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Investigating the impact of education and exercise advice to prevent low back pain recurrence

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000746639
Enrollment
70
Registered
2023-07-10
Start date
2023-10-02
Completion date
2025-04-04
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to assess whether an education and exercise intervention delivered with motivational interviewing and cognitive behavioural techniques (MI-CBT) is more effective than providing advice alone for low back pain recurrence within the next year. Secondary aims are to examine between-group differences in pain-related disability, psychosocial wellbeing, care seeking behaviour, medication use, and work absence. This study is a randomized controlled trials of 166 patients with low back pain who have completed acute treatment at the New Zealand Chiropractic College. Patients will be randomly assigned to Education (Edu), or Edu + MI-CBT. Edu will involve the patient receiving ‘Navigating Pain’ (NZ Pain Society) with a supporting booklet of ‘future back pain scenarios’ provided as homework. One-week later patients will receive one further session where a home-based exercise programme is provided. Two follow-up sessions (telecommunication) will be provided two and six-weeks later. Edu + MI-CBT will will provide individualized support using the ‘homework book’ to identify unhelpful back pain beliefs and behaviours to guide patients to specific parts of ‘Navigating Pain’. MI-CBT techniques will be used at all four sessions to increase their engagement with the homework, ongoing targeted use of ‘Navigating Pain’, and a tailored exercise programme. Outcome measures will be collected at baseline, 3-, 6-, and 12-months.

Interventions

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 ad

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.

Sponsors

University of Auckland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 6, 2026