Acupuncture therapy for chronic low back pain: protocol of a prospective, multi-center, registry study

Xuqiang Wei,Jincao Zhou,Hong Zhao,Baoyan Liu,Liyun He,Xingyue Yang,Jia Liu

doi:10.1186/s12891-019-2894-4

Abstract

ObjectiveAcupuncture therapy for chronic low back pain (CLBP) has received increasing attention. Nevertheless, the evidence of efficacy and safety of random controlled trials (RCTs) remains controversial. Acupuncture as a complex intervention influenced by many factors, its effectiveness in treating chronic low back pain in the real world is unknown. We will develop a network-based registry study to evaluate the effectiveness and safety of acupuncture for the treatment of chronic low back pain and explore key factors affecting efficacy in the real world.MethodsA prospective, multi-center and dynamic registry study. All acupuncture related information will be collected through a high-quality structured network platform. Patients with CLBP included in the study met the following criteria: age from 16 to 80 years, using acupuncture as a main therapy and voluntarily signing the informed consent. At least 2000 patients, 27 acupuncturist, and 9 medical centers will be recruited under actual clinical settings at the first stage. Numeric rating scale (NRS), Oswestry Disability Index (ODI) and Effective rate will be measured in pain and functional disability assessment, respectively, as the primary outcome. Evaluation index will be collected at the baseline and follow-up in 1, 4, 12 weeks after the last visit. Hierarchical models and regression analysis will be used to explore the key factors affecting acupuncture effectiveness. Effects between propensity matching groups (Traditional Chinese acupuncture style vs Microacupuncture style, Local acupoint selection vs Non-local acupoint selection, Single Acupuncture vs Combined therapy) will be compared.DiscussionThis study will be conducted based on the characteristics of acupuncture therapy in the “Real World”. Fundamental factors affecting the clinical effectiveness of acupuncture and the preferred acupuncture regimen in the treatment of CLBP will be identified. Reliable acupuncture evidence for the treatment of CLBP through the registry will be a significant supplement to the RCTs.Trial registrationChinese Clinical Trial Registry, ChiCTR-OOC-17010751 and Acupuncture-Moxibustion Clinical Trial Registry, AMCTR-OOO-17000045. Registered date on 3 December 2016.

Highlights

As a consequence of the acceleration of global aging, sedentary lifestyle increasing and average weight gain, chronic low back pain (CLBP) has become a global condition with high incidence
Numeric rating scale (NRS), Oswestry Disability Index (ODI) and Effective rate will be measured in pain and functional disability assessment, respectively, as the primary outcome
This study will be conducted based on the characteristics of acupuncture therapy in the “Real World”

Summary

Introduction

As a consequence of the acceleration of global aging, sedentary lifestyle increasing and average weight gain, chronic low back pain (CLBP) has become a global condition with high incidence. Disability and financial burden attributed to chronic low back pain is substantially different between countries, the incremental impact of the worldwide health care system predicted to tremendously in the coming decades [1]. According to 2015 global statistics, low back pain accounts for 7.3% point prevalence of activity-limiting illnesses, affected 5.4 billion people at all ages [2]. CLBP accounts for a significant portion of the $100 billion spent annually on treatment in the United States [3]. Effective and safe treatment is especially crucial in overcoming low back pain and disability related to the chronic condition

Methods

Findings

Discussion

Conclusion