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Trial registered on ANZCTR


Registration number
ACTRN12623000746639
Ethics application status
Approved
Date submitted
26/06/2023
Date registered
10/07/2023
Date last updated
8/09/2024
Date data sharing statement initially provided
10/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the impact of education and exercise advice to prevent low back pain recurrence
Scientific title
Investigating the use of motivational interviewing and cognitive behavioural therapy to improve the engagement of patients with low back pain to education and exercise advice to reduce recurrence
Secondary ID [1] 309976 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Back Pain 330466 0
Condition category
Condition code
Physical Medicine / Rehabilitation 327316 327316 0 0
Other physical medicine / rehabilitation
Musculoskeletal 327317 327317 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in both groups will have four 1:1 sessions with a research clinician (30 mins per session, sessions spread over an 8-week period, two sessions face-to-face, two sessions via telecommunication or face-to-face). The primary intervention group (Education + Motivational Interviewing/Cognitive Behavioural Therapy: Edu + MI-CBT) is designed to provide targeted support of the most relevant sections from the ‘Navigating Pain’ booklet (NZ Pain Society) combined with further individualised advice based on the expertise and experience of the research team. ‘Navigating Pain’ is a freely available resource designed to help people understand and manage their pain. Content sections cover Understanding Pain, Understanding Their Personal Situation, Healthy Lifestyle Choices (physical activity and sleep), and Living Your Life (i.e., identifying support, use of pacing). Participants will be also be required to complete a series of self-report outcome measures (Pain Catastrophizing Scale, Fear-Avoidance Beliefs, Pain Self-Efficacy, Hospital Depression and Anxiety Score, Oswestry Disability Index), and an interview on their recent history of lifestyle (i.e., sleep, smoking, alcohol), physical activity, and treatment choices.

A ‘homework book’ will be provided to participants in the first session with five different case-examples and encouraged self-reflection questions, based on sections of ‘Navigating Pain’. The 'homework book' will be encouraged to be completed over the week, and is estimated to take between 5 to 30 mins to complete (depending on patient engagement with material). The ‘homework’ combined with patient interview and self-report measures aims to identify the most important parts of the ‘Navigating Pain’ booklet for each individual, in addition to other factors (e.g., high levels of catastrophic pain-related thoughts, current treatment seeking behaviour) that need individual support. MI-CBT techniques will be used in the first session to encourage completion of the homework book in the subsequent week (e.g., open ended questions to probe participant solutions to common barriers as to why the homework book may not be completed - shared goal setting to affirm why participant has enrolled in this study - initial action plan development led by participant).

One week later participants will have another face-to-face session where the homework book will be used to facilitate an individualised MI-CBT guided discussion of engaging with the most important parts of ‘Navigating Pain’ for that individual, in addition to the use of any specific individual support based on the overall assessment. Physical activity advice using MI-CBT techniques will be provided to the participant based on their previous interview, taking into account their exercise preferences. Exercise advice will be supplemented by provision of a standardized trunk exercise programme used by the research team in previous clinical trials (with some recommendations embedded for performing the program up to 3 times per week, 30 mins per session). It must be noted the MI-CBT physical activity advice is to be completely individualized and has no set structure apart from attempting to meet minimum WHO physical activity standards (i.e., minimum of 500 MET.mins per week of a variety of activities).

Telecommunication based follow-up sessions will take place two and six-weeks later, where MI-CBT based interactions will be used to provide ongoing directed support of ‘Navigating Pain’, other key factors identified at baseline (or raised by the participant), in addition to the physical activity programme.

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).

The study is based at the New Zealand Chiropractic College.
Intervention code [1] 326389 0
Prevention
Intervention code [2] 326455 0
Treatment: Other
Comparator / control treatment
Participants in both groups will have four 1:1 sessions with a research clinician (30 mins per session, sessions spread over an 8-week period, two sessions face-to-face, two sessions via telecommunication or face-to-face). We designed the Control Group (Education only: Edu) to match the time of participant interaction with an expert clinician (i.e., same number of sessions as the intervention group, same time of session). The same self-report measures and interview will be used, but will not inform any individualised advice.

‘Navigating Pain’ and the homework book (as described for the intervention group - est completion 5 to 30 mins) will be provided without any MI-CBT support to facilitate engagement with the material. A standard home-based exercise programme for back pain used in other studies by the research team will be provided at the second session (trunk based exercise, 30 mins per session, 3 times per week), with no individualisation. At all sessions for the Edu group, participants will be encouraged to talk about any desired topic, with the clinicians informed to listen, show interest, and pay attention, without providing any specific MI-CBT based support or pain and lifestyle education advice. Clinicians will advise patients to keep using the ‘Navigating Pain’ booklet (without any tailoring or additional advice) and standard exercise programme.

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).

