Efficacy of Spinal Tuinan combined with Microneedle knife in the treatment of neurogenic cervical spondylosis: study protocol for a randomized controlled trial

doi:10.21203/rs.3.rs-2251020/v1

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Study protocol

Efficacy of Spinal Tuinan combined with Microneedle knife in the treatment of neurogenic cervical spondylosis: study protocol for a randomized controlled trial

https://doi.org/10.21203/rs.3.rs-2251020/v1

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Background

Neurogenic cervical spondylosis(NCS) is the most common type of cervical spondylosis, accounting for approximately 60 percent. Our research team has accumulated rich clinical experience in the treatment of cervical spondylosis and has carried out research related to manipulation and acupuncture therapies. This project further develops scientific research on neurogenic cervical spondylosis based on previous studies. A randomized controlled study was conducted on spinal tuina, microneedle knife, and spinal tuina combined with microneedle knife. We will observe the changes in clinical symptoms and imaging findings in patients with neurogenic cervical spondylosis by the three treatments, and evaluate the clinical efficacy and adverse reactions of the three treatments. There is great significance in guiding the clinical treatment of neurogenic cervical spondylosis.

Methods

This is a single-site, single-blind, randomized, controlled trial. A total of 90 participants will be randomly allocated to the Spinal Tuina group (Group A), Microneedle knife group (Group B) or Spinal Tuina combined with Microneedle knife group (Group C) in a 1:1:1 ratio. Patients will receive three acupuncture treatment sessions per week for 2 consecutive weeks. All patients will then receive a 4-week follow-up. Primary outcome is the effective rate. The secondary outcomes are the amount of improvement in trapezius muscle tone, the Neck Disability Index score, the Visual Analogue Score(VAS), and the cervical curvature values. Adverse events will be monitored in the treatment period and follow-up period.

Discussion

This trial may provide high-quality evidence for the efficacy and safety of Spinal Tuinan combined with Microneedle knife for NCS. The results of this study will be published in peer-reviewed journals.

Trial registration

Chinese Clinical Trial Registry ChiCTR2200061381. Registered on 7 June 2022.

Microneedle knife

Tuina

neurogenic cervical spondylosis

protocol

randomized controlled trial

Note: the numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers. The order of the items has been modified to group similar items (see http://www.equator-network.org/reporting-guidelines/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials/).

Title {1}	Efficacy of Spinal Tuinan combined with Microneedle knife in the treatment of neurogenic cervical spondylosis: study protocol for a randomized controlled trial
Trial registration {2a and 2b}.	ChiCTR2200061381. Registered on June 7th, 2022
Protocol version {3}	version 1.1(12 November 2020)
Funding {4}	Taizhou Science and Technology Bureau Fund(No.21ywb121)
Author details {5a}	¹Wenling Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine，Shanghai City, China; ²Wenling Hospital of Traditional Chinese Medicine, Wenling City, Zhejiang Province, China;
Name and contact information for the trial sponsor {5b}	Contact name: Taizhou Science and Technology Bureau Address:188, Shifu Avenue, Jiaojiang District, Taizhou City, Zhejiang Province,China Phone code: 0576-88510571
Role of sponsor {5c}	The sponsor played no part in study design; and will play no part in the collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication.

Background And Rationale {6a}

Neurogenic cervical spondylosis refers to the degenerative changes of the cervical vertebral bones and their accessory tissues under the action of various factors, and the cervical intervertebral disc protrusion and vertebral osteophytes occurred, causing changes in the normal anatomical structure of the paravertebral body. The main manifestation is the occupation of the position of the space inside and outside the intervertebral foramen, involving the spinal nerve adjacent to it, causing abnormal stimulation, compression or injury. The symptoms are neck, shoulder and back discomfort, pain, unilateral or bilateral upper limb numbness, soreness, weakness or radiating pain, abnormal sensation, etc.[1, 2] In recent years, with the modern work and lifestyle changes, the prevalence of cervical spondylosis is gradually becoming younger and is expected to become one of the highest incidence diseases of the century.[3] It brings physical and mental pain to patients and their families, and can seriously affect people's quality of life and even work efficiency, and has become a serious social problem. Epidemiological data shows that there are about one million new cervical spondylosis patients in China each year and more men than women. [4]Neurogenic cervical spondylosis is the most prevalent type of cervical spondylosis, accounting for about 60%-70% of all types of cervical spondylosis.[5]

