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Trial registered on ANZCTR


Registration number
ACTRN12624000743561
Ethics application status
Approved
Date submitted
10/05/2024
Date registered
14/06/2024
Date last updated
14/06/2024
Date data sharing statement initially provided
14/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of adding an additional intervention to a pain management program in people with chronic low back pain
Scientific title
In people with nociceptive or neuropathic dominant chronic low back pain, is multi-disciplinary pain management plus motor control training individualised for the spine (MInS) more effective than multi-disciplinary pain management alone for improving activity limitation
Secondary ID [1] 312119 0
Nil
Universal Trial Number (UTN)
Trial acronym
MInS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain with predominant features of nociceptive or neuropathic pain 333764 0
Condition category
Condition code
Musculoskeletal 330440 330440 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 330655 330655 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Both groups will receive a 12-14 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 approximately 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 in both groups 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 between groups include walking and standing functional exercises (eg bicep curls, front raises, 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. Both groups will receive treatment based on the participant's goals and the barriers to recovery identified by the practitioners.

The difference between the groups relates to the approach used in the physiotherapy sessions (both in the 12 week program and in sessions up to 52 weeks) whereby the intervention group will include the provision of specific training to optimise posture, movement and muscle activation in low load positions, prior to commencement of upright functional exercises) and subsequently integrated in daily activities (Hodges 2013). The exercises chosen as part of the MInS intervention will depend on the patient's presenting problems and functional task goals, and will be chosen by the individual therapist after a structured and detailed assessment of posture, movement and muscle activation while completing various functional tasks. There is no standard set of exercises for practitioners to choose from in the MInS intervention, and the dosages will vary based on the results of the detailed assessment of posture, movement and muscle activation (ie. this cannot be outlined a priori given it is individualised). The number and length of physiotherapy sessions will be similar between groups (as outline above), with the MInS treatment integrated within those standard sessions. Intervention (MInS) group practitioners will be trained before the trial commences according to a specific clinical protocol including assessment of competency prior to providing treatment to intervention group participants.
Intervention code [1] 328557 0
Rehabilitation
Comparator / control treatment
Standard multidisciplinary pain management, defined as a 12-14 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 approximately 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 between groups include walking and standing functional exercises (eg bicep curls, front raises, 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. Both groups will receive treatment based on the participant's goals and the barriers to recovery identified by the practitioners. The control group will not receive specific exercises or training related to their posture, movement and muscle activation prior to the commencement of common functional restoration exercises, instead only completing the common exercises above related to functional restoration. The number and length of physiotherapy sessions will be similar between groups.
Control group
Active

