Study Design
The present study employs a single-center, randomized, and analyst-blinded controlled trial with two arms: the Tuina group (control) and the Baduanjin combined with Tuina group (intervention). The protocol has received approval from the Ethics Committee of Jiangsu Provincial Hospital of Traditional Chinese Medicine, affiliated with Nanjing University of Traditional Chinese Medicine(project number:2023NL-211-02). A total of 82 eligible patients with chronic non-specific neck pain (NCNP) will be recruited and randomly assigned to either group in a 1:1 ratio. All patients will provide written informed consent. Independent researchers blinded to the patient assignments will be responsible for collecting and analyzing the outcome assessments and related data. The study design is schematically represented in Fig 1.The primary treatment center will be the Tuina Department of Jiangsu Provincial Hospital of Traditional Chinese Medicine.
By employing a rigorous and controlled design, this study aims to provide accurate and reliable evidence on the efficacy of Baduanjin combined with Tuina therapy in the management of chronic non-specific neck pain. The ethical approval ensures that the rights and welfare of the participants are safeguarded throughout the study.
Participants and Recruitment
Eligible participants must meet the diagnostic criteria for non-specific neck pain (NCNP) as outlined in the foundational guidelines for chiropractic treatment of adults with neck pain, summarized by the GDC of Canada [21]. Patients experiencing non-specific neck pain for more than three months (with no relief for more than two weeks) who visit the Tuina Department of Jiangsu Provincial Hospital of Traditional Chinese Medicine for the first time will be informed about this trial. If a patient expresses interest in participating, a clinical trial coordinator will promptly engage them in contract negotiations and provide a brief overview of the trial. If the patient decides to participate, they will undergo a face-to-face interview in the outpatient clinic of the Tuina Department at Jiangsu Provincial Hospital of Traditional Chinese Medicine. Once the patient has signed the informed consent form, they will be enrolled in the trial if they meet the inclusion criteria.
To recruit potential participants, we will utilize the following strategies:
1)Posting of posters in the Tuina Department of Jiangsu Provincial Hospital of Traditional Chinese Medicine
2)Promotion on WeChat platforms
Inclusion Criteria
Eligible participants must meet all of the following criteria to be enrolled in the study:
1)Age range of 20 to 50 years.
2)Both male and female individuals are eligible.
3)Presence of current neck pain localized to the cervical or bilateral scapular region.
4)Negative results on the neck distraction test, Spurling's neck compression test, and Adson's test.
5)Neck pain symptoms lasting for at least 3 months.
6)Visual analog scale (VAS) score of 3 or higher and Neck Disability Index (NDI) score of 10 or higher at the time of recruitment.
7)No prior history of shoulder or neck surgery and no accompanying shoulder problems.
8)Willingness to actively participate in the study.
Exclusion Criteria
Participants meeting any of the following criteria will be excluded from this trial:
1)Specific cervical spine disorders, including disk prolapse, spinal stenosis, postoperative conditions, cervical radiculopathy, or myelopathy.
2)History of whiplash injury or head/neck injuries.
3)Pregnant women or those who have had a recent delivery.
4)Patients who have responded to prior treatment, particularly those with neck pain radiating into the arm and whose arm pain has resolved with an injection or medication.
5)History of severe trauma, spasmodic torticollis, frequent migraine, fibromyalgia, shoulder diseases, inflammatory rheumatic diseases, tumor, osteoporosis, psychiatric illness, or obvious spinal deformity or neurological disease.
6)No clinical treatment for neck pain in the past 3 months.
7)Participants who are unable to speak or write Chinese to complete the questionnaires.
8)History of alcohol or drug abuse.
9)Subjects who experience discomfort or adverse reactions to Tuina therapy.
10)Regular practitioners of Qigong, or Yoga in the past 3 months.
11)Poor cooperation or unwillingness to adhere to the study protocol.
Dropout Criteria
Participants who fail to complete the clinical protocol due to the following reasons shall be deemed as dropouts:
1)Patient withdrawal due to poor treatment efficacy or adverse reactions.
2)Loss of follow-up contact.
