H-Wave® Device Stimulation for Chronic Low Back Pain: A Patient-Reported Outcome Measures (PROMs) Study

Abstract Introduction Chronic low back pain (cLBP) is a problem globally, creating a tremendous economic burden. Since conventional treatments often fail, various forms of electrical stimulation have been proposed to improve function and decrease pain. Patient-reported outcome measures (PROMs) have...

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Main Authors: Stephen M. Norwood, David Han, Ashim Gupta
Format: Article
Language:English
Published: Adis, Springer Healthcare 2024-01-01
Series:Pain and Therapy
Subjects:
Online Access:https://doi.org/10.1007/s40122-023-00570-6
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author Stephen M. Norwood
David Han
Ashim Gupta
author_facet Stephen M. Norwood
David Han
Ashim Gupta
author_sort Stephen M. Norwood
collection DOAJ
description Abstract Introduction Chronic low back pain (cLBP) is a problem globally, creating a tremendous economic burden. Since conventional treatments often fail, various forms of electrical stimulation have been proposed to improve function and decrease pain. Patient-reported outcome measures (PROMs) have not been adequately reported in the electrical stimulation literature. Methods A retrospective independent statistical analysis was conducted on PROMs data for users of H-Wave® device stimulation (HWDS) collected by the device manufacturer over a period of 4 years. Final surveys for 34,192 pain management patients were filtered for pain chronicity limited to 3–24 months and device use of 22–365 days, resulting in 11,503 patients with “all diagnoses”; this number was then reduced to 2711 patients with nonspecific cLBP, sprain, or strain. Results Reported pain was reduced by 3.12 points (0–10 pain scale), with significant (≥ 20%) relief in 85.28%. Function/activities of daily living (ADL) improved in 96.36%, while improved work performance was reported in 81.61%. Medication use decreased or stopped in 64.41% and sleep improved in 59.76%. Over 96% reported having expectations met or exceeded, service satisfaction, and confidence in device use, while no adverse events were reported. Subgroup analyses found positive associations with longer duration of device use, home exercise participation, and working, whereas older age and longer pain chronicity resulted in reduced benefit. Similar analysis of the larger all-diagnoses cohort demonstrated near-equivalent positive outcomes. Conclusion Treatment outcomes directly reported by cLBP HWDS patients demonstrated profound positive effects on function and ADL, robust improvement in pain perception, and additional benefits like decreased medication use, better sleep, and improved work performance, representing compelling new evidence of treatment efficacy.
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spelling doaj.art-813efc6072644063bb6f0ee0eb7103632024-01-21T12:09:30ZengAdis, Springer HealthcarePain and Therapy2193-82372193-651X2024-01-0113111312610.1007/s40122-023-00570-6H-Wave® Device Stimulation for Chronic Low Back Pain: A Patient-Reported Outcome Measures (PROMs) StudyStephen M. NorwoodDavid Han0Ashim Gupta1Department of Management Science and Statistics, University of Texas at San AntonioFuture BiologicsAbstract Introduction Chronic low back pain (cLBP) is a problem globally, creating a tremendous economic burden. Since conventional treatments often fail, various forms of electrical stimulation have been proposed to improve function and decrease pain. Patient-reported outcome measures (PROMs) have not been adequately reported in the electrical stimulation literature. Methods A retrospective independent statistical analysis was conducted on PROMs data for users of H-Wave® device stimulation (HWDS) collected by the device manufacturer over a period of 4 years. Final surveys for 34,192 pain management patients were filtered for pain chronicity limited to 3–24 months and device use of 22–365 days, resulting in 11,503 patients with “all diagnoses”; this number was then reduced to 2711 patients with nonspecific cLBP, sprain, or strain. Results Reported pain was reduced by 3.12 points (0–10 pain scale), with significant (≥ 20%) relief in 85.28%. Function/activities of daily living (ADL) improved in 96.36%, while improved work performance was reported in 81.61%. Medication use decreased or stopped in 64.41% and sleep improved in 59.76%. Over 96% reported having expectations met or exceeded, service satisfaction, and confidence in device use, while no adverse events were reported. Subgroup analyses found positive associations with longer duration of device use, home exercise participation, and working, whereas older age and longer pain chronicity resulted in reduced benefit. Similar analysis of the larger all-diagnoses cohort demonstrated near-equivalent positive outcomes. Conclusion Treatment outcomes directly reported by cLBP HWDS patients demonstrated profound positive effects on function and ADL, robust improvement in pain perception, and additional benefits like decreased medication use, better sleep, and improved work performance, representing compelling new evidence of treatment efficacy.https://doi.org/10.1007/s40122-023-00570-6Chronic painLow back painElectrical stimulationH-Wave®H-Wave device stimulationPatient-reported outcome measures
spellingShingle Stephen M. Norwood
David Han
Ashim Gupta
H-Wave® Device Stimulation for Chronic Low Back Pain: A Patient-Reported Outcome Measures (PROMs) Study
Pain and Therapy
Chronic pain
Low back pain
Electrical stimulation
H-Wave®
H-Wave device stimulation
Patient-reported outcome measures
title H-Wave® Device Stimulation for Chronic Low Back Pain: A Patient-Reported Outcome Measures (PROMs) Study
title_full H-Wave® Device Stimulation for Chronic Low Back Pain: A Patient-Reported Outcome Measures (PROMs) Study
title_fullStr H-Wave® Device Stimulation for Chronic Low Back Pain: A Patient-Reported Outcome Measures (PROMs) Study
title_full_unstemmed H-Wave® Device Stimulation for Chronic Low Back Pain: A Patient-Reported Outcome Measures (PROMs) Study
title_short H-Wave® Device Stimulation for Chronic Low Back Pain: A Patient-Reported Outcome Measures (PROMs) Study
title_sort h wave r device stimulation for chronic low back pain a patient reported outcome measures proms study
topic Chronic pain
Low back pain
Electrical stimulation
H-Wave®
H-Wave device stimulation
Patient-reported outcome measures
url https://doi.org/10.1007/s40122-023-00570-6
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