None listed
Conditions
Brief summary
It is well recognized that low back pain (LBP) is a significant public health problem. The total cost of chronic LBP in Australia is estimated at $9.17 billion yearly. Expenditures are expected to grow with the increasing obesity crisis and ageing population. Although randomised controlled trials (RCT) investigating the efficacy of conservative interventions for chronic LBP have found improvements in pain and disability associated with interventions, but patients exhibit a rapid decline in clinical outcomes after treatment discharge. These patients are likely to have recurrences of LBP and therefore seek additional care and costly, invasive procedures such as spinal surgery. Our previous research has shown that patients with chronic LBP who engage in moderate to high levels of recreational physical activity have better prognosis of pain, disability, and quality of life than those who fail to maintain adequate levels of activity. However, adherence to such lifestyle modifications is crucial and difficult to achieve. Interventions to increase physical activity based on communication technologies are becoming popular because they facilitate patients’ access and adherence to health interventions. The use of patient-centred approaches, where patients have the opportunity to share healthcare decisions, are becoming popular in LBP and have been found to be more effective than general non-specific approaches to help patients to engage in physical activity. Surprisingly, no studies have investigated the effectiveness of a physical activity intervention, particularly with the support of mobile-health (m-health) tools on long-term outcomes in patients with chronic LBP. We propose a RCT to investigate the effectiveness of an m-health patient-centered physical activity intervention for patients with chronic LBP after discharge from hospital. Patients in the experimental group will receive feedback from affordable and unobtrusive activity monitors to allow them to maintain leisure activity levels through lifestyle modification and use an m-health tool to monitor and motivate their progress. We hypothesise that the use of m-health monitoring and patient-centred lifestyle modification will reduce symptom recurrence, unnecessary spinal surgery and care seeking. We will evaluate this approach in patients receiving treatment in an outpatient physiotherapy department of Liverpool Hospital in the South-western health district of Sydney.
Interventions
The intervention group will receive an individually tailored lifestyle modification plan through the care of an experienced physiotherapist and trainned health coach over a six-month period. The intervention will involve one single face-to-face health coaching session and fortnightly telephone counseling sessions during 6 months. The face-to-face session will occuor approximately 8 days after the recruitment. The session will take place at the participant's home and should take no longer than 1
The intervention group will receive an individually tailored lifestyle modification plan through the care of an experienced physiotherapist and trainned health coach over a six-month period. The intervention will involve one single face-to-face health coaching session and fortnightly telephone counseling sessions during 6 months. The face-to-face session will occuor approximately 8 days after the recruitment. The session will take place at the participant's home and should take no longer than 1 hour. After this face-to-face session, the only contact that the Health Coach will have with the participant will be by phone, every two weeks. The phone calls should take no longer than 30 minutes. The focus of the lifestyle modification will be on a gradual patient-centred increase in physical activity where patients are encouraged to devise goals fortnightly to suit and advance their lifestyle. This intervention will be supported by the use of mobile-health which will include a specifically designed mobile WebApp and physical activity monitoring device (FitBit). The mobile WebApp will be built and customized specifically for the purposes of this project using available technology and concept currently implemented by Spare Intelligence Engine Registered Trademark. The main purpose of the application is to allow participants to record symptoms, monitor their activity and contact their health coach. Participants will be able to access the application at any time and receive feedback on their physical activity goals. Feedback messages constructed by the health coach are personalized and matched to participants’ needs by tailoring them to their response. The activity monitoring device will be provided to the participant by the health coach who will also demonstrate its use. Each participant will receive a brief orientation covering this instrument’s proper functions. Telephone support will be offered to participants who have difficulties with the device setup. The Fitbit is a physical activity tracker designed to help individuals to become more active and sleep better. This device logs a range of data about each participant’s activity, providing feedback on the number of steps taken in each 24-hour period as well as the distance walked; calories burned and sleep duration and quality. The feedback on the present day is available on the device itself and the steps taken per day, week, and month will be also summarized graphically on the device’s website (www.fitbit.com) or a Smartphone, which will also be demonstrated to the participant. The participants on the intervention group will be advised to use the Fitbit 24 hours per day continuously throughout 6 month intervention period. Adherence to the program will be assessed with the records of people who ceased involvement with the intervention prior to its completion and the reason for this, data from the Fitbit device kept by participants. Participants will also be asked to identify reasons for intervention adoption and adherence.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Male and female adults aged over 18 years, with chronic LBP persisting for over 12 weeks but without radicular symptoms; after treatment in the physiotherapy department of The Liverpool Hospital; regular (weekly) use of a computer or internet-connected tablet device; fluency in English (verbal and written)
Exclusion criteria
Any spinal surgery in the past 12 months; evidence of nerve root, spinal cord or caudal equine compression; severe spinal stenosis indicated by signs of neurogenic claudication (grade 3 to 4); fibromyalgia, or systemic/inflammatory disorder; any other current musculoskeletal injury or contraindication to increasing physical activity levels, including any cardiorespiratory or other medical condition limiting exercise tolerance; LBP caused by involvement in a road traffic accident in the last 12 months or ongoing litigation;; current pregnancy.
Outcome results
None listed