Study Protocol Systematic Review Medicine ®

OPEN

The efficacy and safety of fire needle for cervical

spondylotic radiculopathy
A protocol for systematic review and meta-analysis
Kaiyang Xue, MMa,b , Hong Liu, MMa,b, Qiumei Shi, MMa, Xianzhu Wang, MMa,b, Yanqin He, MMa,b,
∗
Jin Cui, PhDa , Jing Fu, PhDa,

Abstract
Background: Cervical spondylotic radiculopathy (CSR) is one of the most common types of cervical spondylosis, and its
treatments are mainly for relieving radicular pain and improving dysfunction. The existing randomized controlled trials (RCTs) suggest
that fire needle may be a potential therapy in the treatment of CSR, but there is no evidence-based medical evidence to date.
Therefore, this study will systematically evaluate the efficacy and safety of fire needle in the treatment of CSR.
Methods: We will search for 7 electronic databases (PubMed, EMBASE, Cochrane library, China National Knowledge
Infrastructure, Chinese Scientific Journals Database, Sinomed, and Wanfang Database) and 2 trial registration platforms
(ClinicalTrials.gov and Chinese Clinic Trials.gov) to collect eligible studies. The RCTs related to fire needle for CSR and published up to
June 30, 2021 will be included, regardless of language. We will consider the visual analogue scale as the primary outcome and the
secondary outcome will include cervical range of motion, assessment of muscle strength, neck disability index, the MOS item short
from health survey, activities of daily living, total efficiency, and adverse reactions. We will use the standard proposed in Cochrane
Handbook 5.1.0 to assess the quality and bias risk of every RCT, and all analyses will be conducted through RevMan software V5.3
(Copenhagen: Nordic Cochrane Center, Cochrane, Collaborative Organization, 2014).
Results: This systematic review and meta-analysis will provide a convincing synthesis of existing evidences on the efficacy and
safety of fire needle for CSR, and the results will be submitted to a peer-reviewed journal for publication.
Conclusion: The results of this study will provide high-quality evidence of fire needle in the treatment of CSR for clinical decision-
making.
INPLASY registration number: INPLASY202170041.
Abbreviations: CSR = Cervical spondylotic radiculopathy, RCTs = randomized controlled trials.
Keywords: cervical spondylotic radiculopathy, fire needle, meta-analysis, protocol, systematic review

1. Introduction roots due to degenerative changes in cervical bone, intervertebral

discs, ligaments, facet joints and other accessory tissues.[1]
Cervical spondylotic radiculopathy (CSR) is a syndrome
Among them, as many as 80% of patients presented with C6 or
characterized by compression of one or more adjacent nerve
C7 root involvement.[2] The occurrence of CSR is mostly
associated with the aging of the population, contemporary social
KX and HL contributed equally to this work.
pressure, and lifestyle, which performs pain along the cervical
This research was funded by the Science and Technology Research Project of
Traditional Chinese Medicine and Ethnic Medicine of Guizhou Administration of
nerve roots, dyskinesias, paresthesias, and weakened reflexes.[3]
Traditional Chinese Medicine (NO: QZYY-2018-043). With the progression of the disease, severe cases may have muscle
The authors have no conflicts of interest to disclose. atrophy, or even loss of upper limb function, resulting in a decline
Data sharing not applicable to this article as no datasets were generated or
in productivity and quality of life.[4,5] The incidence of CSR
analyzed during the current study. accounts for about 60% to 70% of all cervical spondylosis,
a
Guizhou University of Traditional Chinese Medicine, Guizhou, China, b The First which is the most common type of cervical spondylosis in clinical
Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guizhou, practice. A recent systematic review of the epidemiology of CSR
China. shows that the prevalence of CSR ranged from 83 to 179 per
∗
Correspondence: Jing Fu, Guizhou University of Traditional Chinese Medicine, 100,000 people, and the prevalence of females is higher than that
Shi Dong Road No. 50, Guiyang 550002, Guizhou, China of males.[6,7]
(e-mail: fujing4648@126.com).
Currently, the treatment strategies recommended by the
Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc. guidelines for CSR contain surgical and conservative treatment,
This is an open access article distributed under the Creative Commons
Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and
including traction, drugs, massage, acupuncture and moxibus-
reproduction in any medium, provided the original work is properly cited. tion, and physical therapy, etc.[8–10] The survey shows that the
How to cite this article: Xue K, Liu H, Shi Q, Wang X, He Y, Cui J, Fu J. The success rate of surgical treatment is between 80% and 95%,[11]
efficacy and safety of fire needle for cervical spondylotic radiculopathy: a protocol among which discectomy and fusion are more commonly
for systematic review and meta-analysis. Medicine 2021;100:31(e26824). used.[12] However, 4% of postoperative patients experienced
Received: 15 July 2021 / Accepted: 16 July 2021 adverse events such as reduction of intervertebral disc height and
http://dx.doi.org/10.1097/MD.0000000000026824 degeneration of adjacent segments.[13] In recent years, surgical