The pathogenesis of neurogenic cervical spondylosis is not fully understood by modern medicine. It is generally accepted that the pathogenesis of neurogenic cervical spondylosis mainly includes the mechanical compression theory, the chemical inflammatory irritation theory and the autoimmune response theory.[6–11] From a modern biomechanical perspective, cervical spine biomechanical imbalance is an important cause of cervical spondylosis.[12] It is generally believed that the cervical muscles are the original driving force of the cervical spine activities, and the disorder of the dynamic balance system, mainly cervical muscle strain or degeneration, is the prerequisite for the mechanical changes of the cervical spine, which induces the degeneration of the later cervical vertebrae, intervertebral discs, small joints and surrounding ligaments.[13 ]

There are many clinical treatments for neurogenic cervical spondylosis[14], but how to choose the appropriate treatment for a patient's specific situation remains an important issue for clinicians when treating cervical spondylosis. Chinese medicine is widely used in the clinical treatment of neurogenic cervical spondylosis because of its effectiveness, safety and economic advantages. The main effects include relieving and relieving the radicular pain and numbness of neurogenic cervical spondylosis, stopping and delaying the progression of the disease, and effectively preventing and controlling the recurrence of neurogenic cervical spondylosis.[15]

Our research team has accumulated rich clinical experience in the treatment of cervical spondylosis and has carried out research related to manipulation and acupuncture treatment. This project further develops scientific research on neurogenic cervical spondylosis based on the previous studies. A randomized controlled study was conducted on spinal tuina, microneedling and spinal tuina combined with microneedling. Spinal tuina aims at solving local anatomical structures, correcting misalignments and disorders of the cervical spine bones and joints, and helping to restore the normal physiological curvature of the cervical spine[16–17]. The micro-needle knife is an emerging acupuncture tool that acts on the superficial fascia of the human body, with an incision of only 0.4mm and an entry depth of no more than 1cm, which is between the specifications of an acupuncture needle and a small needle knife, so it has both the analgesic effect of acupuncture and the relaxing effect of a needle knife, which can loosen the superficial fascia chain, reduce the expression of inflammatory cytokines, improve local microcirculation and play a comprehensive treatment role in the treatment of neurogenic cervical spondylosis.[18–19] To observe the changes of clinical symptoms and imaging findings in patients with neurogenic cervical spondylosis by the three treatments, and to evaluate the clinical efficacy and adverse reactions of the three treatments are of great significance in guiding clinical treatment of neurogenic cervical spondylosis.

Objectives {7}

Spinal Tuina has obvious advantages in improving cervical spine curvature, and microneedling has obvious advantages in improving muscle tone and pain. The combination of the two therapies can significantly improve the clinical evaluation score and improve the clinical efficacy of cervical spine disease, achieving complementary advantages.

(1)The changes in trapezius muscle tone, pain level, and cervical curvature before and after treatment were observed and analyzed to evaluate the improvement of symptoms of neurogenic cervical spondylosis in the three groups.

(2)The Visual Analogue Score(VAS), the Neck Disability Index(NDI), and the efficacy assessment were observed before and after treatment to evaluate the improvement of the three groups on neurogenic cervical spondylosis.

(3)Explore a treatment with higher efficacy ratios in all three groups.

Trial design {8}

This is a single-site, single-blinded, prospective parallel group and randomized controlled trial that conforms to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Checklist [20] and standards for Reporting Interventions in Clinical Trial of Acupuncture [21] guidelines for Acupuncture studies. A total of 90 subjects will be included and randomly assigned to the Spinal Tuina group (Group A), Microneedle knife group (Group B), Spinal Tuina combined with Microneedle knife group (Group C). Thirty subjects in each group. The flowchart of the study process is detailed in Fig. 1.

Study setting {9}

All eligible participants will undergo the trial at the Department of Acupuncture and Moxibustion, Wenling Traditional Chinese Medicine Hospital, Wenling City, Zhejiang Province, China.