3)Removal of the patient by researchers due to poor compliance or occurrence of serious adverse events.
Comprehensive Suspension Criteria
The trial will be suspended under the following circumstances:
1)Discovery of a significant safety issue by the investigators.
2)Assessment of a poor therapeutic effect at Week 4.
3)Identification of a major mistake in the study plan.
4)Encountering significant funding or management issues by the sponsor.
Randomization and Allocation Concealment
The randomization list will be generated using a random number generator from Strategic Applications Software, version 9.4 (SAS Institute Inc., Cary, NC, USA). These random numbers will be placed in sequentially numbered opaque envelopes.
Prior to random assignment, the research team will document detailed information about each participant at the clinical center. This documentation includes participant details such as name, date of birth, participant and center codes, and the date of inclusion. This information will be recorded during the reporting and preparation of a signed informed consent form.
The therapist will sequentially open the envelopes and allocate participants accordingly. After the baseline assessment, eligible participants will be randomly assigned to the experimental group and the control group in a 1:1 ratio.
Blinding Procedure
Patients will be informed about the type of treatment they will receive. While the therapists will be aware of the allocation, they will undergo training to ensure effective blinding of treatment during communication with patients. To minimize bias, evaluators, data managers, and statisticians involved in result evaluation procedures and data analysis will remain unaware of the group assignments throughout the process. The blinding procedure will remain in effect until the data are locked.
Interventions
The Tuina protocol utilized in this experiment mirrors the one taught in textbooks for students at universities specializing in traditional Chinese medicine. This protocol encompasses techniques for manipulating soft tissue and the spine, such as rolling, pressing, and tapping. Furthermore, the Baduanjin treatment for NCNP patients has been customized based on a textbook widely used as a standard educational tool for students of Traditional Chinese Medicine. [22,23].
Participant Intervention
Patients assigned to the Tuina or the Baduanjin combined with Tuina groups will receive Tuina therapy thrice weekly for four consecutive weeks. To ensure the comfort of participants, the treatment room temperature will be maintained at a comfortable range of 23°C to 25°C. Before the Tuina session begins, patients will be allowed 15 minutes to relax and unwind. They will be instructed to lie down in a prone position during the treatment.
The intensity of the Tuina sessions will be tailored to each patient based on a comprehensive assessment of their physical examination results, the therapist's clinical expertise, and individual discussions with each patient. Each Tuina treatment session will span 25 minutes, ensuring a thorough and effective therapy experience.
Baduanjin Intervention Protocol
Patients assigned to the Baduanjin-Tuina combined group will participate in Baduanjin exercises three times weekly for a four-week duration. Weekly group sessions will be held, during which patients will converge to practice Baduanjin together, guided by a Baduanjin expert. The expert will demonstrate the proper techniques and correct any deviations in form. Additionally, patients are instructed to perform Baduanjin twice weekly at home.
To facilitate their practice, patients will receive a digital video disk containing customized instructions for Baduanjin movements specifically designed for this study. This resource will allow them to review and improve their techniques at home. Patients are encouraged to record their practice sessions and submit them to the expert via email or WeChat for feedback and guidance.
Each Baduanjin session will span 30 minutes. To assess the treatment's effectiveness, VAS, NDI, and AROM evaluations will be conducted at baseline and at weeks 2, 4, and 8.
Tuina group
In this study arm, the Tuina therapist will follow a three-step protocol to alleviate neck pain and restore neck function. This protocol emphasizes relaxing the neck and shoulder soft tissue to reduce discomfort and improve neck flexibility. Here are the detailed steps:
Step 1: Soft Tissue Manipulation
Patients are asked to lie down and relax both their bodies and minds. Prior to treatment, the therapist performs a comprehensive postural and palpatory assessment to assess the characteristics of chronic neck pain. Subsequently, the therapist employs a relaxing manipulation technique, pressing and kneading the stiff muscles and soft tissue of the neck and shoulders for 5 minutes. Following this, gentle rolling of the trapezius muscle with the palms is applied for another 5 minutes to alleviate tension in the back area. The aim of this step is to resolve muscular adhesions and enhance overall blood circulation.
