The Effect of an App-Based Home Exercise Program on Self-reported Pain Intensity in Unspecific and Degenerative Back Pain: Pragmatic Open-label Randomized Controlled Trial

BackgroundThe recommended first-line treatment for unspecific and degenerative back pain consists of movement exercises and patient education. ObjectiveUsing a pragmatic, randomized controlled trial, we evaluated the effectiveness of a digital home exercise progra...

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Main Authors: Hannes Weise, Benedikt Zenner, Bettina Schmiedchen, Leo Benning, Michael Bulitta, Daniel Schmitz, Kuno Weise
Format: Article
Language:English
Published: JMIR Publications 2022-10-01
Series:Journal of Medical Internet Research
Online Access:https://www.jmir.org/2022/10/e41899
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author Hannes Weise
Benedikt Zenner
Bettina Schmiedchen
Leo Benning
Michael Bulitta
Daniel Schmitz
Kuno Weise
author_facet Hannes Weise
Benedikt Zenner
Bettina Schmiedchen
Leo Benning
Michael Bulitta
Daniel Schmitz
Kuno Weise
author_sort Hannes Weise
collection DOAJ
description BackgroundThe recommended first-line treatment for unspecific and degenerative back pain consists of movement exercises and patient education. ObjectiveUsing a pragmatic, randomized controlled trial, we evaluated the effectiveness of a digital home exercise program on self-reported pain intensity compared with the standard of care for physiotherapy. MethodsParticipant recruitment was based on newspaper advertisements and a consecutive on-site assessment for eligibility and enrollment. Participants with unspecific and degenerative back pain aged ≥18 years were randomly assigned in a 1:1 ratio to receive a 12-week stand-alone digital home exercise program or physiotherapy. The digital home exercise program included 4 exercises daily, while physiotherapy included 6 to 12 sessions, depending on the severity of symptoms. The primary outcome was pain, which was assessed using a verbal numerical rating scale. The clinical relevance of pain reduction was assessed using the following thresholds: improvement of at least 1.4 points on the verbal numerical rating scale and a pain reduction of at least 30%. ResultsDuring the study period, 108 participants were assigned to the intervention group and 105 participants to the control group. The mean difference in pain scores between the 2 groups at 12 weeks was −2.44 (95% CI −2.92 to −1.95; P<.01) in favor of the intervention group. The group receiving the digital therapeutic achieved a clinically relevant reduction in pain over the course of the study (baseline vs 12 weeks), with a mean change of −3.35 (SD 2.05) score points or −53.1% (SD 29.5). By contrast, this change did not reach clinical relevance in the control group (mean −0.91, SD 1.5; −14.6%, SD 25.3). Retention rates of 89.9% in the intervention group and 97.3% in the control group were maintained throughout the study. ConclusionsThe use of the app-based home exercise program led to a significant and clinically relevant reduction in pain intensity throughout the 12-week duration of the program. The intervention studied showed superior improvement in self-reported pain intensity when compared with the standard of care. Given the great demand for standard physiotherapy for unspecific and degenerative back pain, digital therapeutics are evolving into a suitable therapeutic option that can overcome the limitations of access and availability of conventional modes of health care delivery into this spectrum of indications. However, further independent evaluations are required to support the growing body of evidence on the effectiveness of digital therapeutics in real-world care settings. Trial RegistrationGerman Clinical Trials Register DRKS00022781; https://tinyurl.com/hpdraa89