Eligibility criteria {10}

Inclusion criteria are as follows: male or female aged 18 to 60 who:

must meet the diagnostic criteria for NCS as revised in the Second National Symposium on Cervical Spondylosis in 1993 and the modified criteria in the minutes of the Third National Symposium on Cervical Spondylosis in 2008[22]
no other treatment interfering with this study or taking other therapeutic drugs;
good compliance, signed informed consent form and able to cooperate with clinical treatment;
signing informed medical ethics consent form.

Exclusion criteria are as follows:

Patients with cervical spine tumor and cervical spine fracture and dislocation;
Patients with more severe symptoms such as dizziness and lightheadedness;
Pregnant women and patients with mental system disorders;
Patients with unexplained high fever and acute and chronic infectious diseases;
Patients with severe cardiovascular disease, malignant tumor, liver and kidney insufficiency;
Poor compliance, unable to cooperate with clinical treatment patients.

Who will take informed consent? {26a}

All participants will be recruited through the outpatient clinic of the Acupuncture Department of Wenling Traditional Chinese Medicine Hospital and advertising in WeChat groups, and they will be subsequently evaluated according to the inclusion and exclusion criteria. We guarantee that all participants will be fully informed and understand in detail the potential benefits and risks of the trial before they sign the informed consent.

Additional consent provisions for collection and use of participant data and biological specimens {26b}

Not applicable, this trial does not have biological specimens.

Interventions

Explanation for the choice of comparators {6b}

At present, the methods of Chinese medicine for treating nerve root type cervical spondylosis include Chinese medicine internal treatment, acupuncture, tuina, cupping, moxibustion, and small needle knife[14]. However, due to various defects such as herbal medicine is difficult to solve acute pain, acupuncture retaining needles for a long time, and small needle knife being painful and difficult to operate, the clinic is still constantly searching for a better treatment method. This program uses Spinal Tuina, Microneedle knife, and Spinal Tuina combined with Microneedle knife treatments. Spinal Tuina aims to address local anatomical structures and correct cervical spine bone and joint misalignments and disorders[23]. With the lightest force, the smallest passive spinal motion amplitude and joint manipulation to achieve the best clinical treatment effect, not only can the force penetrate deep into the soft tissues, but also can avoid the tissue damage brought by violence, which helps to restore the normal physiological curvature of the cervical spine. Micro-needle knife has both the analgesic effect of needling and the relaxing effect of needle knife, which can release the superficial fascial chain and effectively relieve the symptoms of nerve root compression[18]. Combination of two methods to bring the local imbalanced bio-mechanical equilibrium into balance, release the nerve roots and their surrounding soft tissue adhesion, change the area of the intervertebral space, adjust the relationship between the hook vertebral joints, release synovial inclusions, adjust the pressure distribution of the cervical spine tissues, enhance the stability of the cervical spine, and restore the normal physiological curvature of the cervical spine[24]. Therefore, this study will use Spinal Tuina combined with Microneedling to observe its effect on improving pain, cervical spine function, and muscle fatigue in patients with neurogenic cervical spondylosis (NCS).

Intervention description {11a}

Spinal Tuina group

Participants will take the lateral position with natural relaxation of the neck. After relaxing the soft tissues of the neck and shoulders with kneading and flicking manipulations, the doctor first extracts the patient's head and neck longitudinally for a few moments. And then, after the patient's vertebral space is opened, the thumbs of both hands coordinate to shear and push the diseased segment back and forth with light movements to correct its sagittal displacement. Finally, the Pressing and Kneading Manipulation of Tuina is applied to the Neck JiaJi Point for 10 to 15 min by using the thumb to achieve Deqi sensation. Every patient will receive 30 min of manipulation per treatment with three treatments per week for 2 weeks.

Microneedle knife group

The selected acupoints include Neck JiaJi point, Inferior occipital neckline Ashi point, First two rib surfaces Ashi point, and coracoid Ashi point.

Participants will be in the prone position. After routine sterilization, a qualified and experienced acupuncturist will enter the needles at the nodule of the acupoint, with the blade cutting parallel to the nodule of the strips one by one, at a depth of no more than 1 cm. Lifting and cutting 1-3 times depending on the size of the nodule of the strips, with the sound of "clucking" being heard during the procedure.

Every patient will receive three treatments per week for 2 weeks.

Spinal Tuina combined with Microneedle knife group

Microneedle knife manipulation is performed after the Spinal Tuina.

Every patient will receive 30 min of manipulation per treatment with three treatments per week for 2 weeks.