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Xue et al. Medicine (2021) 100:31 Medicine

methods for CRS have been continuously optimized and the  The experimental group is treated with fire needle alone, while
number of operations has continued to increase, but the exact the control group accepts other therapies.
indications of surgery and the advantages of surgery compared  The experimental group is treated with fire needle combined
with conservative treatment have not been definitely verified.[14] with other therapies, while the control group accepts the same
More than 75% of patients can significantly improve their other therapies.
condition within 3 months with conservative treatment, which
remains the first choice for most patients with CSR.[15,16] Among 2.2.4. Outcomes
them, acupuncture and moxibustion therapy including fire needle 2.2.4.1. Primary outcomes. The primary outcome is visual
has become a commonly used clinical therapy due to its analogue scale.
outstanding curative effect, non-toxic side effects and economic
benefits.
2.2.4.2. Secondary outcomes. The secondary outcomes are
The origin of fire needle can be traced back to the pre-Qin
cervical range of motion, assessment of muscle strength, neck
period. It is a kind of external treatment method that uses heated
disability index, the MOS item short from health survey, activities
needles to stimulate acupoints or lesions quickly to cure
of daily living, total efficiency, and adverse reactions.
diseases.[17–19] This method combines the mechanical stimulation
of acupuncture and the warm stimulation of moxibustion, which
can achieve synergistic effects. It has the effects of warming the 2.3. Data sources and search strategy
meridians, dispelling cold and dehumidifying, and invigorating
The following 7 electronic databases and 2 trial registration
yang, and is often used clinically for nerve damage, motor
platforms will be searched to collect eligible studies published up
dysfunction and dermatological diseases. Studies have shown
to June 30, 2021: PubMed, EMBASE, Cochrane library, China
that fire needle can effectively relieve radicular pain,[20]
National Knowledge Infrastructure, Chinese Scientific Journals
somatosensory disorder,[21] disabled physical activity[22] and
Database, Sinomed, Wanfang Database, ClinicalTrials.gov and
other CSR-related symptoms, and its mechanism may be related
Chinese Clinic Trials.gov. We will use various combination of
to the intervention of pain conduction, regulation of inflamma-
medical subject headings and free words to search for terms such
tory response and improvement of local blood circulation. Fire
as “cervical spondylotic radiculopathy”, “ cervical radiculopathy
needle can down-regulate the levels of pain transmitters such as 5-
”, and “fire needle”, a search strategy in PubMed will be
hydroxytryptamine and substance P in the central and peripheral
demonstrated in Table 1.
nervous systems,[23,24] as well as the levels of tumor necrosis
factor and interleukin-1 in serum,[25–27] and mobilize the body to
release more vascular endothelial growth factor involved in 2.4. Data collection and analysis
trauma recovery actively to promote the repair of nerve damage 2.4.1. Study selection. After using Endnote X9 (Clarivate
or stimulating symptoms.[28] Analytics US LLC) to exclude repetitive literatures, 2 researchers
So far, the efficacy and safety of fire needle in the treatment of will independently read the title and abstract, conduct a
CSR have not reached a consensus. The aim of this study is to preliminary screening based on the inclusion criteria, and then
evaluate the efficacy and safety of fire needle for CSR by check the full text to determine whether it will be included. If
systematically reviewing and analyzing the currently available there is any disagreement, further discussion and verification will
randomized controlled trial (RCTs), which will provide evidence be conducted, or the third researcher will assist in the resolution.
support for clinical decision-making. The details of screening process will be shown in the preferred
reporting items for systematic reviews and meta-analysis flow
chart (Fig. 1).
2. Methods
2.1. Study registration
The protocol has been registered on the INPLASY platform
(Registration Number: INPLASY202170041, https://inplasy. Table 1
com/inplasy-2021-7-0041). We will report this protocol accord- Search strategy in PubMed.
ing to the preferred reporting items for systematic reviews and No. Search terms
meta-analysis protocols statement guidelines.[29] 1 Cervical spondylotic radiculopathy [mh]
2 Cervical spondylotic radiculopathy [tw]
2.2. Inclusion and exclusion criteria 3 Cervical spondylosis [tw]
2.2.1. Type of study. We will include the RCTs which 4 Cervical radiculopathy [tw]
evaluating the efficacy and safety of fire needle for CSR in any 5 Cervical syndrome [tw]
6 Nerve root cervical spondylosis [tw]
language, whether published or not. Others such as randomized
7 Cervical spine radiculopathy [tw]
crossover trials, animal trials, medical cases, and only published
8 #1 or #2 or #3 or #4 or #5 or #6 or #7
in the form of abstracts will be excluded. 9 Fire needle [tw]
10 Fire needle therapy [tw]
2.2.2. Participants. We will include participants who are clearly
11 #9 or #10
diagnosed with CSR according to any recognized diagnostic
12 Animals [mh]
criteria, without restrictions on age, gender, profession, ethnicity, 13 Humans [mh]
and source of cases. 14 #8 and #11
15 #12 not #13
2.2.3. Interventions and controls. Two types of RCTs will be
16 #14 not #15
included:

