None listed
Conditions
Brief summary
SAFE will be a pragmatic randomised controlled trial comparing, a McKenzie based self-management method where participants in the intervention group will attend 2 x 30 minute individual sessions with a trained physiotherapist and the control group will receive advice delivered over the phone and an educational booklet on how to manage back pain. 396 participants, who have recently recovered from an episode of non-specific low back pain, will be recruited through community and website advertisement and primary care clinicians (GPs, physiotherapists and chiropractors). Participants will be followed up for a minimum of 12 months. The primary outcome will be days from randomisation to first self-reported recurrence of an episode of activity limiting LBP (somewhat or greater activity limitation measured using an adaptation of item PI9 of the PROMIS item bank to measure pain interference). The secondary outcomes will be days from randomisation to first self-reported recurrence of (i) an episode of non-specific LBP (intensity equal or greater than 3/10 on the numeric pain rating scale, lasting at least 24 hours), (ii) an episode of care seeking (with consultation to a health care provider) LBP and impact of back pain measured by the Impact of Back Pain Questionnaire using 9 items of the 29-item PROMIS form.
Interventions
Participants allocated to the McKenzie based self-management approach group will attend 2 x 30 minute individual sessions with a trained physiotherapist. These sessions will be approximately 2 weeks apart. The participant will be trained in an individualised simple specific exercise program focusing on movements that balance/counteract the postures or positions used throughout the day. Since the intervention is individualised for each participant, the exercises to be completed at home will vary in frequency and duration based on the judgement of the assessing physiotherapist to suit each individual's case. The intended exercises are aimed at changing habits, therefore therapists will emphasise the importance of continuing these exercises indefinitely as a prevention strategy for back pain recurrence. For most people the exercise program will involve lumbar extension to counteract the large amount of flexion activity typical of most people’s lives either in sitting or manual tasks, following a McKenzie approach. Adherence will be monitored by 1) recording attendance to physiotherapy visits, 2) asking physiotherapists to rate their perception of participant compliance to the home exercise program between the participants initial and final visit (2 weeks period) and 3) asking participants to rate compliance with home program using the Brief Adherence Rating Scale at 3, 6, 9 and 12 month follow-ups.
Sponsors
Study design
Eligibility
Inclusion criteria
(i) Recently recovered from a previous episode of non-specific LBP (with or without leg pain) within the last 6 months. Non-specific LBP is defined as pain in the area between the 12th rib and buttock crease not attributed to a specific diagnosis such as (ankylosing spondylitis, vertebral fracture, etc). Recovery is described as occurring after 7 consecutive days with pain no greater than 1 on a 0-10 numeric pain scale; (ii) Participants at least 18 years old; (iii) currently not taking any medication for low back pain.
Exclusion criteria
* Previous spinal surgery; * Co-morbidity restricting or preventing safe participation in exercise (screened using Physical Activity Readiness Questionnaire (PARQ+); * Inadequate English to complete outcome measures; * Previously exposed to McKenzie based self-management approach as a method of preventing future low back pain; * Currently pregnant.