A follow-up visit was performed one month after the end of treatment.

Criteria for discontinuing or modifying allocated interventions {11b}

(1) Participants who withdraw on their own;

(2) Participants with poor compliance;

(3) Development of other medical conditions affecting treatment or serious adverse events.

Strategies to improve adherence to interventions {11c}

At the beginning of the trial, participants will be informed of the experiment procedure again. They can report their personal feelings at any time during the study, and we will give corresponding feedback as appropriate to increase the interactivity and then improve adherence to interventions.

Relevant concomitant care permitted or prohibited during the trial {11d}

No other treatments may be used to treat throughout the study.

Provisions for post-trial care {30}

At the end of the study, we will provide certain amount of subsidy to each subject. If the adverse events occur during the trial that related to the intervention after the expert committee confirms, the responsible department will provide corresponding economic compensation, psychological comfort, and treatment modalities. Before the trial, the participants will be informed that participation in this study is voluntary, they can withdraw from the study at any time for any reasons, and their benefits will not be affected.

Outcomes {12}

Primary outcome

The overall effectiveness rate of treatment is the primary outcome of this study. Assessed according to the “Criteria for Diagnosis and Treatment of Diseases in Traditional Chinese Medicine”(ZY/T001.1—94)：

(1) Healing: The original cervical spine pain symptoms and signs disappear, the activity function returns to normal, and can participate in normal study and work;

(2) Effective: Clinical symptoms and radicular pain signs basically disappeared;

(3) Improvement: Reduction the signs and symptoms of cervical spondylosis and improvement the function of cervical movement;

(4) Useless: No improvement in cervical spine movement function, signs and symptoms still exist.

The overall effectiveness rate = (healing + effective + improvement)/total number of cases × 100%.

Secondary outcomes

Trapezius muscle tone measurement will be used to evaluate the level of muscle fatigue in participants. The area under the curve (AUC) is used to describe the value. Amount of improvement in muscle tone = AUC value at the end of the session - AUC value before treatment.

The visual analogue score is done by drawing a straight line on a piece of white paper, with one end representing a score of 0 and 1 end representing a score of 10, and allowing the patient to choose a score based on their subjective feelings. Zero means the patient has no pain; below 3, indicates moderate pain; 4 to 6, more significant pain; and 7 to 10, very severe and unbearable pain.[25]

Lateral cervical spine X-rays will be used to observe changes in cervical curvature in participants. The cervical curvature values of participants were measured by Borden's method. The normal neck curvature value is (12±5) mm. Less than 7 mm is the physiological curvature becoming smaller; more than 17 mm is the physiological curvature becoming larger. When the neck curvature value is 0 means the physiological curvature becomes straighter. When the neck curvature value is negative means the physiological curvature becomes reversed.[26]

The NDI(Neck Disability Index score) is a self-assessment instrument of the specific functional status of subjects with neck pain with 10 elements that include pain, personal care, weight gain, reading, headache, concentration, work, driving, sleeping, and leisure. Each section is rated on a scale of 0 to 5, where 0 means “painless” and 5 means “the worst pain imaginable.” The points obtained are added to a total score. The questionnaire was interpreted as a percentage. The disability categories for NDI are 0–8%, without disability; 10–28%, mild; 30–48%, moderate; 50–64%, serious; and 70–100%, complete.[27-28]

Participant timeline {13}

The timing of intervention and data collection is detailed in Table 1.

Table 1. The recommended SPIRIT table with the participant timeline. 0= baseline= pre-acupuncture; t1 = during acupuncture; t2 = post-acupuncture; t3= follow-up visit

	STUDY PERIOD
	Enrolment	Allocation	Post-allocation		Close-out
TIMEPOINT**	*-t₁*	0	t₁	t₂	t₃
ENROLMENT:
Eligibility screen	X
Informed consent	X
Initial evaluation	X
Allocation		X
INTERVENTIONS:
*Spinal manipulation*			X
*Microneedle knife*			X
*Combination treatment*			X
*X-ray*		X		X
*Muscle tone test*		X		X
ASSESSMENTS:
*AUC*		X		X	X
*Cervical curvature*		X		X	X
*VAS*		X		X	X
*Neck Disability Index*		X		X	X

Sample size {14}

The study used G∗Power version 3.1 software for sample estimation and selected the F-test, which was calculated using the MANOVA model.[29] Effect size = 0.30, α=0.05, power = 0.92, group size 3 and number of repeated measures of 2 were selected to generate a sample size of 81. Taking into account a possible attrition rate of 11% during the trial, the final sample size was obtained as 90 and was allocated in a ratio of 1:1:1, that is, 30 cases in each group.

