ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Back Pain

Condition category

Condition code

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Musculoskeletal

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]

Prevention

Intervention code [2]

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]

Back Pain (Numeric Pain Rating Scale).

Timepoint [1]

Baseline (first session in study), 3-, 6-, and 12-months post intervention commencement (primary endpoint).

Secondary outcome [1]

Pain Catastrophizing Scale

Timepoint [1]