Clinical trial NCT05736393: Translation of Robotic Apparel for Alleviating Low Back Pain
Official title: Translation of Robotic Apparel for Alleviating Low Back Pain: Back Pain Consortium (BACPAC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pain
Chronic Pain
Rehabilitation
Exosuit
Clinical Trial
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: Harvard University
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2023-02-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm clinical trials with propensity-matched control group.
Primary purpose: TREATMENT

Brief summary: This is a NIAMS-sponsored clinical trial being conducted through the NIH Helping to End Addition Long-term (HEAL) Initiative's Back Pain Consortium (BACPAC) Research Program. This is a single-arm controlled trial with individuals aged 18-70 with low back pain (LBP). This study investigates the effect(s) of augmenting physical therapy (PT) interventions with the use of an experimental wearable soft robotic device ('exosuit').

Detailed description: 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 feasibility, safety and usability of the exosuit, as well as 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 outcomes of feasibility, usability, and safety of using a back exosuit to augment routine physical therapy will be evaluated. Secondary outcomes include the efficacy of using a back exosuit to augment routine physical therapy, measured by comparing changes in self-perceived pain and disability compared to the historical control group. Tertiary outcomes include the identification of interventional phenotypes by determining the relationship between changes in symptoms and changes in biomechanics function through exosuit-augmented physical therapy.

Eligibility criteria: 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:

* Unable to attend all scheduled visits and 1-month phone follow-up
* Currently pregnant or likely to become pregnant within 6 weeks
* Having received surgery to address current LBP
* Having pain or symptoms below the knee that seems related to their current LBP
* Having current 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

Primary outcomes:
measure: Change in Suit Usability measured by Quebec User Evaluation of Satisfaction with Assistive technology (QUEST survey 2.0)
timeFrame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
measure: Change in Suit Safety measured by patient-reported pain
timeFrame: Pre and Post Every Visit including baseline (time 0), all follow-up visits (up to 8 weeks of treatment)
measure: Change in Suit Safety measured by patient reported body discomfort
timeFrame: Post Every Visit including baseline (time 0), all follow-up visits (up to 8 weeks of treatment)
measure: Change in Suit Effect & Safety measured by Perceived Task Discomfort
timeFrame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
measure: Change in Suit Effect measured by Concern of Movement
timeFrame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
measure: Change in Suit Effect measured by Perceived task effort
timeFrame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
measure: Change in Biomechanical Suit Effect measured by Trunk range of motion
timeFrame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
measure: Change in Biomechanical Suit Effect measured by Trunk velocity
timeFrame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
measure: Change in Biomechanical Suit Effect measured by trunk coordination
timeFrame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
measure: Change in Functional Suit effect measured by peak deadlift pull force
timeFrame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
measure: Change in Functional Suit Effect measured by peak dynamic lifting force
timeFrame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
measure: Change in Functional Suit Effect measured by endurance lifting task
timeFrame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
Secondary outcomes:
measure: Change in Pain measured by Numerical rating scale of pain (worst in last 24 hours)
timeFrame: Pre and Post Every Visit including baseline (time 0), all follow-up visits (up to 8 weeks of treatment), and follow-up post discharge (up to 13 weeks post time 0)
measure: Change in Patient-reported Disability score measured by the modified Oswestry Disability Questionnaire (MDQ)
timeFrame: Pre and Post Every Visit including baseline (time 0), all follow-up visits (up to 8 weeks of treatment), and follow-up post discharge (up to 13 weeks post time 0)
Other outcomes:
measure: Change in Trunk Biomechanics: peak trunk range of motion
timeFrame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
measure: Change in Trunk Biomechanics: peak trunk velocity
timeFrame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
measure: Change in Trunk Biomechanics: trunk coordination
timeFrame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
measure: Change in Physical Function: walking speed with 10 meter walk test
timeFrame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
measure: Change in Physical Function: 5x sit to stand
timeFrame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
measure: Change in Physical Function: Functional reach
timeFrame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
measure: Change in patient-reported pain symptoms: BACPAC minimum pain inventory
timeFrame: Baseline (time 0), all follow-up visits (up to 8 weeks of treatment) and post-discharge follow-up (up to 13 months from time 0)
measure: Change in Patient-reported physical function: Patient specific functional scale (PSFS)
timeFrame: Baseline (time 0), all follow-up visits (up to 8 weeks of treatment) and post-discharge follow-up (up to 13 months from time 0)
measure: Change in patient-reported pain catastrophizing: Pain catastrophizing scale (PCS-6)
timeFrame: Baseline (time 0), all follow-up visits (up to 8 weeks of treatment) and post-discharge follow-up (up to 13 months from time 0)
measure: Change in Patient-reported anxiety symptoms: Generalized anxiety disorder 2-item scale (GAD-2)
timeFrame: Baseline (time 0), all follow-up visits (up to 8 weeks of treatment) and post-discharge follow-up (up to 13 months from time 0)
measure: Change in patient reported substance use: Tobacco, Alcohol, Prescription medication and other substance use Screening tool (TAPS-1 tool)
timeFrame: Baseline (time 0), all follow-up visits (up to 8 weeks of treatment) and post-discharge follow-up (up to 13 months from time 0)
measure: Change in patient-reported pain interference: Patient-reported outcomes measurement information system - pain interference (PROMIS - pain interference)
timeFrame: Baseline (time 0), all follow-up visits (up to 8 weeks of treatment) and post-discharge follow-up (up to 13 months from time 0)
measure: Change in patient reported physical function: PROMIS - physical function
timeFrame: Baseline (time 0), all follow-up visits (up to 8 weeks of treatment) and post-discharge follow-up (up to 13 months from time 0)
measure: Change in patient-reported sleep quality: PROMIS- sleep disturbance
timeFrame: Baseline (time 0), all follow-up visits (up to 8 weeks of treatment) and post-discharge follow-up (up to 13 months from time 0)
measure: Change in patient depression scores: PROMIS - depression
timeFrame: Baseline (time 0), all follow-up visits (up to 8 weeks of treatment) and post-discharge follow-up (up to 13 months from time 0)
measure: Change in patient anxiety level: PROMIS - anxiety
timeFrame: Baseline (time 0), all follow-up visits (up to 8 weeks of treatment) and post-discharge follow-up (up to 13 months from time 0)
measure: Change in patient kinesiophobia: Optimal screening for prediction of referral and outcome cohort yellow flag assessment tool (OSPRO-YF assessment tool).
timeFrame: Baseline (time 0), all follow-up visits (up to 8 weeks of treatment) and post-discharge follow-up (up to 13 months from time 0)
measure: Change in reported pain: Pain, Enjoyment of life and General activity (PEG) Scale
timeFrame: Baseline (time 0), all follow-up visits (up to 8 weeks of treatment) and post-discharge follow-up (up to 13 months from time 0)
measure: Change in reported disability: Pain, Enjoyment of life and general activity (PEG) Scale
timeFrame: Baseline (time 0), all follow-up visits (up to 8 weeks of treatment) and post-discharge follow-up (up to 13 months from time 0)
Locations:
city: Boston
country: United States
facility: Boston University Physical Therapy Center
state: Massachusetts
Study officials:
affiliation: Harvard University
name: Conor Walsh, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston University
name: Lou N. Awad, PhD,DPT
role: PRINCIPAL_INVESTIGATOR
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