None listed
Conditions
Brief summary
The Fear Reduction Exercised Early (FREE) approach has been developed to improve the recovery of people who experience acute low back pain (LBP). This approach provides general practitioners (GPs) with a framework for managing acute LBP which is based on research into patient and GP beliefs, and international guidelines. The approach is being implemented in one geographical region in preparation for a planned national implementation. This study will compare the recovery of patients who receive care based on the FREE approach to those who receive usual LBP care. General practices will be randomly assigned to be trained in the FREE approach at the start of the study (Wave 1) or after the study (Wave 2). Patients attending practices trained in Wave 1 will receive care based on the FREE approach, while patients attending practices to be trained in Wave 2 will receive usual care. The main outcome measure for this study is the level of patient impairment six months after their first GP consultation. Other measures include patient satisfaction, quality of life, pain level, and costs associated with their back pain. The effect of the FREE approach on GP beliefs and behaviour will also be measured.
Interventions
The Fear Reduction Exercised Early (FREE) approach to low back pain (LBP). The FREE approach aims to assist GPs to identify and address attitudes and beliefs which may be barriers to recovery from LBP, explain back pain to their patients, and to provide patients with a framework which enables them to resume normal employment and activities of daily living.
General practitioner (GP) participants will be instructed in the FREE approach through an initial four-hour workshop facilitated by an exper
The Fear Reduction Exercised Early (FREE) approach to low back pain (LBP). The FREE approach aims to assist GPs to identify and address attitudes and beliefs which may be barriers to recovery from LBP, explain back pain to their patients, and to provide patients with a framework which enables them to resume normal employment and activities of daily living. General practitioner (GP) participants will be instructed in the FREE approach through an initial four-hour workshop facilitated by an experienced physiotherapist. The workshop will be supported by a booklet, a website, and a module within the practice's electronic patient management system. GPs will then practise using the approach for approximately one-month with any patients who present with low back pain before attending a one-hour refresher workshop facilitated by a physiotherapist. The refresher workshop will discuss experiences of using the approach and address any barriers identified . GPs will also be provided with a novel information booklet to provide to their patients. This booklet outlines current best practice for acute LBP, supports recommendations from the GP booklet, and addresses commonly held beliefs. It encourages an active approach to managing LBP. The booklet will also be supported by a website. Patients and GPs will have access to the website throughout the trial and on an ongoing basis following the trial. GPs will be able to continue using the FREE approach following the six to twelve-week patient recruitment period in each practice. Patients with a primary complaint of low back pain who consult GPs who have completed FREE training will receive care based on the FREE approach. Care will be provided within general practices. GPs will be able to personalise the care they provide to any individual patient based on their own clinical reasoning. All intervention group patients will receive one consultation based on the FREE approach; some patients may return to their GP for additional consultations related to their back pain and these will also be based on the FREE approach. The FREE approach will be delivered within a standard fifteen minute GP consultation. Fidelity to the approach will be assessed through i) consultation note audit; ii) patient report and; iii) analysis of audio-recordings of a random sample of 15% of all consultations, Additional care received by patients will not be controlled but it will be assessed through patient report.
Sponsors
Dr Ben Darlow
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
GP participants: New Zealand registered GP; working within the Hutt Valley region; working in a practice which has consented to participate in the study. Patient participants: LBP of any duration as their primary complaint; over 18 years of age
Exclusion criteria
GP participants: participation in pilot testing of the FREE approach. Patient participants: have had back surgery in the last six months; have been unable to do their normal work for more than three of the last six months (normal work includes unpaid work or normal daily activities for those who are retired or work at home); are unable to read and write in English; LBP is due to a potentially serious condition (e.g. cauda equina syndrome, inflammatory arthritis, malignancy, infection, aortic stenosis or aneurysm); LBP is referred from another body region or visceral organ; have a significant concomitant health condition affecting participation (e.g. pregnancy, major psychological disturbance if the patient’s GP considers it unwise for the person to participate).
Outcome results
None listed