Translation of Robotic Apparel for Alleviating Low Back Pain

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.

Inclusion Criteria:Age 18-70Diagnosis of LBP by licensed medical provider or self-report of lower back pain (initially gathered through partial HIPAA waiver, and confirmed during in-person screening visit)Self-reported LBP with bending or liftingAble to walk without an assistive device.Willing and able to provide informed consent.Provide HIPAA Authorization to allow communication with the primary healthcare provider (e.g., treating physical therapist) for communication (as needed) during the study period.Must undergo physical therapy examination with research physical therapist and be assigned a Treatment-Based Classification (TBC) of movement impairment or control impairment.Exclusion Criteria:Must be able to attend all scheduled visits and 1-month phone follow-upMust not be pregnant or likely to become pregnant within 6 weeksMust not have had surgery to address current LBPMust not have radicular symptoms or pain below the buttockMust not have had LBP lasting less than 2 weeksDiagnosed or self-reported neurological disorders effecting motor control (stroke, Parkinson's disease, etc.)Use of a pacemaker or other implanted medical devicesCurrently under treatment for cancerSkin issues / sensitivity that an exosuit could exacerbate (e.g., Epidermolysis Bullosa)Any other medical conditions that would preclude safe use of the exosuit device as determined by a physical therapist