Outcomes
Primary outcome [1] 338195 0
Activity limitation
Timepoint [1] 338195 0
26 weeks post randomisation
Secondary outcome [1] 434891 0
Activity limitation
Timepoint [1] 434891 0
Baseline, and at 12 weeks and 52-weeks post randomisation
Secondary outcome [2] 434892 0
Back pain
Timepoint [2] 434892 0
Baseline, and at 12, 26 and 52-weeks post randomization
Secondary outcome [3] 434893 0
Leg pain
Timepoint [3] 434893 0
Baseline, and at 12, 26 and 52-weeks post randomization
Secondary outcome [4] 434894 0
Overall pain severity
Timepoint [4] 434894 0
Baseline, and at 12, 26 and 52-weeks post randomization
Secondary outcome [5] 434895 0
Pain interference
Timepoint [5] 434895 0
Baseline, and at 12, 26 and 52-weeks post randomization
Secondary outcome [6] 434896 0
Pain related disability
Timepoint [6] 434896 0
Baseline, and at 12, 26 and 52-weeks post randomisation
Secondary outcome [7] 434897 0
Depression
Timepoint [7] 434897 0
Baseline, and at 12, 26 and 52-weeks post randomization
Secondary outcome [8] 434898 0
Pain-related self efficacy
Timepoint [8] 434898 0
Baseline, and at 12, 26 and 52-weeks post randomisation
Secondary outcome [9] 434899 0
Pain-related Catastrophisation
Timepoint [9] 434899 0
Baseline, and at 12, 26 and 52-weeks post randomization
Secondary outcome [10] 434900 0
Psychosocial risk factors
Timepoint [10] 434900 0
Baseline, and at 12, 26 and 52-weeks post randomization
Secondary outcome [11] 434901 0
Post-traumatic stress
Timepoint [11] 434901 0
Baseline, and at 12, 26 and 52-weeks post randomisation
Secondary outcome [12] 434902 0
Sleep quality
Timepoint [12] 434902 0
Baseline, and at 12, 26 and 52-weeks post randomisation
Secondary outcome [13] 434903 0
Sleep beliefs
Timepoint [13] 434903 0
Baseline, and at 12, 26 and 52-weeks post randomisation
Secondary outcome [14] 434904 0
Central sensitisation
Timepoint [14] 434904 0
Baseline, and at 12, 26 and 52-weeks post randomisation
Secondary outcome [15] 434905 0
Neuropathic pain
Timepoint [15] 434905 0
Baseline, and at 12, 26 and 52-weeks post randomisation
Secondary outcome [16] 434906 0
Alcohol misuse
Timepoint [16] 434906 0
Baseline, and at 12, 26 and 52-weeks post randomisation
Secondary outcome [17] 434907 0
Drug misuse
Timepoint [17] 434907 0
Baseline, and at 12, 26 and 52-weeks post randomisation
Secondary outcome [18] 434908 0
Quality of life
Timepoint [18] 434908 0
Baseline, and at 12, 26 and 52-weeks post randomization
Secondary outcome [19] 434909 0
Global rating of change
Timepoint [19] 434909 0
12, 26 and 52-weeks post randomization
Secondary outcome [20] 434910 0
Clinical features of inflammation
Timepoint [20] 434910 0
Baseline and at 12, 26 and 52-weeks post randomization
Secondary outcome [21] 434911 0
Healthcare use (for cost-effectiveness analysis)
Timepoint [21] 434911 0
12, 26 and 52-weeks post randomization
Secondary outcome [22] 434912 0
Satisfaction with treatment
Timepoint [22] 434912 0
12, 26 and 52-weeks post randomization
Secondary outcome [23] 434913 0
Treatment Credibility
Timepoint [23] 434913 0
12, 26 and 52-weeks post randomization
Secondary outcome [24] 434914 0
Compliance with treatment (number of treatments attended)
Timepoint [24] 434914 0
12, 26 and 52-weeks post randomisation
Secondary outcome [25] 434915 0
Compliance with treatment (patient self-reported)
Timepoint [25] 434915 0
12, 26 and 52-weeks post randomisation
Secondary outcome [26] 434916 0
Motor control features
Timepoint [26] 434916 0
Baseline, and a 26 weeks post randomisation
Secondary outcome [27] 434954 0
Number of work hours missed in the last week
Timepoint [27] 434954 0
Baseline and at 12, 26 and 52 weeks post randomization
Secondary outcome [28] 436383 0
Anxiety
Timepoint [28] 436383 0
Baseline and at 12, 26 and 52 weeks post randomization
Secondary outcome [29] 436384 0
Stress
Timepoint [29] 436384 0
Baseline and at 12, 26 and 52 weeks post randomization

Eligibility
Key inclusion criteria
i. Have a primary complaint of chronic low back pain (pain of greater than 3 months duration)
ii. Referred for a multidisciplinary pain management program
iii. Aged between 18 and 60 years
iv. Sufficient fluency in English to complete all baseline and follow up questionnaires
v. Are presumed to have a pain type of nociceptive or neuropathic dominant based on established criteria
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Red flag pathologies (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. Active cancer, pelvic pain or neuropathic pain not related to low back disorders
iii. Recent or pending surgery for the pain condition;
iv. Pregnancy or childbirth within the last 6 months
v. Spinal injections for the pain problem within the last 6 weeks
vi. Already received multi-disciplinary pain management for the pain problem within the last 2 years, to avoid contamination
vii. Unable to participate in a pain management program to improve lumbar spine related activity limitation, due to significant musculoskeletal comorbidity