Step 2: Acupoint Manipulation with Clicking Technique
The therapist focuses on specific acupoints—GB20, DU16, GB21, ST12, SJ11, and SI14—and applies a combination of pressing and kneading techniques for 2 minutes each. This technique is designed to alleviate Qi stagnation and eliminate blood stasis by dispersing adhered fascicles. The force applied is adjusted based on the patient's perception of Deqi, which is typically experienced as a dull pain, heaviness, numbness, or soreness. This sensation is widely recognized as an indicator of effective manipulation in acupuncture and Tuina therapies [24,25].
Step 3: Spinal Manipulation
After relaxing the muscles and soft tissues through the preceding steps, the Tuina therapist proceeds to spinal manipulation. At this stage, the patient is instructed to adopt a safe sitting position. Initially, the therapist gently applies torsional force to align the patient's neck and employs a shaking motion to further loosen the area. Subsequently, with one thumb pressed on the deviated spinous process and the other palm supporting the lower jaw, the therapist performs gentle traction and twisting movements, maintaining this position for a brief moment. This is followed by a sudden pulling motion to extend the neck by 5 to 10 degrees. The objective of this manipulation is to restore alignment and flexibility to the neck, thereby further alleviating pain and discomfort.
Baduanjin Combined with Tuina Group
Within this arm of the study, the Tuina treatment protocol remains consistent with the Tuina group. However, a Baduanjin instructor will introduce an eight-step protocol aimed at enhancing therapeutic outcomes and promoting harmony between physical and mental states. The core movements of Baduanjin are visually represented in Fig 2, which showcases the fundamental postures and sequences of this ancient Chinese exercise routine.
Step 1: Propping up the Sky
1) Stand with feet parallel and shoulder-width apart. Raise both arms slowly from the sides of the body until they are straight above the head, with the palms facing each other and fingers crossed. Turn the palms upwards and push them up as if stretching, making sure not to tense the arms. This position resembles stretching like doing a yawn. Simultaneously, raise the head slowly and gaze upwards, maintaining a posture as if holding up the sky. Inhale slowly during this process.
2) Turn the palms downwards and lower them slowly in front of the body until they reach chest height. As they descend, turn the palms back upwards. Gently lower the head and follow the movement of the hands with your eyes. Exhale slowly during this motion.
Repeat this upward and downward palm motion four to eight times.
Step 2: Drawing the Bow
1) Stand with feet parallel and slightly wider than shoulder-width, adopting a horse stance position. Keep the upper body upright and both arms bent at the chest level, with the left arm on top and the right arm below.
2) Grip the fists tightly, spreading the index finger and thumb apart in an eight-shaped manner. Slowly push the left hand out to the left, straightening the left arm, while bending the right elbow and pulling it back towards the right, stopping the right fist in front of the right ribcage with the palm facing up, resembling the action of drawing a bow. Look at the left hand.
3) and 4) Repeat the same movements as in 1) and 2), but with the left and right sides reversed. Perform this action four to eight times on each side.
Step 3: Raising One Hand
1) Raise the left hand in front of the body into a vertical position and extend it upwards with the palm facing upwards. Then turn the palm outwards and push it up, with the fingertips pointing to the right. Simultaneously, press the right palm downwards with the fingertips pointing forwards.
2) Lower the left hand in front of the body with the palm facing downwards, guiding the flow of Qi downwards and relaxing the whole body. Return to a natural standing position.
3) and 4) Repeat the same movements as in 1) and 2), but with the left and right sides reversed. Perform this action alternately with each hand four to eight times.
Step 4: Looking Behind
1) Stand with feet parallel and shoulder-width apart. Let the arms hang naturally by the sides or cross them over the waist. Gradually twist the head and neck to the left, leading the spine to follow, while looking over the shoulder. Inhale deeply during this movement.
2) Slowly turn the head and neck to the right, guiding the spine to follow, and return to a forward-facing gaze. Exhale and relax the whole body.
3) and 4) Repeat the same movements as in 1) and 2), but with the left and right sides reversed. Perform this action four to eight times on each side, looking behind to the left and then to the right.
