None listed
Conditions
Brief summary
TOPS will be a pragmatic comparative effectiveness randomised controlled trial with a parallel economic evaluation. It will combine three separate cohorts (TOPS Workers, TOPS Primary Care, TOPS Defence), pending funding approval, using an identical methodology. 1482 participants who have recently recovered from low back pain will be randomised to either a comprehensive exercise and education program conducted over 12 weeks, consisting of a single one-hour assessment session, 3 individual half-hour education sessions and 8 one-hour supervised group exercise sessions; or a minimal intervention consisting of the ‘Guide to Positively Managing Back Pain’ booklet and one 30 minute education and advice session. Participants will be followed up for a minimum of 1 year. The primary outcome will be days till recurrence of low back pain.
Interventions
Group exercise and education program Participants in the group exercise and education program are to receive a comprehensive, individualised exercise and education program over 12 weeks. This includes a single 1-hour clinical assessment session followed by an 8 week supervised group exercise program that is both graded and progressed. The group sessions will be conducted once per week and will run for one hour. The program will run at a ratio of between 3 - 8 participants per exercise provider. The program will also include three half-hour one-on-one sessions with the exercise provider to implement and monitor a home exercise program. These sessions will occur at four, eight and 12 weeks. The home exercise program will build upon the exercises conducted within the sessions and facilitate continuation of exercises once the supervised group exercise program has been completed. After completion of the 12-week program, weekly education and/or motivational tips will be sent to participants via phone (short message service; SMS) or email according to the participant’s preference for another 12-week period. The exercises / activities implemented as a part of this intervention will focus on four key areas of exercise training identified by the American College of Sports Medicine (ACSM). These are: 1. Cardiorespiratory exercises 2. Resistance exercises 3. Flexibility exercises 4. Neuromotor exercises All participants will be directed to meet the American College of Sports Medicine’s guidelines for cardiorespiratory exercise with specific resistance, flexibility and neuromotor components implemented according to areas of deficit identified in the initial assessment. The progression of the program will conform to the American College of Sports Medicine’s position statement. Clinical Assessment The clinical assessment session to plan the individualised exercise program will occur within one week of the baseline assessment. The purpose of the assessment session is to enable the exercise provider to determine the appropriate level (quantity and intensity) of exercises and general activity most suitable for the participant. Also, within the assessment session will be time to develop a home exercise program consistent with the ACSM principles. Group component Exercises conducted in the group sessions will focus on increasing strength, endurance and coordination of the trunk musculature. Specific exercises in the program may focus on a single area or include aspects from two or more areas above and will emphasise performance of functional everyday activities. Exercise providers will work with participants to provide an individualised and graded exercise program that reflects the participant’s physical capacity and the nature of the work, household, social and sporting activities the participant is involved in. All exercises will be conducted using the participant’s current level of fitness and ability as a starting point, and progress using the position statement on Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise as a guide. Exercise providers will use their clinical judgement to determine what aspects of exercise (cardiorespiratory, resistance, flexibility and neuromotor) to concentrate on in the group sessions. Educational component The educational component will consist of a number of elements: 1. A basic understanding of anatomy and kinesiology 2. Postural and movement education 3. Causes and management of LBP 4. Benefits of exercise 5. Motivational ideas The educational components will be delivered in two ways. The first will be conducted as part of the group classes, integrated with the provision of exercises such that while the participant is learning to perform the exercise they are also learning the theory behind what they are doing and why it is important for them. This will help in retaining the key principles of both the exercise and the education and assist in self-identification of any possible deconditioning that may occur after the exercise program has been completed. A series of ‘education tips’ have been developed to focus the education points around a different aspect at each exercise session. The second educational component will be conducted from weeks 14 through 26 with the purpose of reinforcing the education received in the classes and maintaining compliance with the exercise program beyond completion of the 12-week program. These messages will be delivered by SMS or email depending on the participants’ preference. Home exercise prescription Participants will be given four separate opportunities to develop, discuss and revise their home exercise program in individual (ie one-on-one) consultations with their exercise provider. Compliance with the program will be also checked weekly at the group sessions. The aim of the home exercise program is to progress the participants activity to a level that is consistent with the ACSM’s position statement and enable participants to continue exercising at this level beyond the duration of the group exercise program.
Sponsors
Study design
Eligibility
Inclusion criteria
Recovered from a previous episode of non-specific LBP within the last 3 months. Non-specific low back pain is defined as pain in the area of the back between the 12th rib and buttock crease not attributable to a specific diagnosis such as sciatica, or a serious spinal pathology such as ankylosing spondylitis, vertebral fracture, spinal tumour etc. The date of recovery is defined as the 7th consecutive day with pain no greater than 1 on a 0-10 pain scale.
Exclusion criteria
- Previous spinal surgery. - Any co-existing medical condition that would restrict or prevent safe participation in the exercise program using the Physical Activity Readiness Questionnaire Plus (PARQ+) as a guide. - Inadequate English to complete outcome measures. - Currently participating in an exercise program similar to the one to be evaluated in the current trial. - Unable to collect valid data for all baseline measures. - Currently pregnant - Less than 18 years of age