Jungtae Leem1,2, Seunghoon Lee3, Yeoncheol Park4, Byung-Kwan Seo4,5,

Yeeun Cho3, Jung Won Kang3,5, Yoon Jae Lee6, In-Hyuk Ha6,

Hyun-jong Lee7, Eun-Jung Kim8, Sanghoon Lee3,5, Dongwoo Nam3,5

1. Department of Clinical Korean Medicine, Graduate School, Kyung Hee University

2. Korean Medicine Clinical Trial Center, Kyung Hee University Korean Medicine Hospital

3. Department of Acupuncture & Moxibustion Medicine, Kyung Hee University Korean Medicine Hospital

4. Department of Acupuncture & Moxibustion, Kyung Hee University Hospital at Gangdong

5. Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University

6. Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation

7. Department of Acupuncture & Moxibustion, College of Korean Medicine

8. Department of Acupuncture & Moxibustion, College of Oriental Medicine, Dongguk University

Purpose

Many patients experience acute lower back pain that becomes chronic pain. The proportion of patients using complementary and alternative medicine to treat lower back is increasing. Even though several moxibustion clinical trials for lower back pain have been conducted,theeffectiveness and safety of moxibustion intervention is controversial.

The purpose of this study protocol for a systematic review is to systematically evaluate the effectiveness and safety of moxibustion treatment compared with placebo control, conventional treatment, or no treatment in non-specific lower back pain patients evaluated by pain intensity and functional status/disability.

Figure 1. Diverse Types of Moxibustion Widely Used in Korea

Direct Moxibustion  

Moxibustion on Ginger

Indirect Moxibustion

Moxibustion on Acupuncture

Electric Moxibustion

Methods

We will conduct an electronic search of several databases from their inception to May 2017, including Embase, PubMed, Cochrane Central Register of Controlled Trial, Allied and Complementary Medicine Database, Wanfang Database, Chongqing VIP Chinese Science and Technology Periodical Database, China National Knowledge Infrastructure Database, Korean Medical Database, Korean Studies Information Service System, National Discovery for Science Leaders, Oriental Medicine Advanced Searching Integrated System, the Korea Institute of Science and Technology, and KoreaMed.

Randomized controlled trials investigating any type of moxibustion treatment will be included. The primary outcome will be pain intensity and functional status/disability due to lower back pain. The secondary outcome will be a global measurement of recovery or improvement, work-related outcomes, radiographic improvement of structure, quality of life, and adverse events (presence or absence).

Risk ratio or mean differences with a 95% confidence interval will be used to show the effect of moxibustion therapy when it is possible to conduct a meta-analysis.

Figure 2. Procedure of Systematic Review

Registration

- Systematic review protocol registration number in the PROSPERO is CRD42016047468

Search

- Electronic search

- Hand search

Analysis

- Primary outcome : Pain intensity & Functional status/disability

- Secondary outcome : global measurement of recovery or improvement, radiographic improvement of structure,work-related outcomes, quality of life, adverse events

Assessment

- According to Cochrane Risk of Bias tool by two review authors

Data synthesis

- Meta-analysis by Review Manager(REVMAN)

- Sub-group analysis : heterogeneity identification

- Sensitivity analysis : methodological quality will be assessed

Results

Our review provides a systematic, objective, and comprehensive evaluation of the effectiveness and safety of moxibustion treatment in patients with lower back pain that is non-specific.

Our review and meta-analysis provide new and useful information for practitioners, policymakers, and patients.

Various treatments with moxibustion and clinical outcomes reviewed in our study will help to design clinical trial studies of moxibustion treatment for non-specific lower back pain.

Chinese and Korean databases will also be searched to avoid a language bias.

The major limitation of our study protocol is that some of the reviewed trials may have small sample sizes; this limitation affects our objective and comprehensive assessment of the risks and benefits of moxibustion treatment for non-specific lower back pain.

Conclusions

This review will be published in a peer-reviewed journal and will be presented at an international academic conference for dissemination.

Our results will provide current evidence of the effectiveness and safety of moxibustion treatment in non-specific lower back pain patients, and thus will be beneficial to patients, practitioners, and policymakers.

This study is supported by the Traditional Korean Medicine R&D program that is funded by the Ministry of Health & Welfare through the Korea Health Industry Development Institute (KHIDI, grant HB16C0040).

Key words: Moxibustion, Non-specific lower back pain, Systematic review