Step 5: Punching and Glaring
1) Stand in a horse stance with hands on hips. After exhaling slowly, twist the waist to the left and bend forward, exhaling the remaining breath. Without pausing, move the head from the lower left side, passing in front of the body, to the lower right side. Imagine scooping water with a small ladle as you extend the neck forward. Slowly raise the head from the right side while inhaling. Twist the waist back to the left, returning to the horse stance, and exhale deeply. Relax the whole body during the exhalation. At the end of the exhalation, perform a rhythmic pinching action on the waist with both hands several times.
2) Repeat the same movements as in 1), but with the left and right sides reversed.
Alternate between 1) and 2), performing each action four to eight times.
Step 6: Pulling the Toes
1) Stand with feet parallel and shoulder-width apart. Place both palms on the sides of the navel.
2) Move both palms along the abdomen towards the back of the waist.
3) Slowly lean forward, keeping the knees straight, while the palms massage downwards along the coccyx and inner thighs to the heels. Then, massage along the outer sides of the feet to the inner sides.
4) Straighten the upper body while massaging both hands along the inner thighs back to the sides of the navel. Repeat this bending and straightening movement four to eight times.
Step 7: Search the Clouds
Starting Position: Stand with feet apart in a horse stance. Hold both fists at the waist with the knuckles facing upwards, and keep the eyes wide open.
1) Slowly punch the left fist forward, either as a closed fist or an open palm. When punching, twist the waist slightly to the right, and allow the left shoulder to naturally follow this movement. As the arm extends, turn the palm outwards and then curl the fingers back into a fist. Bring the fist back to the waist in a circular motion, with the knuckles facing upwards.
2) Repeat the same movement as in 1), but with the left and right sides reversed. Perform this alternating punching action four to eight times on each side.
Step 8: Bouncing on the Toes
Starting Position: Stand with feet parallel and shoulder-width apart, or with the feet touching each other.
Raise both arms from the sides of the body up over the head while lifting the heels off the ground and inhaling simultaneously. Then, let the arms fall back down in front of the body while lowering the heels back to the ground and exhaling. Relax the whole body during this movement. Repeat this raising and lowering action four to eight times.
Study therapists
Sessions of Tuina will be conducted by a highly skilled therapist, proficient in Tuina techniques and holding a practitioner's license for over five years. Similarly, sessions of Baduanjin will be led by an experienced teacher with five years of teaching expertise. Both the Tuina therapist and Baduanjin teacher will undergo a thorough one-week training program, successfully completing a comprehensive assessment to maintain uniformity in study methods. This ensures the highest standards of service delivery and consistency throughout the study protocol.
Concurrent Treatment Allowance for Patients
During the trial, patients are prohibited from undergoing any additional treatment for NCNP, whether it be pharmacological or non-pharmacological. Nevertheless, they are allowed to seek treatment for conditions unrelated to neck pain. Any changes or adjustments made to their concurrent treatments will be meticulously recorded.
Outcome Measurements
To compare the effectiveness of the two groups, the primary outcome measure will involve monitoring changes in the visual analog scale (VAS) at four key time points: weeks 0, 2, 4, and 8 (as outlined in Table 1). Furthermore, secondary outcomes will also be assessed at these four intervals, encompassing the Neck Disability Index (NDI) and the SH-105 scale to evaluate cervical active range of motion (AROM). These comprehensive measurements will provide insightful data on the patients' progress and response to treatment.
Table 1 All measurements and measuring time points
Primary Outcome Measurement:
VAS
The Non-specific chronic neck pain (NCNP) severity will be gauged using a 10-cm horizontal Visual Analog Scale (VAS). Patients will be prompted to answer the question, "How much pain do you currently experience?" and mark their response accordingly on the VAS. A score of zero signifies "no pain," whereas a score of 10 indicates "extreme pain."[25].
The VAS has been established as a reliable and precise instrument for assessing pain intensity, exhibiting an Intra-Class Correlation (ICC) ranging from 0.96 to 0.98 in prior research. This ensures consistency and reproducibility in measuring patients' perception of pain[26].