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spelling doaj.art-d9533d6daac246ef9b15aa204dcd5b262023-08-28T23:21:01ZengJMIR PublicationsJournal of Medical Internet Research1438-88712022-10-012410e4189910.2196/41899The Effect of an App-Based Home Exercise Program on Self-reported Pain Intensity in Unspecific and Degenerative Back Pain: Pragmatic Open-label Randomized Controlled TrialHannes Weisehttps://orcid.org/0000-0001-8443-740XBenedikt Zennerhttps://orcid.org/0000-0002-4678-9970Bettina Schmiedchenhttps://orcid.org/0000-0003-0645-3898Leo Benninghttps://orcid.org/0000-0002-8429-9702Michael Bulittahttps://orcid.org/0000-0002-1928-3886Daniel Schmitzhttps://orcid.org/0000-0001-9485-328XKuno Weisehttps://orcid.org/0000-0002-2365-2285 BackgroundThe recommended first-line treatment for unspecific and degenerative back pain consists of movement exercises and patient education. ObjectiveUsing a pragmatic, randomized controlled trial, we evaluated the effectiveness of a digital home exercise program on self-reported pain intensity compared with the standard of care for physiotherapy. MethodsParticipant recruitment was based on newspaper advertisements and a consecutive on-site assessment for eligibility and enrollment. Participants with unspecific and degenerative back pain aged ≥18 years were randomly assigned in a 1:1 ratio to receive a 12-week stand-alone digital home exercise program or physiotherapy. The digital home exercise program included 4 exercises daily, while physiotherapy included 6 to 12 sessions, depending on the severity of symptoms. The primary outcome was pain, which was assessed using a verbal numerical rating scale. The clinical relevance of pain reduction was assessed using the following thresholds: improvement of at least 1.4 points on the verbal numerical rating scale and a pain reduction of at least 30%. ResultsDuring the study period, 108 participants were assigned to the intervention group and 105 participants to the control group. The mean difference in pain scores between the 2 groups at 12 weeks was −2.44 (95% CI −2.92 to −1.95; P<.01) in favor of the intervention group. The group receiving the digital therapeutic achieved a clinically relevant reduction in pain over the course of the study (baseline vs 12 weeks), with a mean change of −3.35 (SD 2.05) score points or −53.1% (SD 29.5). By contrast, this change did not reach clinical relevance in the control group (mean −0.91, SD 1.5; −14.6%, SD 25.3). Retention rates of 89.9% in the intervention group and 97.3% in the control group were maintained throughout the study. ConclusionsThe use of the app-based home exercise program led to a significant and clinically relevant reduction in pain intensity throughout the 12-week duration of the program. The intervention studied showed superior improvement in self-reported pain intensity when compared with the standard of care. Given the great demand for standard physiotherapy for unspecific and degenerative back pain, digital therapeutics are evolving into a suitable therapeutic option that can overcome the limitations of access and availability of conventional modes of health care delivery into this spectrum of indications. However, further independent evaluations are required to support the growing body of evidence on the effectiveness of digital therapeutics in real-world care settings. Trial RegistrationGerman Clinical Trials Register DRKS00022781; https://tinyurl.com/hpdraa89https://www.jmir.org/2022/10/e41899
spellingShingle Hannes Weise
Benedikt Zenner
Bettina Schmiedchen
Leo Benning
Michael Bulitta
Daniel Schmitz
Kuno Weise
The Effect of an App-Based Home Exercise Program on Self-reported Pain Intensity in Unspecific and Degenerative Back Pain: Pragmatic Open-label Randomized Controlled Trial
Journal of Medical Internet Research
title The Effect of an App-Based Home Exercise Program on Self-reported Pain Intensity in Unspecific and Degenerative Back Pain: Pragmatic Open-label Randomized Controlled Trial
title_full The Effect of an App-Based Home Exercise Program on Self-reported Pain Intensity in Unspecific and Degenerative Back Pain: Pragmatic Open-label Randomized Controlled Trial
title_fullStr The Effect of an App-Based Home Exercise Program on Self-reported Pain Intensity in Unspecific and Degenerative Back Pain: Pragmatic Open-label Randomized Controlled Trial
title_full_unstemmed The Effect of an App-Based Home Exercise Program on Self-reported Pain Intensity in Unspecific and Degenerative Back Pain: Pragmatic Open-label Randomized Controlled Trial
title_short The Effect of an App-Based Home Exercise Program on Self-reported Pain Intensity in Unspecific and Degenerative Back Pain: Pragmatic Open-label Randomized Controlled Trial
title_sort effect of an app based home exercise program on self reported pain intensity in unspecific and degenerative back pain pragmatic open label randomized controlled trial
url https://www.jmir.org/2022/10/e41899
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