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.

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.

Participants will receive 12 sessions of physical therapy care. This care will incorporate evidence-based physical therapy care based on clinical presentation to include manual therapy, therapeutic exercise, and functional therapeutic activities. Between 20-40 minutes of each session will include exosuit use.

The device is worn like a backpack. It weighs 6 pounds. Participants will be able to perform movements naturally in the device. A ribbon serves as an external muscle to reduce the load and effort during lifting. As participants bend forward, the device assists the participant by supporting some of their body weight by gently pulling back. As participants stand up, the device assists them by gently pulling their trunk upright. Participants will feel the level of assistance change slightly as they move faster or slower. Participants will use this device during 20-40 minutes of physical therapy exercises during 12 visits over 4-6 weeks. Once it is fit and adjusted to each participant's comfort, the physical therapist will control the level of assistance the device provides similarly to how they would adapt any given exercise. Participants may start with more assistance and wean down over the course of the study.

Patient-reported pain intensity and interference is measured by the Pain, Enjoyment of Life, and General Activity (PEG) scale. The PEG is a series of 3 questions. Results range from 0 to 10, with higher scores indicating increased pain intensity.

Patient-reported pain intensity and interference is measured by the Modified Oswestry Disability Questionnaire (MDQ) scale. The MDQ is a series of 10 questions. Results range from 0 to 5, with higher scores indicating increased low-back related disability.

Inertial measurement unit acquired biomechanics of trunk range of motion (degrees) during motion in cardinal planes and overhead squatting. Acquired during slack suit (no exosuit assistance) and active suit (exosuit assistance) conditions at each time point.

Inertial measurement unit acquired biomechanics of trunk velocity of motion (degrees per second) during motion in cardinal planes and overhead squatting. Acquired during slack suit (no exosuit assistance) and active suit (exosuit assistance) conditions at each time point.

Inertial measurement unit acquired biomechanics of trunk coordination during during motion in cardinal planes and overhead squatting. Coordination is characterized by the describing the roundness of the phase portrait between range of motion and velocity. Acquired during slack suit (no exosuit assistance) and active suit (exosuit assistance) conditions at each time point.

Measured during maximum voluntary isometric contractions (kg) using stationary dynamometer. Acquired during slack suit (no exosuit assistance) and active suit (exosuit assistance) conditions at each time point.

Endurance characterized during isometric standing forward lean with arms crossed (seconds) and legs and back straight. Acquired during slack suit (no exosuit assistance) and active suit (exosuit assistance) conditions at each time point.

Time (seconds) taken to transfer from sit to stand five times with arms crossed. Acquired during slack suit (no exosuit assistance) and active suit (exosuit assistance) conditions at each time point.

The Pain Interference (PROMIS-6) is a 6-item instrument measures the self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Pain Interference also incorporates items probing sleep and enjoyment in life. The PROMIS-6 utilizes 7-day recall period. Each item on the measure is rated on a 5-point scale ( 1=not at all; 2=a little bit; 3=somewhat; 4=quite a bit; and 5=very much) with a range in score from 6 to 30 with higher scores indicating greater severity of pain interference.

The PROMIS Sleep Disturbance is an 8-item instrument assess the domain of sleep disturbance. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.

The PSFS is a 3 to 5 item scale in which patients identify 3-5 activities they experience limitations with. They are then asked to rate their ability to complete these activities on an 11-point scale at a level experienced prior to injury or change in functional status. Higher values indicate lesser ability to perform these tasks at their prior level.

The PCS-6 is a 6-item scale used to help quantify an individual's pain experience, asking about how they feel and what they think about when they are in pain. People are asked to indicate the degree to which they have the thoughts and feelings surrounding pain experiences using a 0 (not at all) to 4 (all the time) scale with a range in score from 0 to 24 and higher scores indicating greater severity of pain catastrophizing.

The PHQ-9 is a 9-item scale used to assist healthcare providers in making the diagnosis of depression and to quantify depression symptoms and monitor severity. People are asked to indicate at what frequency they are bothered by each item on a 0 (not at all) to 3 (nearly every day) scale with a range from 0 to 27 and higher scores indicating more symptoms of depression.

The GAD-2 is a very brief and easy to perform initial screening tool for generalized anxiety disorder. People are asked to indicate at what frequency they are bothered by each item on a 0 (not at all) to 3 (nearly every day) scale with a range of 0 to 6 and higher scores indicating more anxiety.

The FABQ is a 16-item survey used for identifying how a patient's fear-avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability. Patients are asked to rank their level of agreement with each item on a 0 (completely disagree) to 6 (completely agree) scale with a range of 0 to 96 and higher scores indicating more fear avoidance beliefs.

The FDAQ is a 10-12 item survey in which patients rate their level of fear of enduring specific activities that may cause low back pain. Patients rate activities such as prolonged standing, walking, or sitting on a 0 (no fear of activity) to 100 (maximal fear of activity) scale. Each item is scored individually with higher scores indicating higher fear of each activity.

The PHODA is a 4-item scale used to identify level of concern with common activities of daily living. People are asked to indicate the level of concern or fear with a series of tasks depicted in standard photos-e.g., people doing chores such as folding laundry, vacuuming, etc. Patients rate each activity on a 0 (no concern) to 10 (extreme concern) scale. The final score ranges from 0 to 40 with higher score indicating more concern with movement.

Patient-Reported Outcome - Tobacco, Alcohol, Prescription medication, and other Substance (TAPS 1) Tool

The TAPS-1 is a 4-item screening tool used identify unhealthy substance use in patients. People are asked to indicate at what frequency they use tobacco, alcohol, prescription medication, and other substances as daily, weekly, monthly, less than monthly, or never.

The Patient Global Impression of Change (PGIC) is a single-item scale that reflects a patient's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Higher score indicated higher degree of improvement.

Inclusion Criteria: Age 18-70 Diagnosis 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 lifting Able 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-up Must not be pregnant or likely to become pregnant within 6 weeks Must not have had surgery to address current LBP Must not have radicular symptoms or pain below the buttock Must not have had LBP lasting less than 2 weeks Diagnosed or self-reported neurological disorders effecting motor control (stroke, Parkinson's disease, etc.) Use of a pacemaker or other implanted medical devices Currently under treatment for cancer Skin 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

The data will be made available upon publication of the study. It will remain available thereafter on https://healdata.org.

Members of BACPAC can access study data in the HEAL Initiative Data Repository using permalink: https://healdata.org/portal/discovery/HDP00349/

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