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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]

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

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

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]

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]

Activity limitation

Timepoint [1]

26 weeks post randomisation

Secondary outcome [1]

Activity limitation

Timepoint [1]

Baseline, and at 12 weeks and 52-weeks post randomisation

Secondary outcome [2]

Back pain

Timepoint [2]

Baseline, and at 12, 26 and 52-weeks post randomization

Secondary outcome [3]

Leg pain

Timepoint [3]

Baseline, and at 12, 26 and 52-weeks post randomization

Secondary outcome [4]

Overall pain severity

Timepoint [4]

Baseline, and at 12, 26 and 52-weeks post randomization

Secondary outcome [5]

Pain interference

Timepoint [5]

Baseline, and at 12, 26 and 52-weeks post randomization

Secondary outcome [6]

Pain related disability

Timepoint [6]

Baseline, and at 12, 26 and 52-weeks post randomisation

Secondary outcome [7]

Depression

Timepoint [7]

Baseline, and at 12, 26 and 52-weeks post randomization

Secondary outcome [8]

Pain-related self efficacy

Timepoint [8]

Baseline, and at 12, 26 and 52-weeks post randomisation

Secondary outcome [9]

Pain-related Catastrophisation

Timepoint [9]

Baseline, and at 12, 26 and 52-weeks post randomization

Secondary outcome [10]

Psychosocial risk factors

Timepoint [10]

Baseline, and at 12, 26 and 52-weeks post randomization

Secondary outcome [11]

Post-traumatic stress

Timepoint [11]

Baseline, and at 12, 26 and 52-weeks post randomisation

Secondary outcome [12]

Sleep quality

Timepoint [12]

Baseline, and at 12, 26 and 52-weeks post randomisation

Secondary outcome [13]

Sleep beliefs

Timepoint [13]

Baseline, and at 12, 26 and 52-weeks post randomisation

Secondary outcome [14]

Central sensitisation

Timepoint [14]

Baseline, and at 12, 26 and 52-weeks post randomisation

Secondary outcome [15]

Neuropathic pain

Timepoint [15]

Baseline, and at 12, 26 and 52-weeks post randomisation

Secondary outcome [16]

Alcohol misuse

Timepoint [16]

Baseline, and at 12, 26 and 52-weeks post randomisation

Secondary outcome [17]

Drug misuse

Timepoint [17]

Baseline, and at 12, 26 and 52-weeks post randomisation

Secondary outcome [18]

Quality of life

Timepoint [18]

Baseline, and at 12, 26 and 52-weeks post randomization

Secondary outcome [19]

Global rating of change

Timepoint [19]

12, 26 and 52-weeks post randomization

Secondary outcome [20]

Clinical features of inflammation

Timepoint [20]

Baseline and at 12, 26 and 52-weeks post randomization

Secondary outcome [21]

Healthcare use (for cost-effectiveness analysis)

Timepoint [21]

12, 26 and 52-weeks post randomization

Secondary outcome [22]

Satisfaction with treatment

Timepoint [22]

12, 26 and 52-weeks post randomization

Secondary outcome [23]

Treatment Credibility

Timepoint [23]

12, 26 and 52-weeks post randomization

Secondary outcome [24]

Compliance with treatment (number of treatments attended)

Timepoint [24]

12, 26 and 52-weeks post randomisation

Secondary outcome [25]

Compliance with treatment (patient self-reported)

Timepoint [25]

12, 26 and 52-weeks post randomisation

Secondary outcome [26]

Motor control features

Timepoint [26]

Baseline, and a 26 weeks post randomisation

Secondary outcome [27]

Number of work hours missed in the last week

Timepoint [27]

Baseline and at 12, 26 and 52 weeks post randomization

Secondary outcome [28]

Anxiety

Timepoint [28]

Baseline and at 12, 26 and 52 weeks post randomization

Secondary outcome [29]

Stress

Timepoint [29]

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?

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]

Commercial sector/Industry

Name [1]

Advance Healthcare

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

La Trobe University

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

La Trobe University Human Ethics Committee

Ethics committee address [1]

https://www.latrobe.edu.au/researchers/research-office/ethics/human-ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/04/2021

Ethics approval number [1]

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

A/Prof Jon Ford

Address

Advance Healthcare, Level 1, 157 Scoresby Rd, BORONIA VIC 3155

Country

Australia

Phone

+61 422 244 183

Fax

[email protected]

Contact person for public queries

Name

Jon Ford

Address

Advance Healthcare, Level 1, 157 Scoresby Rd, BORONIA VIC 3155

Country

Australia

Phone

+61 422 244 183

Fax

[email protected]

Contact person for scientific queries

Name

Jon Ford

Address

Advance Healthcare, Level 1, 157 Scoresby Rd, BORONIA VIC 3155

Country

Australia

Phone

+61 422 244 183

Fax

[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?

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 ([email protected]) or ethics committee ([email protected])

What supporting documents are/will be available?

Doc. No.	Type	Email	Other Details
22374	Study protocol		To be published in a peer-reviewed journal
22375	Statistical analysis plan	[email protected]	To be available prior to data analysis
22376	Informed consent form	[email protected]	Available on request

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.

Trial Review

Documents added manually

Documents added automatically