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Figure 1. PRISMA-style flow chart of literature screening. PRISMA = preferred reporting items for systematic reviews and meta-analysis.

2.4.2. Data extraction. Two researchers will independently 2.4.4. Managing missing data. If there is data missing in the
complete the data extraction work through a table containing the literature, try to contact the original author through e-mail or
following information: publishing features (title, first author, telephone, and get the relevant information needed. If it is not
year of publication, institutional units, journals), participants and available, it will be explained in the article.
interventions (baseline data, randomization and blinding,
treatment site, adverse events, follow-up time), outcomes data. 2.4.5. Data synthesis. The Revman 5.3 statistical software
The data will be cross-checked after extraction and any disputes provided by the Cochrane Collaborative network will be used to
will be resolved by discussion with a third researcher. summarize and analyze the data included in the literature. Mean
difference will be used as the statistic of continuous data. Relative
2.4.3. Risk of bias assessment. This study will use the bias risk risk will be used as the statistic of the dichotomous data. Both
assessment tool in the Cochrane Handbook 5.1.0 to assess the continuous data and dichotomous data are expressed in terms of
risk of bias.[30] The content includes 7 items, such as random effect size and its 95% confidence interval.
sequence generation method, allocation concealment method,
blinding of clinicians and patients, blinding of outcome 2.4.6. Assessment of heterogeneity. In this study, the Cochran
evaluators, data integrity, selective reporting, and other sources Q test (qualitative) and I2 statistical test (quantitative) will be used
of bias. According to the literature information, the risk of bias to test the heterogeneity of the results of each study. When there
will be judged to be low, high, and unclear. Two researchers will are no dominant heterogeneity (P > .1, I2 < 50%), the fixed effects
assess the risk of bias repeatedly and independently, then cross- model will be used for analysis. When there are significant
check the results. Any differences will be determined by heterogeneity in the results (P < .1, I2 > 50%), the random effects
consulting a third party. model will be used for analysis, and the sensitivity analysis or

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subgroup analysis will be conducted to identify possible sources strict literature screening, standard bias risk assessment, scientific
of heterogeneity. data analysis, and objective quality assessment. We believe that
the results of this systematic review can provide high-quality
2.4.7. Subgroup analysis. Based on the clinical experience evidence for clinicians to make decisions and help enhance the
in the application of fire needle, when there is significant quality of life of CSR patients.
heterogeneity in the analysis results, we will conduct subgroup
analysis according to the basic characteristics of the patients and
the treatment course to explore the potential sources of Author contributions
heterogeneity.
Conceptualization: Jing Fu.
2.4.8. Sensitivity analysis. In order to verify the robustness of Funding acquisition: Jin Cui.
the meta- analysis results, we will remove the included literatures Investigation: Qiumei Shi, Xianzhu Wang, Yanqin He.
in order of quality from low to high, and recombine the effect Methodology: Kaiyang Xue, Hong Liu.
sizes to compare with the previous analysis results. If there is no Writing – original draft: Kaiyang Xue, Hong Liu, Jing Fu.
significant change in the results of the combination, the results of Writing – review & editing: Jing Fu, Jin Cui.
the meta-analysis are reliable. If the results of the combination
change significantly, the sensitivity is high and the results are not References
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