The study is based at the New Zealand Chiropractic College.
Control group
Active

Outcomes
Primary outcome [1] 335180 0
Back Pain (Numeric Pain Rating Scale).
Timepoint [1] 335180 0
Baseline (first session in study), 3-, 6-, and 12-months post intervention commencement (primary endpoint).
Secondary outcome [1] 423407 0
Pain Catastrophizing Scale
Timepoint [1] 423407 0
Baseline (first session in study), 3-, 6-, and 12-months post intervention commencement.
Secondary outcome [2] 423408 0
Fear-avoidance beliefs questionnaire
Timepoint [2] 423408 0
Baseline (first session in study), 3-, 6-, and 12-months post intervention commencement.
Secondary outcome [3] 423711 0
Hospital Anxiety and Depression Scale
Timepoint [3] 423711 0
Baseline (first session in study), 3-, 6-, and 12-months post intervention commencement.
Secondary outcome [4] 423712 0
Chronic pain self-efficacy scale
Timepoint [4] 423712 0
Baseline (first session in study), 3-, 6-, and 12-months post intervention commencement.
Secondary outcome [5] 423713 0
Oswestry Disability Index
Timepoint [5] 423713 0
Baseline (first session in study), 3-, 6-, and 12-months post intervention commencement.
Secondary outcome [6] 423714 0
Physical activity reporting (subjective reporting of participant for current levels of physical activity)
Timepoint [6] 423714 0
Baseline (first session in study), 3-, 6-, and 12-months post intervention commencement.
Secondary outcome [7] 423715 0
Treatment engagement (participant self-reporting of treatment engaged with for any back pain they have experienced in the last month)
Timepoint [7] 423715 0
Baseline (first session in study), 3-, 6-, and 12-months post intervention commencement.
Secondary outcome [8] 423716 0
Medication Use (participant self-reporting for any medication used to treat any back pain they have experienced in the last month)
Timepoint [8] 423716 0
Baseline (first session in study), 3-, 6-, and 12-months post intervention commencement.

Eligibility
Key inclusion criteria
Participants will be included if they meet the following criterion: recovered from a recent episode of non-specific low back pain, where recovery is defined as the 7th consecutive day with pain less than 3 on a 0-10 numeric pain rating scale. Non-specific low back pain is defined as pain in the area between the 12th rib and buttock crease not attributed to a specific diagnosis such as vertebral fracture or nerve root involvement.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they meet any of the following criteria: previous spinal surgery, co-morbidity e.g., unstable angina) preventing participation in exercise, and inadequate English language skills to complete outcome measures or engage in the intervention.

Study design
Purpose of the study
Prevention
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 (equal assignment to each group within each block), with final two participants assigned to either group (n=166 total, n=83 each group)
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 back pain recurrence for each group, defined as the number of participants who report back pain greater than or equal to 3 out of 10 (numeric pain rating scale) over the next 12-months, and pain intensity at 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 Edu) 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
Recruiting
Date of first participant enrolment
Anticipated
2/10/2023
Actual
2/10/2023
Date of last participant enrolment
Anticipated
4/04/2025
Actual
Date of last data collection
Anticipated
30/04/2026
Actual
Sample size
Target
166
Accrual to date
70
Final
Recruitment outside Australia
Country [1] 25610 0
New Zealand
State/province [1] 25610 0
Auckland

Funding & Sponsors
Funding source category [1] 314150 0
Charities/Societies/Foundations
Name [1] 314150 0
Lotteries Health Research Grant, NZ
Country [1] 314150 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Department of Exercise Sciences
Building 907
At the end of Suiter Street, off Khyber Pass Road
Newmarket, 1023
Auckland
Country
New Zealand
Secondary sponsor category [1] 316069 0
Other
Name [1] 316069 0
New Zealand College of Chirpractic
Address [1] 316069 0
6 Harrison Road, Mount Wellington, Auckland 1060
Country [1] 316069 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313285 0
HDEC: Southern Health and Disability Ethics Committee
Ethics committee address [1] 313285 0
Ethics committee country [1] 313285 0
New Zealand
Date submitted for ethics approval [1] 313285 0
06/06/2023
Approval date [1] 313285 0
18/08/2023
Ethics approval number [1] 313285 0

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

Contacts
Principal investigator
Name 127602 0
Dr Paul Marshall
Address 127602 0
Department of Exercise Sciences, University of Auckland, Building 907 Suiter St, Newmarket, 1023, Auckland, NEW ZEALAND
Country 127602 0
New Zealand
Phone 127602 0
+64 221006197
Fax 127602 0
Email 127602 0
p.marshall@auckland.ac.nz
Contact person for public queries
Name 127603 0
Paul Marshall
Address 127603 0
Department of Exercise Sciences, University of Auckland, Building 907 Suiter St, Newmarket, 1023, Auckland, NEW ZEALAND
Country 127603 0
New Zealand
Phone 127603 0
+64 221006197
Fax 127603 0
Email 127603 0
p.marshall@auckland.ac.nz
Contact person for scientific queries
Name 127604 0
Paul Marshall
Address 127604 0
Department of Exercise Sciences, University of Auckland, Building 907 Suiter St, Newmarket, 1023, Auckland, NEW ZEALAND
Country 127604 0
New Zealand
Phone 127604 0
+64 221006197
Fax 127604 0
Email 127604 0
p.marshall@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified self-report data with no participant demographics will be available upon reasonable request to the lead investigator.
When will data be available (start and end dates)?
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 July 2023), so data will be available on reasonable request until July 2033.
Available to whom?
Only researchers who make a sound methodological case for requesting the data will be considered on a case-by-case basis.
Available for what types of analyses?
Data will be available for any approved analyses by third party researchers.
How or where can data be obtained?
Data can only be provided by the lead investigator via direct contact. (p.marshall@auckland.ac.nz)


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.