Observation of curative effect on meridian theory-based extracorporeal shock wave therapy for non-specific low back pain: study protocol for a randomized controlled trial

Fan et al. Journal of Orthopaedic Surgery and Research https://doi.org/10.1186/s13018-022-03146-w (2022) 17:265 Open Access STUDY PROTOCOL Observation of curative effect on meridian theory‑based extracorporeal shock wave therapy for non‑specific low back pain: study protocol for a randomized controlled trial Yongfu Fan1†, Feilai Liu2†, Mengna Li3†, Xiaodi Ruan1, Mingli Wu2, Kaiqi Su2, Jing Gao2 and Xiaodong Feng1,2* Abstract Background: Non-specific low back pain (NLBP) is a major global socioeconomic burden, and the prevalence of NLBP is still on the rise. At present, there is no ideal drug to cure this disease. This may be the reason why patients often use complementary therapies. Among them, extracorporeal shock wave therapy (ESWT) has gradually received more attention and has become the main treatment method for NLBP. The purpose of this study is to provide scientific evidence for the effect and safety of meridian theory-based ESWT on NLBP. Objective: This study aims to evaluate the effect and safety of meridian theory-based ESWT on NLBP. This study will also provide more high-quality experimental evidence for the clinical application of meridian theory-based ESWT for the treatment of NLBP in future. Methods: The study design is a single-blind, multi-center, randomized controlled trial. 66 patients with NLBP, aged 18 to 60 years, will be randomly divided into two groups: the experimental group (N = 33), which will receive meridian theory-based ESWT application, and the control group (N = 33) which will receive conventional ESWT treatment. These two applications will be carried out twice a week for two weeks. The primary outcome will be the Visual Analog Scale (VAS), and the secondary outcomes will be Oswestry Disability Index (ODI), Surface Electromyography (sEMG), and Patient Health Questionnaire-15 (PHQ-15). All outcomes will be evaluated at baseline and after the intervention (7 days, 14 days). Discussion: Results of this trial will contribute to providing rigorous clinical evidence for the efficacy and security of meridian theory-based ESWT for NLBP. Trial registration: Chinese Clinical Trial Registry, ChiCTR2100051049. Registered on 10 September 2021, http://www. chictr.org.cn/showproj.aspx?proj=46316. Keywords: Extracorporeal shock wave therapy (ESWT), Meridian theory, Non-specific low back pain (NLBP), Clinical trial † Yongfu Fan, Feilai Liu, and Mengna Li contributed equally to this work. *Correspondence: 2 Rehabilitation Center, The First Affiliated Hospital of Henan University of Chinese Medicine, 19# Renmin Road, Jinshui District, Zhengzhou 450000, Henan Province, China Full list of author information is available at the end of the article Background Low back pain is the major cause of dysfunction, affecting all age groups and being more common in adults [1, 2]. At the same time, the prevalence and burden of low back pain increase with age [3]. Many patients with low back pain cannot be specifically diagnosed, and approximately © The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativeco mmons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Fan et al. Journal of Orthopaedic Surgery and Research (2022) 17:265 Page 2 of 7 85% of cases cannot be attributed to specific pathological changes or nerve root irritation [4]; therefore, most patients with low back pain have NLBP [5]. Pain and dysfunction are common features of NLBP [6, 7]. At present, most treatments for NLBP have limited efficacy and a high recurrence rate [8]. The main purpose of clinical treatment of NLBP is to relieve pain and improve the quality of life of patients. There are many clinical treatments for NLBP, including conservative therapy and surgery [9–11]. Conservative therapy including bed rest, drug therapy, physical exercise, and exercise therapy can relieve NLBP to a certain extent, but there are also many drawbacks; Surgical treatment is accompanied by problems such as postoperative infection and poor long-term efficacy, and the high cost brings a heavy economic burden to patients [12]. Therefore, there is an urgent need for a safe, effective, and economical treatment for NLBP. ESWT has been extensively used for the treatment of NLBP in recent years [13, 14]. ESWT is a therapeutic method that applies shock waves to lesions from the inner body to boost blood flow and stimulate or reactivate affected connective tissue (including tendons and bones) to relieve pain and improve dysfunction [15]. Recently, based on the meridian theory of Traditional Chinese Medicine(TCM), ESWT combined with acupoint stimulation has played a therapeutic role [16]. The purpose of this study is to observe the clinical efficacy of meridian theory-based ESWT on pain and dysfunction in NLBP patients. The volunteers will complete the VAS, ODI, sEMG, and PHQ-15 assessments. The study flowchart is shown in Fig. 1. The trial process chart is shown in Table 1. Methods Study design This is a single-blind, multi-center, randomized placebocontrolled trial supported by Henan Provincial Administration of TCM. The trial will be jointly conducted by three centers in Zhengzhou, China: the First Affiliated Hospital of Henan University of CM, Henan Provincial Hospital of CM, and the Third Affiliated Hospital of Henan University of CM. Patients between 18 and 60 years of age with NLBP will be included. When participants are eligible for inclusion after being informed about the purpose and procedures of the study, they will be asked to sign an informed consent form. Then, Sixtysix patients will be recruited and randomly assigned to two groups: the experimental group (N = 33) and the control group (N = 33). Participants in the experimental group will receive ESWT based on meridian theory and participants of the control group will receive conventional ESWT treatment. Patients will be treated twice a week for two weeks. All the participants will be assessed 3 times: baseline (evaluation before treatment), the middle of the treatment (7 days after treatment star (...truncated)