a cognitive behavioural approach. Adherence would be checked through electronic records of completed sessions as well as goal/rehabilitation sheet analysis tracking daily activity/exercise/goal achievement. Following discharge from the program there would be low frequency (typically monthly for 6 sessions) physiotherapy ± psychology/medical sessions up to 52 weeks to support achievement of long term goals. There would be no difference in the physiotherapy sessions between the control and intervention group apart from 10 of the sessions being conducted using an Motivational interviewing (MI) approach.

Motivational interviewing is a collaborative conversation style for strengthening a person’s own motivation and commitment to change. In the experimental group, the pain management physiotherapy component will be provided in accordance with the spirit of motivational interviewing micro-skills during processes of engagement, focusing, evoking and planning to increase goal oriented graded activity/exercise as well as address specific barriers to recovery. Ten of these sessions will have pre-determined foci, running for 45 minutes, commencing early in the program and continuing until the final session 24 weeks after discharge from the program. The sessions will aim to improve pain and activity limitation by way of greater self-efficacy in pain management participants, with better maintenance of treatment effects in the long-term.

Three sessions will then be conducted early in the pain management program (weeks 1, 2 and 4), with the goal of eliciting and strengthening an understanding of MI principles, the participant’s own values based goals, behaviour that address specific barriers to recovery and readiness to undertake a goal oriented graded activity/exercise. In the early to mid stages of the pain management program, the participant will commence a home based graded activity and clinic based supervised exercise program. Four sessions (weeks 5, 7, 9 and 12) will be conducted reviewing progress with this program and using MI communication skills and principles to elicit and strengthen graded progressions in activity/exercise. The sessions will also explore any challenges/barriers with the graded activity/exercise program and consider medium to longer term goals including return to work. Following discharge from the program three sessions (4, 11 and 25 weeks after discharge) will be conducted with the aim of supporting the ongoing goal oriented graded activity/exercise using MI skills and principles.

Physiotherapists will be trained before the trial from an experienced psychologist in motivational interviewing including group and one on one role play sessions. During the trial audio recordings of participant treatment will be randomly evaluated for each physiotherapist using the Motivational Interviewing Treatment Integrity (MITI) code for fidelity. Group and individual meetings between the psychologist and the physiotherapists ± top up training will be provided. Detailed clinical notes will be kept for both groups and evaluated by the researchers for congruence with the clinical protocol. Treatment receipt and enactment will be evaluated on a proportion of the sample for both groups.

Both groups will receive treatment individualised based on the participant's goals and the barriers to recovery identified by the practitioners.
Intervention code [1] 322979 0
Rehabilitation
Intervention code [2] 322980 0
Behaviour
Intervention code [3] 322981 0
Lifestyle
Comparator / control treatment
Both groups will receive a 12 week multi-disciplinary pain management program aiming to improve quality of life through a goal oriented graded activity/exercise program provided by registered medical, physiotherapy, psychology and dietitian practitioners with a special interest in chronic pain. There will be 12 individual psychology sessions, 16 group psychology sessions (2 per week over the final 8 weeks), 32 individual physiotherapy sessions, 4 group dietitian sessions ± 4 individual dietitian sessions (if indicated), >4 individual medical sessions over 12 weeks. Group sessions would have no more than 10 participants. The program may be delivered face to face or via telehealth based on participant preference. Each session will focus on goal setting and scheduling activities and exercises that enable achievement of short, medium and long term goals. Common goals and associated activities would include hobbies (eg playing local football), relationships (eg communicating positively with partner over dinner) and work (eg returning to normal duties/hours). Common exercises would include walking and standing dumbbell exercises (eg bicep curl, squats, step ups). Biological, psychological and social barriers to achieving goals would be addressed through education and a cognitive behavioural approach. Adherence would be checked through electronic records of completed sessions as well as goal/rehabilitation sheet analysis tracking daily activity/exercise/goal achievement. Following discharge from the program there would be low frequency (typically monthly for 6 sessions) physiotherapy ± psychology/medical sessions up to 52 weeks to support achievement of long term goals. There would be no difference in the physiotherapy sessions between the control and intervention group apart from 10 of the sessions being conducted using an MI approach.
Control group
Active