Recruitment {15}

All participants will be recruited through the outpatient clinic of the Acupuncture Department of Wenling Traditional Chinese Medicine Hospital and advertising in WeChat groups.

Assignment of interventions: allocation

Sequence generation {16a}

This experiment will adopt the method of block randomization. An independent researcher who is not in contact with the participants will use the software SPSS23.0 to generate a random number table to divide the 90 eligible participants into Spinal Tuina group (Group A), Microneedle knife group (Group B), Spinal Tuina combined with Microneedle knife group (Group C) with a 1:1 :1 ratio.

Concealment mechanism {16b}

After the sequence number is generated, the researcher will make allocation cards and seal each card in an opaque envelope. The envelope will be kept by the same researcher responsible for sequence generation.

Implementation {16c}

An independent researcher that is blinded to the study protocol will generate the allocation sequence. According to the timing sequence of the participant registration for the trial, another researcher will arrange the participants into different groups and inform the acupuncturists of the group assignments.

Assignment of interventions: Blinding

Who will be blinded {17a}

The implementation of the double-blind method is relatively difficult due to the specificity of the experimental treatment instrument. Ensure that randomized groupers, treatment operators, efficacy observers, and data collectors are trained and operated separately during trial implementation.

Procedure for unblinding if needed {17b}

Unmasking is not needed.

Data collection and management

Plans for assessment and collection of outcomes {18a}

The measurement and collection of outcomes in this study include oblique muscle tone graphs, lateral cervical spine x-rays, VAS Analogue Score, Neck Disability Index score and total effective rate of treatment. The trapezius muscle tone graph will be measured with the WK-MTIMS-01Mini, a muscle tone meter developed by Ultimate Medical, which has been used in numerous clinical trials. Each scale is internationally recognized. The evaluation standard of total effective rate is issued by the Medical Secretary of the State Administration of Traditional Chinese Medicine, which is accurate and reliable. All physicians who enroll participants and assessors who collect data must attend training to ensure the use of identical practices.

Plans to promote participant retention and complete follow-up {18b}

Every patient will receive three treatments per week for 2 weeks. A follow-up visit was performed one month after the end of treatment. The VAS scales and trapezius muscle tone charts will be collected at the follow-up to assess pain and any recurrence of muscle fatigue in the month following the end of treatment. To promote participant retention and a complete follow-up action plan, all costs of treatment and testing will be reimbursed to participants upon completion of the full trial process. All baseline information on participants who discontinue or deviate from the intervention protocol for any reason, as well as the information that has been collected, will be carefully documented and properly maintained.

We will set up data monitoring committees (DMCs). These will protect trial participants by ensuring that they are not unduly or unfairly at risk of harm and ensure that the scientific integrity of the trial is maintained. The DMC is an independent advisory group that is essential to ensure unbiased assessment of accumulating trial data. The DMCs, which generally comprise medical and statistical experts with experience in clinical trials, will be developed in accordance with the World Health Organization Operational Guidelines for the Establishment and Functioning of Data and Safety Monitoring Boards.

Data management {19}

We will use a clinical trial management platform called ResMan to manage the original data, which will be collected and double-entered by blinded assessor. The data management system will be tested before the officially launched and will be protected by password. The original data of participants will be entered within 1 week after finishing the trial. Data supervisor will check every trial data at least once a month to make sure that they will be recorded accurately, timely, and completely.

Confidentiality {27}

This protocol, CRFs, and other documents and materials related to the study will be kept strictly confidential and will not be disclosed to third parties except with the consent of the Principal Investigator. Any public report on this study will not disclose the subjects’ personal identity, and we will make every effort to protect the privacy of participants’ personal medical information within the sphere permitted by law. The staff in this study is also bound by this agreement.

Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}

Not applicable, this trial does not have biological specimens.

