Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000221459
Ethics application status
Approved
Date submitted
4/02/2025
Date registered
27/03/2025
Date last updated
27/03/2025
Date data sharing statement initially provided
27/03/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising exercise for chronic back pain
Scientific title
Optimising Exercise Interventions for Pain Management in People with Chronic Low Back Pain
Secondary ID [1] 313866 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic back pain 336532 0
Condition category
Condition code
Musculoskeletal 333043 333043 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 333044 333044 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised controlled trial of Education + Motivational Interviewing-Cognitive Behavioural Therapy (Edu + MI-CBT) to support an education and exercise programme compared to Usual Care (education and exercise) for people with chronic low back pain.

The Edu + MI-CBT intervention consists of five weekly 1:1 sessions with an investigator trained in MI-CBT techniques. Each session will be approximately 30 minutes duration. Throughout the intervention the principles of the MI spirit (collaboration, evocation, acceptance, and compassion) are central to all interactions, fostering a supportive and non-judgmental environment. Participants will receive the ‘Navigating Pain’ booklet (NZ Pain Society) and evidence-based exercise programmes previously validated by the research group for people with cLBP, in addition to the supporting ‘homework book’. These resources are intended for collaborative engagement during the sessions.

The exercise programme involves calisthenic (i.e., bodyweight only) exercises commonly recommended for people with chronic low back pain, which the research group have provided quantitative evidence to support in multiple trials. Exercises include the bird-dog (aka, quadruped), partial curl-up, side bridge, in addition to body weight squat and lunge variations.

The homework book is to be completed between sessions 1 and 2, and involves five sections (developed with feedback from patients) addressing beliefs about pain, beliefs about physical activity, descriptions around what a normal sleep routine looks like, thoughts around types of treatment they like to use or engage with for their symptoms, and self-directed action-planning to help manage their ongoing symptoms.

Each 30-minute session can be conducted face-to-face or via telecommunication (e.g., Zoom). The sessions cover: 1) rapport development, exploration of patient history, motivation assessment, and goal-setting; 2) examination of maladaptive pain beliefs and discussion about physical activity; 3) review of previous discussions, focus on physical activity, sleep routines; 4) review, discussion of treatment engagement and mental health factors; 5) review and development of a patient-directed action plan for sustained well-being.

The intervention is guided by MI techniques, including open-ended questions, affirmations, reflections, and summaries, to facilitate discussions on managing cLBP. CBT strategies, such as shared goal setting, problem-solving, coping strategies, and relapse planning, are delivered within this MI framework.

Self-report data will be collected at baseline, after the intervention (5-weeks) and at 3 and 12 months. Measures will include the Oswestry Disability Index, Numeric Pain Rating Scale, Pain Catastrophizing Scale, Fear-Avoidance Beliefs Questionnaire, Pain Self-Efficacy Questionnaire, and Hospital Anxiety and Depression Scale. Additionally, demographic information and participant self-reports of ongoing physical activity, treatment engagement, medication use, and employment status will be collected.

The intervention will be delivered by post-graduate qualified allied health professionals who have received specific training in the MI-CBT intervention to be delivered in this study. This entails training with experienced health psychologists in the skills of MI-CBT, which was delivered over a 6-month period in 2023, in addition to post-graduate level training including MI-CBT training. The direct familiarisation with specifics of the intervention will be provided over a 4-week period for 4-hours per week, prior to commencing recruitment for the main study. In addition, both health professionals in this study have greater than 5 years clinical experience.
Session attendance checklists will be maintained throughout the study, in addition to noting completion of the homework book (at session 2). Fidelity of the interventions will be checked by random recording of sessions to ensure both groups are receiving the intervention as designed.

This study is based at the University of Auckland, NZ, and the New Zealand College of Chiropractic (Mt Wellington, Auckland NZ).
Intervention code [1] 330454 0
Rehabilitation
Intervention code [2] 330455 0
Behaviour
Intervention code [3] 330456 0
Lifestyle
Comparator / control treatment
The Usual care intervention will control for participant interaction time with an expert clinician through five weekly 30-minute 1:1 sessions, and will provide the same core resources as the MI-CBT group. Participants will receive the ‘Navigating Pain’ booklet, the evidence-based exercise programmes for back pain, and the homework book. During sessions, clinicians will encourage participants to discuss any desired aspect related to the weekly topic, responding with interest and attention but without using any MI-CBT techniques. Clinicians will also advise participants to continue using the booklet and exercise programme without further tailoring. In session 4, clinicians will provide directive information on the lack of support for certain cLBP treatments, such as medication and massage.

Self-report data will be collected at baseline, after the intervention (5-weeks) and at 3 and 12 months. Measures will include the Oswestry Disability Index, Numeric Pain Rating Scale, Pain Catastrophizing Scale, Fear-Avoidance Beliefs Questionnaire, Pain Self-Efficacy Questionnaire, and Hospital Anxiety and Depression Scale. Additionally, demographic information and participant self-reports of ongoing physical activity, treatment engagement, medication use, and employment status will be collected.

The intervention will be delivered by post-graduate qualified allied health professionals who have received specific training in the MI-CBT intervention to be delivered in this study. Both health professionals in this study have greater than 5 years clinical experience. Session attendance checklists will be maintained throughout the study, in addition to noting completion of the homework book (at session 2). Fidelity of the interventions will be checked by random recording of sessions to ensure both groups are receiving the intervention as designed.

