Evaluation of the efficacy of a novel lumbar exoskeleton with multiple interventions for patients with lumbar disc herniation: a multicenter randomized controlled trial of non-inferiority
BackgroundLumbar disc herniation (LDH) occurs when the nucleus pulposus or annulus fibrosus protrudes into the intervertebral space, potentially compressing nerve roots and causing symptoms such as sciatica, restricted mobility, and lower extremity weakness. The development of portable lumbar exoske...
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Frontiers Media S.A.
2025-01-01
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| Series: | Frontiers in Bioengineering and Biotechnology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fbioe.2024.1520610/full |
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| author | Xiaonan Huang Xiaonan Huang Lele Huang Lele Huang Lei Shi Lifan Xu Lifan Xu Chengbing Cao Heng Wu Min Cao Can Lv Ping Shi Guohui Zhang Fanfu Fang |
| author_facet | Xiaonan Huang Xiaonan Huang Lele Huang Lele Huang Lei Shi Lifan Xu Lifan Xu Chengbing Cao Heng Wu Min Cao Can Lv Ping Shi Guohui Zhang Fanfu Fang |
| author_sort | Xiaonan Huang |
| collection | DOAJ |
| description | BackgroundLumbar disc herniation (LDH) occurs when the nucleus pulposus or annulus fibrosus protrudes into the intervertebral space, potentially compressing nerve roots and causing symptoms such as sciatica, restricted mobility, and lower extremity weakness. The development of portable lumbar exoskeleton devices offers a new approach, combining traction, range of motion (ROM) exercises, and resistance training in a single system, potentially reducing treatment complexity and enhancing LDH patient outcomes.ObjectiveThis study aims to evaluate the efficacy and safety of a novel lumbar exoskeleton device compared to traditional traction methods combined with rehabilitation therapy for patients with LDH.MethodsA multicenter, non-inferiority randomized controlled trial was conducted with 118 participants diagnosed with LDH. Participants were randomly assigned to the Exoskeleton Group or the Traction Group. The Exoskeleton Group used the novel device for traction, ROM, and resistance training, while the Traction Group underwent traditional traction and rehabilitation therapy. Outcomes included efficacy rate after 10 treatments, Visual Analogue Scale (VAS), Oswestry Disability Index (ODI), and lumbar ROM—were assessed at 3, 6, and 10 treatments.ResultsA total of 118 eligible participants were recruited. After 10 treatments, both groups showed significant improvements in VAS scores, ODI, and lumbar ROM compared to baseline (P < 0.001). However, there was no significant difference in the overall efficacy rate between the two groups (P = 0.748).ConclusionThe novel lumbar exoskeleton device demonstrates comparable efficacy and safety to traditional traction therapy combined with rehabilitation, offering a promising alternative for the conservative treatment of LDH. |
| format | Article |
| id | doaj-art-bed9fd293ac644b894ef417d534cbef1 |
| institution | Kabale University |
| issn | 2296-4185 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Bioengineering and Biotechnology |
| spelling | doaj-art-bed9fd293ac644b894ef417d534cbef12025-01-27T06:40:28ZengFrontiers Media S.A.Frontiers in Bioengineering and Biotechnology2296-41852025-01-011210.3389/fbioe.2024.15206101520610Evaluation of the efficacy of a novel lumbar exoskeleton with multiple interventions for patients with lumbar disc herniation: a multicenter randomized controlled trial of non-inferiorityXiaonan Huang0Xiaonan Huang1Lele Huang2Lele Huang3Lei Shi4Lifan Xu5Lifan Xu6Chengbing Cao7Heng Wu8Min Cao9Can Lv10Ping Shi11Guohui Zhang12Fanfu Fang13School of Health Sciences and Engineering, University of Shanghai for Science and Technology, Shanghai, ChinaDepartment of Rehabilitation Medicine, Changhai Hospital, Naval Medical University, Shanghai, ChinaSchool of Health Sciences and Engineering, University of Shanghai for Science and Technology, Shanghai, ChinaDepartment of Rehabilitation Medicine, Changhai Hospital, Naval Medical University, Shanghai, ChinaDepartment of Rehabilitation Medicine, Changhai Hospital, Naval Medical University, Shanghai, ChinaDepartment of Rehabilitation Medicine, Changhai Hospital, Naval Medical University, Shanghai, ChinaSchool of Sports and Health, Shanghai University of Sport, Shanghai, ChinaDepartment of Rehabilitation Medicine, Changhai Hospital, Naval Medical