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ORIGINAL RESEARCH article

Front. Bioeng. Biotechnol.
Sec. Biomechanics
Volume 12 - 2024 | doi: 10.3389/fbioe.2024.1520610
This article is part of the Research Topic Biomechanics, Sensing and Bio-inspired Control in Rehabilitation and Assistive Robotics, Volume II View all articles

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

Provisionally accepted
Xiaonan Huang Xiaonan Huang 1,2Lele Huang Lele Huang 1,2Lei Shi Lei Shi 2*Lifan Xu Lifan Xu 2,3*Chengbing Cao Chengbing Cao 2*Heng Wu Heng Wu 2*Min Cao Min Cao 2*Can Lv Can Lv 2*Ping Shi Ping Shi 1*Guohui Zhang Guohui Zhang 4*Fanfu Fang Fanfu Fang 2*
  • 1 University of Shanghai for Science and Technology, Shanghai, Shanghai Municipality, China
  • 2 Changhai Hospital, Second Military Medical University, Shanghai, Beijing Municipality, China
  • 3 Shanghai University of Sport, Shanghai, Shanghai Municipality, China
  • 4 Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China

The final, formatted version of the article will be published soon.

    Background: Lumbar 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.Objective: This 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. Methods: A 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.Results: A 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).The 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.

    Keywords: Lumbar disc herniation, lumbar spine exoskeleton, Lumbar traction, range of motion, conservative treatment

    Received: 31 Oct 2024; Accepted: 23 Dec 2024.

    Copyright: © 2024 Huang, Huang, Shi, Xu, Cao, Wu, Cao, Lv, Shi, Zhang and Fang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    Lei Shi, Changhai Hospital, Second Military Medical University, Shanghai, 200433, Beijing Municipality, China
    Lifan Xu, Shanghai University of Sport, Shanghai, 200072, Shanghai Municipality, China
    Chengbing Cao, Changhai Hospital, Second Military Medical University, Shanghai, 200433, Beijing Municipality, China
    Heng Wu, Changhai Hospital, Second Military Medical University, Shanghai, 200433, Beijing Municipality, China
    Min Cao, Changhai Hospital, Second Military Medical University, Shanghai, 200433, Beijing Municipality, China
    Can Lv, Changhai Hospital, Second Military Medical University, Shanghai, 200433, Beijing Municipality, China
    Ping Shi, University of Shanghai for Science and Technology, Shanghai, 130012, Shanghai Municipality, China
    Guohui Zhang, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China
    Fanfu Fang, Changhai Hospital, Second Military Medical University, Shanghai, 200433, Beijing Municipality, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.