None listed
Conditions
Brief summary
The aim of this study is to assess the effectiveness of patient education and exercise advice facilitated by MI and CBT techniques (Edu + MI-CBT) compared to usual care provision of education and exercise only (Usual care) in reducing disability in people with cLBP. This study is a randomized controlled trials of 130 people with chronic low back pain. Participants will be randomly assigned to Usual Care or Edu + MI-CBT. Both groups will receive the same core resources (pain education book, homework booklet, exercise programme), and 5 weekly one-to-one sessions with a trained research assistant. The MI-CBT group will receive the intervention with specific use of the aforementioned behavioural techniques, whereas usual care will receive the intervention with reassurance and basic support (i.e., directive responses). Outcome measures will be collected at baseline and after the intervention, as well as at 3-, and 12-months.
Interventions
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).
Sponsors
Study design
Eligibility
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.
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.