Statistical methods

Statistical methods for primary and secondary outcomes {20a}

Data analyses will be performed with the statistical software SPSS23.0 by an independent statistician. The analysis will include an intention-to-treat(ITT) analysis, including data for all participants who dropped out of the trial. Descriptive statistical analysis will be used for all demographic and clinical characteristics of subjects such as sex, age, and weight. We will validate the homogeneity of demographic characteristics and examine the variables among the 3 groups. The Kolmogorov–Smirnov test of normality was used for all continuous variables in the 3 groups, and if mean±SD were used, the 3 groups had to be normally distributed. Comparisons between groups were made using MANOVA. Posthoc tests were undertaken using the SNK method and within-group comparisons were conducted using the paired samples t test. If the data did not conform to a normal distribution, comparisons between groups were made using a nonparametric test for paired samples, and comparisons between groups were made using a nonparametric test for multiple samples. The chi-squared test is adopted to analyze categorical data. The significance level used for statistical analysis with 2-tailed testing will be 5%.

Interim analyses {21b}

Not applicable. Interim analyses will not be performed in this study.

Methods for additional analyses (e.g. subgroup analyses) {20b}

Not applicable. The trial has no plan for additional analyses.

Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}

All data in this study will be analyzed according to the principle of ITT to reduce deviation, including the subjects who withdraw from the study during the study period. The missing data will be substituted into the subjects’ baseline data for final data analysis.

Plans to give access to the full protocol, participant level-data and statistical code {31c}

The data sharing process will comply with the principles of good practice, and the data sharing will be conducted in accordance with the regulatory requirements.

Oversight and monitoring

Composition of the coordinating center and trial steering committee {5d}

Not applicable. There is no coordinating center and trial steering committee of this study.

Composition of the data monitoring committee, its role and reporting structure {21a}

To guarantee the quality of this RCT, it will be carried out in a professional setting at the Wenling Hospital of Traditional Chinese Medicine. We will promptly input the data on ResMan website. Working as the data monitoring team, the Shanghai University of Traditional Chinese Medicine Joint Training Center will identify problems in the trial, examine collected data, and control bias. A qualified clinical trial specialist will be invited to monitor this study.

Adverse event reporting and harms {22}

Any adverse events related to the intervention will be reported by participants and practitioners. Details of each adverse event will be registered by the Scientific Research Supervision group of the Wenlin Hospital of Traditional Chinese Medicine and chronicled in a case report form. Adverse events include any symptoms or diseases that are unexpected throughout the duration of the RCT. All subjects in the trial will receive a certain amount of compensation.

Frequency and plans for auditing trial conduct {23}

The monitoring Committee is entitled to review and inspect the relevant materials of the trial and supervise the implementation process by telephone, email, or video regularly to ensure that the study is carried out according to the protocol.

Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25}

Any modifications that may have an impact on the study, potential benefit to patients, or affect patient safety, including changes of the study objective, study design, patient population, sample size, or study procedure will require a formal revision of the study protocol. This will be decided jointly with the monitoring Committee and the Joint Training Center and approved by the Ethics Committee.

Dissemination plans {31a}

The publication of the outcomes of this study will provide baseline data, Lateral cervical spine X-rays and Trapezius muscle tension map. The outcomes may be presented at conferences, symposiums, teaching classes, etc., if applicable.

The causes of NCS are many and complex, and in the early stages of clinical practice, it was thought to be associated with mechanical compression, inflammatory responses of the nerve roots, or autoimmune reactions.[29] As research progressed, it was found that in the physiological state, the spinal cord, nerves and blood vessels are in a delicate balance of relaxation and fixation both inside and outside the spinal canal; there is a large space not only laterally but also anterior and posterior in the spinal canal.[30] However, when degeneration occurs in the cervical spine, there is an imbalance between the bony flab and bony canal (eg, vertebral canal, vertebral artery canal, nerve root canal) and tissues within the canal (eg, spinal cords, nerves, blood vessels, etc) and the soft tissues around the neck, which has become a key trigger for the development of cervical spondylosis.[31] There are many clinical treatments for neurogenic cervical spondylosis(NCS), but how to choose the appropriate treatment for a patient's specific situation remains an important issue for clinicians. All major evidence-based guidelines cite non-surgical therapies as the first line of treatment[32–35]. Non-surgical treatment mainly includes medication and physical therapy. Medications include non-steroidal anti-inflammatory drugs(NSAIDs), opioid analgesics, and hormone injections. However, long-term medication is prone to adverse effects such as gastrointestinal ulcers and hypertension, and hormone injections carry the risk of nerve damage[36–37]. The efficacy of physical therapy is not stable enough, and the recurrence rate is high. Chinese medicine treatment for NCS includes: traditional Chinese medicine, acupuncture, tuina, cupping, moxibustion, small needle knife, etc. But due to various drawbacks such as the difficulty of herbal medicine to resolve acute pain, the long needle retention time of acupuncture, and the difficulty and pain of small needle knife, there is still a clinical need to find a better treatment method.