Outcomes
Primary outcome [1] 330609 0
Pain self-efficacy questionniare
Timepoint [1] 330609 0
52-weeks post randomisation
Primary outcome [2] 330610 0
Pain interference on the Brief Pain Inventory
Timepoint [2] 330610 0
52-weeks post randomisation
Secondary outcome [1] 406939 0
Brief Pain Inventory (pain interference)
Timepoint [1] 406939 0
12 and 26-weeks post randomisation
Secondary outcome [2] 406940 0
Pain Disability Questionnaire
Timepoint [2] 406940 0
26 and 52-weeks post randomisation
Secondary outcome [3] 406942 0
Depending on the location of the main pain area, one of the Oswestry Disability Questionnaire, the Neck Disability Index, the Upper Extremity Functional Index or the Lower Extremity Functional Index
Timepoint [3] 406942 0
26 and 52-weeks post randomisation
Secondary outcome [4] 406943 0
Depression Anxiety and Stress Scale
Timepoint [4] 406943 0
26 and 52-weeks post randomisation
Secondary outcome [5] 406946 0
Pain Self Efficacy Questionnaire
Timepoint [5] 406946 0
12 and 26-weeks post randomisation
Secondary outcome [6] 406948 0
Pain Catastrophising Scale
Timepoint [6] 406948 0
26 and 52-weeks post randomisation
Secondary outcome [7] 406950 0
Short Form Örebro Musculoskeletal Pain Screening Questionnaire
Timepoint [7] 406950 0
26 and 52-weeks post randomisation
Secondary outcome [8] 406952 0
Post Traumatic Stress Disorder Checklist - Civilian Version
Timepoint [8] 406952 0
26 and 52-weeks post randomisation
Secondary outcome [9] 406953 0
Insomnia Severity Index
Timepoint [9] 406953 0
26 and 52-weeks post randomisation
Secondary outcome [10] 406954 0
Pain related Beliefs and Attitudes about Sleep questionnaire
Timepoint [10] 406954 0
26 and 52-weeks post randomisation
Secondary outcome [11] 406955 0
Central Sensitisation Inventory
Timepoint [11] 406955 0
26 and 52-weeks post randomisation
Secondary outcome [12] 406956 0
Neuropathic Pain Questionnaire
Timepoint [12] 406956 0
26 and 52-weeks post randomisation
Secondary outcome [13] 406957 0
Alcohol Use Disorders Identification Test - Consumption questionnaire
Timepoint [13] 406957 0
26 and 52-weeks post randomisation
Secondary outcome [14] 406958 0
Drug Use Disorders identification Test - Consumption questionnaire
Timepoint [14] 406958 0
26 and 52-weeks post randomisation
Secondary outcome [15] 406959 0
Quality of life assessed using the EuroQoL-5D-5L questionnaire
Timepoint [15] 406959 0
26 and 52-weeks post randomisation
Secondary outcome [16] 406961 0
A Participant Diary to track healthcare, medication, and radiological imaging utilisation, as well as number of work days missed designed specifically for this study
Timepoint [16] 406961 0
26 and 52-weeks post randomisation
Secondary outcome [17] 406963 0
Satisfaction with treatment measured on a 5-point Likert Scale
Timepoint [17] 406963 0
26 and 52-weeks post randomisation
Secondary outcome [18] 406965 0
Treatment Credibility Questionnaire
Timepoint [18] 406965 0
26 and 52-weeks post randomisation
Secondary outcome [19] 406966 0
Participant compliance with treatment via the number of sessions attended based on structured clinical notes completed by the physiotherapist
Timepoint [19] 406966 0
26 and 52-weeks post randomisation
Secondary outcome [20] 406967 0
Global rating of change measured on a 7-point scale
Timepoint [20] 406967 0
26 and 52-weeks post randomisation
Secondary outcome [21] 408006 0
Brief Pain Inventory (Pain intensity)
Timepoint [21] 408006 0
26 and 52-weeks post randomisation
Secondary outcome [22] 409704 0
Participant compliance with treatment via a self-administered 0-10 rating scale
Timepoint [22] 409704 0
26 and 52-weeks post randomisation
Secondary outcome [23] 409723 0
The Motivational Interviewing Treatment Integrity code (MITI 4.2.1) will be used for mediation analyses
Timepoint [23] 409723 0
During intervention with one of the 10 sessions (excluding the initial session) randomly selected

Eligibility
Key inclusion criteria
On completion of baseline assessment, physiotherapists will discuss participation in the trial if participants meet the following inclusion criteria:
i. have a primary complaint of chronic musculoskeletal pain (of greater than 3 months duration)
ii. are presumed to have a pain type of nociplastic dominant pain;
iii. were referred for a multidisciplinary pain management program;
iv. are aged between 18 and 75 years;
v. have sufficient fluency in English to complete all baseline and follow up questionnaires;
vi. have a Pain Disability Questionnaire score measure of disability of at least 50/150; and a Numerical Pain Rating Scale score of at least 3/10, to ensure that Pain Management was indicated and that there was sufficient scope for improvement to be demonstrated.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will not be approached for consent if any of the following exclusion criteria are met, but reasons for exclusion will be recorded:
i. red flag pathologies unsuitable for pain management (active cancer, signs of cauda equina syndrome based on bladder or bowel disturbance, risk of spinal fracture, signs of potential infection, systemic inflammatory disease
ii. chronic cancer, pelvic or neuropathic (eg post herpatic neuralgia) pain;
iii. recent or pending surgery for the pain condition;
iv. pregnancy or childbirth within the last 6 months;
v. injections for the pain problem within the last 6 weeks, as we wish to study treatment effects independent to the effects of such procedures;
vi. have already received multi-disciplinary pain management for the main pain problem within the last 2 years, to avoid contamination.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
To enrol a participant, the treatment centre will email the consenting participant’s name and date of birth to an offsite randomisation service who will allocate the participant to a treatment group in accordance with the randomisation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation schedule for allocating participants to the two groups will be prepared in advance by an offsite researcher not involved in assessing, enrolling or treating the participants. Block randomisation (random block lengths), with stratification for treatment centre (5 levels) and primary pain site (5 levels: low back, neck, upper limb, lower limb, widespread) will be employed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data analysis will focus on detecting the between-group treatment effects at each follow-up. Analyses will be conducted using SPSS, with alpha set at 0.05 using a two-tailed hypothesis. Continuous data will be analysed using linear mixed models (with the group x time interaction estimating the treatment effect), adjusting for baseline scores and the stratification variables (treatment centre and primary pain site). Ordinal data will be analysed using the Mann Whitney U test.