University, Shanghai, ChinaDepartment of Rehabilitation Medicine, Changhai Hospital, Naval Medical University, Shanghai, ChinaDepartment of Rehabilitation Medicine, Changhai Hospital, Naval Medical University, Shanghai, ChinaDepartment of Rehabilitation Medicine, Changhai Hospital, Naval Medical University, Shanghai, ChinaSchool of Health Sciences and Engineering, University of Shanghai for Science and Technology, Shanghai, ChinaYueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, ChinaDepartment of Rehabilitation Medicine, Changhai Hospital, Naval Medical University, Shanghai, ChinaBackgroundLumbar disc herniation (LDH) occurs when the nucleus pulposus or annulus fibrosus protrudes into the intervertebral space, potentially compressing nerve roots and causing symptoms such as sciatica, restricted mobility, and lower extremity weakness. The development of portable lumbar exoskeleton devices offers a new approach, combining traction, range of motion (ROM) exercises, and resistance training in a single system, potentially reducing treatment complexity and enhancing LDH patient outcomes.ObjectiveThis study aims to evaluate the efficacy and safety of a novel lumbar exoskeleton device compared to traditional traction methods combined with rehabilitation therapy for patients with LDH.MethodsA multicenter, non-inferiority randomized controlled trial was conducted with 118 participants diagnosed with LDH. Participants were randomly assigned to the Exoskeleton Group or the Traction Group. The Exoskeleton Group used the novel device for traction, ROM, and resistance training, while the Traction Group underwent traditional traction and rehabilitation therapy. Outcomes included efficacy rate after 10 treatments, Visual Analogue Scale (VAS), Oswestry Disability Index (ODI), and lumbar ROM—were assessed at 3, 6, and 10 treatments.ResultsA total of 118 eligible participants were recruited. After 10 treatments, both groups showed significant improvements in VAS scores, ODI, and lumbar ROM compared to baseline (P < 0.001). However, there was no significant difference in the overall efficacy rate between the two groups (P = 0.748).ConclusionThe novel lumbar exoskeleton device demonstrates comparable efficacy and safety to traditional traction therapy combined with rehabilitation, offering a promising alternative for the conservative treatment of LDH.https://www.frontiersin.org/articles/10.3389/fbioe.2024.1520610/fulllumbar disc herniationlumbar spine exoskeletonlumbar tractionrange of motionconservative treatment |
| spellingShingle | Xiaonan Huang Xiaonan Huang Lele Huang Lele Huang Lei Shi Lifan Xu Lifan Xu Chengbing Cao Heng Wu Min Cao Can Lv Ping Shi Guohui Zhang Fanfu Fang Evaluation of the efficacy of a novel lumbar exoskeleton with multiple interventions for patients with lumbar disc herniation: a multicenter randomized controlled trial of non-inferiority Frontiers in Bioengineering and Biotechnology lumbar disc herniation lumbar spine exoskeleton lumbar traction range of motion conservative treatment |
| title | Evaluation of the efficacy of a novel lumbar exoskeleton with multiple interventions for patients with lumbar disc herniation: a multicenter randomized controlled trial of non-inferiority |
| title_full | Evaluation of the efficacy of a novel lumbar exoskeleton with multiple interventions for patients with lumbar disc herniation: a multicenter randomized controlled trial of non-inferiority |
| title_fullStr | Evaluation of the efficacy of a novel lumbar exoskeleton with multiple interventions for patients with lumbar disc herniation: a multicenter randomized controlled trial of non-inferiority |
| title_full_unstemmed | Evaluation of the efficacy of a novel lumbar exoskeleton with multiple interventions for patients with lumbar disc herniation: a multicenter randomized controlled trial of non-inferiority |
| title_short | Evaluation of the efficacy of a novel lumbar exoskeleton with multiple interventions for patients with lumbar disc herniation: a multicenter randomized controlled trial of non-inferiority |
| title_sort | evaluation of the efficacy of a novel lumbar exoskeleton with multiple interventions for patients with lumbar disc herniation a multicenter randomized controlled trial of non inferiority |
| topic | lumbar disc herniation lumbar spine exoskeleton lumbar traction range of motion conservative treatment |
| url | https://www.frontiersin.org/articles/10.3389/fbioe.2024.1520610/full |
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