Status:
WITHDRAWN
Home-based Exercise Rehabilitation With a Novel Digital Biofeedback System for Chronic Low Back Pain
Lead Sponsor:
Sword Health, SA
Collaborating Sponsors:
Centro Hospitalar e Universitário do Porto
Conditions:
Non-specific Chronic Low Back Pain
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The present study is a a single-center, prospective, non-blind, parallel-group, randomized controlled trial, designed to evaluate the clinical impact of a home-based program using a new digital soluti...
Detailed Description
Low back pain (LBP) has for long been the world's leading cause of years leaved with disability, and, considering that the overall life expectancy is rising, this pandemic only tends to get worse. Nea...
Eligibility Criteria
Inclusion
- Patients aged between 18 and 70 years
- Intermittent or persistent low back pain for at least 3 months and on at least half the days in the previous 6 months without peripheral symptoms
- Ability to understand motor complex commands
Exclusion
- Pregnancy or breast-feeding
- Inability to stand upright
- Clear indication for surgery or other medical treatment (e.g. cancer, infection, cauda equina syndrome, significant lumbar disc herniation or rupture, nerve compression)
- Acute low back pain in the past 7 days or unilateral or bilateral radicular pain
- Neurologic condition (e.g. stroke, multiple sclerosis, Parkinson's disease)
- Concomitant treatment for LBP
- Cardiac, respiratory or other condition incompatible with at least 30 minutes of light to moderate physical activity
- Severe reduction of visual and/or auditory acuity, aphasia, dementia or psychiatric comorbidity significantly interfering with communication or compliance to a home-based exercise program
- Osteoarticular condition (e.g. fractures or severe osteoarthrosis) that prevents the patient from complying with a home-based exercise program
- Other medical complications that prevent the patient from complying with a home-based exercise program
- Illiteracy
Key Trial Info
Start Date :
May 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04401683
Start Date
May 25 2021
End Date
July 1 2022
Last Update
May 28 2021
Active Locations (1)
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1
Centro Hospitalar e Universitário do Porto - Largo Prof Abel Salazar
Porto, Portugal, 4099-001