Micro-needle knife as a new type of therapy, is a kind of action on the human body superficial fascia relaxation, micro-needle knife incision is only 0.4mm, into the needle depth of no more than about 1cm, specifications between the acupuncture needles and small needle knife. Therefore, it has both the analgesic effect of acupuncture and the relaxing effect of needle knife. It is safe and fast-acting, and can make up for the shortcomings of various clinical treatments. Furthermore, Micro-needle knife therapy can inhibit the expression of inflammatory cytokines by reducing the levels of interleukin 6 and some inflammatory factors.[38] And micro-needle knife can peel off soft tissue adhesions and scarring through local release, improve microcirculation, change the tissue ischemia and hypoxia, eliminate sterile inflammation metabolism, and restore dynamic balance. Micro-needle knife therapy also has some restorative effect. When the soft tissues are released during the treatment, some of the severed muscle fibers will gradually regrow and form new ones[39]. Spine tuina is the result of combining traditional techniques with the essence of foreign chiropractic care. Spine tuina emphasis on adjusting the lines of force in the human spine. The lightest force, the smallest passive spinal motion and joint manipulation are used to achieve the best clinical results. The technique is now widely used in clinical practice. It is a simple, easy-to-operate, low-risk, and fast-acting treatment method. Thus, in this study, micro-needling combined with spinal tui-na technique was adopted. We planned to observe the clinical efficacy and explore whether it is the first choice for conservative treatment of NCS.

There are some limitations in this randomized controlled trial. This study could only be a single-blind trial due to the specificity of the intervention. For participants, their subjective consciousness will affect the outcomes, which is unavoidable.

Trial status

We started recruiting participants in July 2022 and the recruitment is expected to end in June 2023. The protocol version 1.1, which has approved by the Ethics Committee of Wenling City Hospital of Traditional Chinese Medicine on 12 December 2020.

VAS: Visual Analogue Score

NDI: Neck Disability Index

AUC: Area Under the Curve

PASS: Power Analysis and Sample Size

DMCs: Data Monitoring Committees

ITT: Inention-To-Treat

NCS: Neurogenic Cervical Spondylosis

NSAIDs: Non-Steroidal Anti-Inflammatory Drugs

SPIRIT: Standard Protocol Items Recommendations for Interventional Trials

Acknowledgements

Not applicable.

Authors’ contributions {31b}

The trial design was developed by LYF and HLW. LYF drafted the manuscript, which was carefully revised, edited, and discussed by HJL and ZXL. All authors read and approved the final manuscript.

Funding {4}

This RCT is funded by grants from the Taizhou Science and Technology Bureau Fund(No.21ywb121).

Availability of data and materials {29}

The datasets analysed during the current study will be available from the corresponding author on reasonable request.

Ethics declarations

Ethics approval and consent to participate {24}

The trial has been approved by the Ethics Committee of Wenling Hospital of Traditional Chinese Medicine, and is registered with Chinese Clinical Trials Registry (ChiCTR2200061381). Written informed consent will be attained from each participant.

All approaches will be conducted in accordance with the guidelines and provisions in the Declaration of Helsinki.

Consent for publication {32}

Consent for publication of images in this study will be obtained from participants. We also make relevant instructions in the CRF to ensure that each subject is aware of the details. Refer to supplementary material.

Competing interests {28}

The authors declare that they have no competing interests.

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No competing interests reported.

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Efficacy of Spinal Tuinan combined with Microneedle knife in the treatment of neurogenic cervical spondylosis: study protocol for a randomized controlled trial

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Background And Rationale {6a}

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Trial design {8}

Methods: Participants, Interventions And Outcomes

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