Low back pain (LBP) has a lifetime prevalence of 80%, with approximately 20% of individuals experiencing recurrent episodes or chronic LBP (cLBP). Unfortunately, the evidence for the effectiveness of most rehabilitative treatment is low. With an economic burden approaching $100-billion in the United States alone, the National Institutes of Health has invested millions of dollars in innovative technologies aiming to improve rehabilitative care for low back injuries. As part of this initiative, the investigator's collaborative network of expert clinicians, engineers, and researchers have developed and tested robotic apparel technology (exosuit) that supplements ergonomic and biomechanical training and can be utilized by clinicians in the treatment of individuals with LBP.~Failed rehabilitation, and thus progression from acute to cLBP, is thought to be caused by maladaptive motor control strategies, muscle hyperactivity, reduced movement variability, and development of fear-avoidance-beliefs. The exosuit technology was designed to reduce exertion, encourage safe, varied movement strategies, and promote recovery through well-timed assistive forces to the trunk and hips during flexion postures and lifting tasks. The proposed project builds on this work through use of the exosuit to augment traditional physical therapy care. In doing so, the investigators will determine whether this technology can enhance rehabilitation after back injuries, interrupt the progression of acute to chronic LBP, encourage non-maladaptive movement strategies, and expedite the timeline of return to prior level of function.~To examine the effects of exosuit augmented physical therapy rehabilitation and reduce disability, the investigators will recruit individuals with LBP who are referred to or receiving physical therapy into a single arm clinical trial. The investigators will evaluate changes in pain and disability throughout 6 weeks of rehabilitation and compare outcomes to a historical control group who received usual care. The investigators will also evaluate changes in fear-avoidance beliefs, range of motion, and motor control and compare outcomes between exosuit-augmented and no suit conditions over the 6 weeks. Primary outcome measures of LBP-related disability and pain--i.e., Oswestry Disability Index (ODI) and Pain Enjoyment of Life and General Activity (PEG)-- will be assessed at baseline and every visit of physical therapy care, as well as a 1-month post-discharge. Biomechanics will be assessed with exosuit mounted inertial measurement units at every 3rd visit throughout the plan of care. Other survey-based outcomes will be assessed a baseline, discharge, and 1-month post-discharge.
This is a NIAMS-sponsored pilot clinical trial being conducted through the NIH Helping to End Addition Long-term (HEAL) Initiative's Back Pain Consortium (BACPAC) Research Program. The primary objective of this pilot trial is to preliminary test the impact of a wearable soft robotic exosuit device on pain and disability when used in the physical therapy treatment of individuals with Low Back Pain (LBP). This pilot trial will also determine whether the exosuit improves training capacity within session and through the course of physical therapy care by longitudinally assessing natural and exosuit augmented biomechanics. Ultimately, these results will inform the design of a larger pragmatic clinical trial.