This study is based at the University of Auckland, NZ, and the New Zealand College of Chiropractic (Mt Wellington, Auckland NZ).
Control group
Active

Outcomes
Primary outcome [1] 340589 0
Low back related disability
Timepoint [1] 340589 0
Baseline, post-intervention (5-weeks), 3-months, 12-months (primary timepoint)
Primary outcome [2] 340590 0
Pain intensity
Timepoint [2] 340590 0
Baseline, post-intervention (5-weeks), 3-months, 12-months (primary timepoint)
Secondary outcome [1] 444528 0
Fear-avoidance
Timepoint [1] 444528 0
Baseline, post-intervention (5-weeks), 3-months, 12-months
Secondary outcome [2] 444529 0
Catastrophising
Timepoint [2] 444529 0
Baseline, post-intervention (5-weeks), 3-months, 12-months
Secondary outcome [3] 444530 0
Depression
Timepoint [3] 444530 0
Baseline, post-intervention (5-weeks), 3-months, 12-months
Secondary outcome [4] 444531 0
Anxiety
Timepoint [4] 444531 0
Baseline, post-intervention (5-weeks), 3-months, 12-months
Secondary outcome [5] 444532 0
Pain self-efficacy
Timepoint [5] 444532 0
Baseline, post-intervention (5-weeks), 3-months, 12-months
Secondary outcome [6] 444534 0
Physical activity reporting
Timepoint [6] 444534 0
Baseline, post-intervention (5-weeks), 3-months, 12-months
Secondary outcome [7] 444535 0
Treatment engagement
Timepoint [7] 444535 0
Baseline, post-intervention (5-weeks), 3-months, 12-months
Secondary outcome [8] 444536 0
Medication use
Timepoint [8] 444536 0
Baseline, post-intervention (5-weeks), 3-months, 12-months

Eligibility
Key inclusion criteria
People are eligible for inclusion if they report back pain with a pain intensity rating of at least 3 out of 10 on an 11-point numerical rating scale that persisted for at least 12 consecutive weeks. Additional inclusion criteria are age between 18 and 70 years, fluency in the English language, and ability to access the internet.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include people with back pain with or without radicular symptoms caused by a serious medical condition (i.e,, infection, fracture, herniation, malignancy), who were pregnant or gave birth in the past 6-months, who have under gone any spinal surgery or were scheduled for major surgery in the next 12-months, with an uncontrolled mental health condition that would impede participation, and with contraindications to physical activity.

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)
Central randomization by computer, researcher not involved in recruitment, assessment, or delivery of interventions in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple computer based randomization in blocks of 4 (n=130)
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
The primary outcomes of this study are low back related disability and pain for each group, over the next 12-months. Data will be analysed by a statistician who is blinded to group status. The primary analyses will be by intention-to-treat for any missing data, with a significance level of p=0.05. Mediation analysis will be used to explore how changes in participant self-report explains relationships between group (Edu + MI-CBT vs Usual Care) and 12-month outcomes for back pain intensity, disability, and healthcare seeking behaviour (i.e., number of treatments participants report, medication use).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/04/2025
Actual
Date of last participant enrolment
Anticipated
31/03/2027
Actual
Date of last data collection
Anticipated
31/03/2028
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment outside Australia
Country [1] 26859 0
New Zealand
State/province [1] 26859 0
Auckland

Funding & Sponsors
Funding source category [1] 318333 0
Charities/Societies/Foundations
Name [1] 318333 0
Lotteries Health Research Grant
Country [1] 318333 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 320728 0
Other
Name [1] 320728 0
NZ College of Chiropractic
Address [1] 320728 0
Country [1] 320728 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316969 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 316969 0
Ethics committee country [1] 316969 0
New Zealand
Date submitted for ethics approval [1] 316969 0
03/02/2025
Approval date [1] 316969 0
10/03/2025
Ethics approval number [1] 316969 0
2025 EXP 22199

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

Contacts
Principal investigator
Name 139602 0
Dr Paul Marshall
Address 139602 0
University of Auckland, Building 907 Suiter Street, Newmarket, Auckland 1023
Country 139602 0
New Zealand
Phone 139602 0
+64221006197
Fax 139602 0
Email 139602 0
[email protected]
Contact person for public queries
Name 139603 0
Paul Marshall
Address 139603 0
University of Auckland, Building 907 Suiter Street, Newmarket, Auckland 1023
Country 139603 0
New Zealand
Phone 139603 0
+64221006197
Fax 139603 0
Email 139603 0
[email protected]
Contact person for scientific queries
Name 139604 0
Paul Marshall
Address 139604 0
University of Auckland, Building 907 Suiter Street, Newmarket, Auckland 1023
Country 139604 0
New Zealand
Phone 139604 0
+64221006197
Fax 139604 0
Email 139604 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee

• -

What individual participant data might be shared?
• Deidentified self-report data with no participant demographics will be available upon reasonable request to the lead investigator.

What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
• Data will be available for any approved analyses by third party researchers.

When can requests for individual participant data be made (start and end dates)?
From:
Requirements within the ethics application for this study indicate that all data will be destroyed completely after 10-years (including digital deidentified data). This will be 10-years following ethics approval (estimated in April 2025), so data will be available on reasonable request until April 2035.

To:
30/04/2035
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

• Data can only be provided by the lead investigator via direct contact. ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


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.