Home-based Exercise Rehabilitation With a Novel Digital Biofeedback System for Chronic Low Back Pain
WithdrawnNot applicableNCT04401683
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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)
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 solution on the treatment of non-specific chronic low back pain (CLBP) in adults versus standard of care. The hypothesis is that all the clinical outcomes measured will significantly improve after the program, and patients using this novel system will attain better outcomes than the ones in the standard of care group. This evidence-based digital program developed by SWORD Health is built on three main pillars - therapeutic exercise, education and cognitive-behavioural therapy, and is specifically tailored to address CLBP. The program will be delivered directly at patient's home, using a biofeedback system and continuous personalised remote clinical monitoring.
Study details
- Official title
- Home-based Exercise Rehabilitation With a Novel Digital Biofeedback System for Non-specific Chronic Low Back Pain: a Randomized Controlled Trial
- Conditions
- Interventions
- Device: Home-based rehabilitation with a digital biofeedback system
- Other: Conventional home-based rehabilitation
- Sponsor
- Sword Health, SA
- Collaborators
- Centro Hospitalar do Porto
- Start date
- 2021-05-25
- Primary completion
- 2022-07-01
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Countries
- Portugal
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Patients aged between 18 and 70 years 2. 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 3. Ability to understand motor complex commands Exclusion Criteria: 1. Pregnancy or breast-feeding 2. Inability to stand upright 3. Clear indication for surgery or other medical treatment (e.g. cancer, infection, cauda equina syndrome, significant lumbar disc herniation or rupture, nerve compression) 4. Acute low back pain in the past 7 days or unilateral or bilateral radicular pain 5. Neurologic condition (e.g. stroke, multiple sclerosis, Parkinson's disease) 6. Concomitant treatment for LBP 7. Cardiac, respiratory or other condition incompatible with at least 30 minutes of light to moderate physical activity 8. 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 9. Osteoarticular condition (e.g. fractures or severe osteoarthrosis) that prevents the patient from complying with a home-based exercise program 10. Other medical complications that prevent the patient from complying with a home-based exercise program 11. Illiteracy
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04401683