Translation of Robotic Apparel for Alleviating Low Back Pain
CompletedNot applicableNCT05736393
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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').
Study details
- Official title
- Translation of Robotic Apparel for Alleviating Low Back Pain: Back Pain Consortium (BACPAC)
- Conditions
- Interventions
- Device: Back Exosuit
- Sponsor
- Boston University Charles River Campus
- Collaborators
- Harvard University; National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Start date
- 2024-03-15
- Primary completion
- 2025-05-10
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05736393