All data will be analysed on an intention to treat basis. A within-trial cost-effectiveness analysis will be undertaken based on the EuroQol 5-D and healthcare utilisation data from the participant diary.

Treatment effect modifier analyses will determine participant characteristics at baseline who derive either a larger or smaller treatment effect from pain management plus motivational interviewing relative to pain management alone. The hypotheses to be tested will be that the greatest benefit from pain management plus motivational interviewing relative to pain management alone will be in participants with higher scores on one or more of the Short Form Örebro Musculoskeletal Screening Questionnaire and/or the Pain Disability Questionnaire and/or lower scores on the Pain Self Efficacy Questionnaire at baseline.

Mediator analyses will determine potential mechanisms of action for the motivational interviewing intervention evaluating:
1) Whether self-efficacy mediates the effect of motivational interviewing treatment on pain interference
2) Whether practitioner motivational interviewing behaviours as measured by the MITI mediate the effect of motivational interviewing treatment on self-efficacy and pain interference

If pre-planned modifier and mediation hypotheses do not result in statistically significant results, a data-driven approach will be employed to identify new hypotheses.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2022
Actual
3/11/2022
Date of last participant enrolment
Anticipated
30/10/2024
Actual
Date of last data collection
Anticipated
30/10/2025
Actual
Sample size
Target
184
Accrual to date
100
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 36907 0
3029 - Hoppers Crossing
Recruitment postcode(s) [2] 36908 0
3021 - St Albans
Recruitment postcode(s) [3] 36909 0
3083 - Bundoora
Recruitment postcode(s) [4] 36910 0
3155 - Boronia
Recruitment postcode(s) [5] 36911 0
3175 - Dandenong South

Funding & Sponsors
Funding source category [1] 310887 0
Commercial sector/Industry
Name [1] 310887 0
Advance Healthcare
Country [1] 310887 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Kingsbury Drive
Bundoora, Victoria 3083
Country
Australia
Secondary sponsor category [1] 312164 0
None
Name [1] 312164 0
Address [1] 312164 0
Country [1] 312164 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310447 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 310447 0
Ethics committee country [1] 310447 0
Australia
Date submitted for ethics approval [1] 310447 0
01/02/2021
Approval date [1] 310447 0
01/04/2021
Ethics approval number [1] 310447 0

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

Contacts
Principal investigator
Name 117702 0
A/Prof Jon Ford
Address 117702 0
Advance Healthcare
102 Frankston-Dandenong Road
Dandenong South, VIC 3175
Country 117702 0
Australia
Phone 117702 0
+61 422244183
Fax 117702 0
Email 117702 0
[email protected]
Contact person for public queries
Name 117703 0
Jon Ford
Address 117703 0
Advance Healthcare
102 Frankston-Dandenong Road
Dandenong South, VIC 3175
Country 117703 0
Australia
Phone 117703 0
+61 422244183
Fax 117703 0
Email 117703 0
[email protected]
Contact person for scientific queries
Name 117704 0
Jon Ford
Address 117704 0
Advance Healthcare
102 Frankston-Dandenong Road
Dandenong South, VIC 3175
Country 117704 0
Australia
Phone 117704 0
+61 422244183
Fax 117704 0
Email 117704 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Any de-identified data will be available to be shared on request
When will data be available (start and end dates)?
Data will be available following publication of the primary outcomes, until 7 years post-publication
Available to whom?
All researchers with a verifiable institutional profile and email address who requests access for a specific purpose
Available for what types of analyses?
Any analysis proposed by the requesting researcher will be considered
How or where can data be obtained?
Researchers will need to request access to the specific data elements they require for a specific project via the Principal Investigator ([email protected]), or the ethics committee. Following signing of a data sharing agreement between the parties, the required data will be released to the requesting researcher via secure email. Only de-identified data will be shared.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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