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, after baseline assessment, the treatment centre will email the consenting participant’s name and date of birth to an offsite randomisation service. This service will have no contact with trial participants. They will allocate the participant to a treatment group in accordance with the randomisaton schedule and advise the treatment centre of the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation schedule for allocating participants to either of the groups will be prepared in advance by an offsite researcher not involved in assessing, enrolling or treating the participants. Block randomisation (with random block lengths), with stratification for treatment centre (7 levels) will be employed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
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). 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 moderator analysis: The following factors will be evaluated for their ability to moderate the effects of treatment on the primary outcome:
1. Dominant pain type (neuropathic or nociceptive)
2. Positive response to correction of unhelpful motor control characteristics at baseline assessment

Mediation analysis: the sample is sufficient for detecting moderate or large mediation effects. The following variables will be explored for their ability to mediate the effects of treatment on the primary outcome:

1. Changes in motor control characteristics chosen as relevant by the therapist for each individual on physical examination

If pre-planned effect 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
Not yet recruiting
Date of first participant enrolment
Anticipated
24/06/2024
Actual
Date of last participant enrolment
Anticipated
30/06/2026
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
184
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316476 0
Commercial sector/Industry
Name [1] 316476 0
Advance Healthcare
Country [1] 316476 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Country
Australia
Secondary sponsor category [1] 318651 0
None
Name [1] 318651 0
Address [1] 318651 0
Country [1] 318651 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315270 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 315270 0
https://www.latrobe.edu.au/researchers/research-office/ethics/human-ethics
Ethics committee country [1] 315270 0
Australia
Date submitted for ethics approval [1] 315270 0
Approval date [1] 315270 0
01/04/2021
Ethics approval number [1] 315270 0
HEC21026

Summary
Brief summary
Given the burden of chronic pain to society and individuals and the potential to improve outcomes through adjunctive treatment, a randomised controlled trial comparing the effectiveness of multi-disciplinary pain management (PM) on its own versus multi-disciplinary pain management plus an additional treatment is planned for people with nociceptive or neuropathic dominant low back pain. We hypothesise that the additional treatment added to a pain management program will lead to some additional benefits for people with low back pain compared to a pain management program alone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134182 0
A/Prof Jon Ford
Address 134182 0
Advance Healthcare, Level 1, 157 Scoresby Rd, BORONIA VIC 3155
Country 134182 0
Australia
Phone 134182 0
+61 422 244 183
Fax 134182 0
Email 134182 0
jford@advancehealthcare.com.au
Contact person for public queries
Name 134183 0
Jon Ford
Address 134183 0
Advance Healthcare, Level 1, 157 Scoresby Rd, BORONIA VIC 3155
Country 134183 0
Australia
Phone 134183 0
+61 422 244 183
Fax 134183 0
Email 134183 0
jford@advancehealthcare.com.au
Contact person for scientific queries
Name 134184 0
Jon Ford
Address 134184 0
Advance Healthcare, Level 1, 157 Scoresby Rd, BORONIA VIC 3155
Country 134184 0
Australia
Phone 134184 0
+61 422 244 183
Fax 134184 0
Email 134184 0
jford@advancehealthcare.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data of published results only
When will data be available (start and end dates)?
On trial completion until data retention period (15 years post publication of main trial results)
Available to whom?
Researchers affiliated with a research institution
Available for what types of analyses?
Analyses based on the hypothesis to be tested on request from the researcher
How or where can data be obtained?
Via direct application to the Principal Investigator (j.ford@latrobe.edu.au) or ethics committee (humanethics@latrobe.edu.au)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22374Study protocol    To be published in a peer-reviewed journal
22375Statistical analysis plan  j.ford@latrobe.edu.au To be available prior to data analysis
22376Informed consent form  j.ford@latrobe.edu.au Available on request



Results publications and other study-related documents

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