Secondary Outcome Measurements:
Neck Disability Index (NDI)
The Neck Disability Index (NDI) is a self-reported questionnaire widely used to assess the impact of neck dysfunction on patients' daily activities [27]. It comprises 10 questions, with each question offering six possible answers ranging from 0 (no disability) to 5 (complete disability). The total NDI score spans from 0 to 50 points, providing a comprehensive measure of patients' functional limitations due to neck pain.
The interpretation of the total NDI scores offers a clear picture of patients' disability levels. Scores below 4 indicate no disability, while scores ranging from 5 to 14 suggest mild disability. Scores of 15 to 24 represent moderate disability, and scores from 25 to 34 denote severe disability. Scores exceeding 35 point to complete disability. This quantitative measure effectively captures the impact of neck pain on patients' daily activities, enabling a precise assessment of neck dysfunction.
Active Range of Motion (AROM)
The Spain ScanTM SH-105 device, manufactured by Ad-Or Medical Technologies Ltd. in Israel, offers an accurate measurement of the active range of motion in the cervical spine. This device has undergone extensive validation by numerous researchers, ensuring its reliability and reproducibility [28,29].
During the measurement procedure, the patient is seated with a straight back, leaning against the chair's backrest. The goniometer, which is integrated with a computer and utilizes Bluetooth technology for data transmission, is positioned at the center of the cranial region. Once the researcher activates the device and presses the "start/end" button, the patient is instructed to flex forward to their maximum limit, stopping when any pain symptoms arise. The researcher then presses the "start/end" button again, prompting the computer to automatically capture the data.
This process is repeated three times for each movement: flexion-extension, lateral flexion, and rotation. Finally, the mean value of each movement is calculated and recorded, providing a comprehensive assessment of the patient's cervical spine motion.
Safety Evaluation
Patient safety will be rigorously monitored throughout each visit during the clinical trial and implementation. This oversight will be achieved through the collaborative efforts of two attending physicians and two spine care specialists, who will guide clinicians in every step of the process. The Endpoints Adjudication Committee, composed of two chief spinal surgeons, will oversee the overall execution of the clinical trials.
Any adverse events (AES) that occur during the trial, such as changes in pain, syncope, vertigo, or disability, will be promptly addressed. Regardless of whether an AES is attributed to the intervention, treatment will be immediately suspended. Patients experiencing adverse events will receive necessary medical assistance to alleviate their symptoms. It is crucial that all adverse events are promptly reported to the responsible unit and the Ethics Committee of the Jiangsu Provincial Hospital of Traditional Chinese Medicine, affiliated with Nanjing University of Traditional Chinese Medicine.
If an adverse event is confirmed to be study-related, the Ethics Review Committee has the authority to suspend the study. In such cases, medical experts will be engaged to conduct a thorough assessment and investigation to determine the actual cause. Ensuring the well-being of our patients is paramount, and appropriate medical and financial compensation will be provided to any participants affected by adverse events.
Follow-Up
To evaluate the long-term impact of the intervention, a one-month follow-up period has been designated post-treatment. During this crucial phase, patients will not receive any additional treatment, and they will not be directly supervised by researchers.
To maintain regular communication and monitor progress, the outcome assessor will initiate contact with patients weekly through various channels such as WeChat, telephone, email, or other convenient means. This regular contact ensures that patients are kept updated on the follow-up process and are reminded to participate actively.
At the end of each week, patients will be invited to visit the designated reception room to complete the previously mentioned scales. These scales, designed to assess various parameters such as pain level, functional capacity, and overall well-being, provide crucial data for evaluating the intervention's long-term effects.
Concurrently, measurements of tissue hardness and Active Range of Motion (AROM) will be conducted. These measurements offer objective insights into the physiological changes that may have occurred due to the intervention. By combining both subjective and objective data, a comprehensive picture of the intervention's long-term outcomes can be obtained.
It is important to note that the follow-up period serves not only to assess the efficacy of the intervention but also its safety. Any adverse events or unexpected outcomes reported by patients during this period will be promptly investigated and addressed. This ensures that the safety of patients is always a top priority throughout the entire study.
Sample Size Calculation for Comparing Two Groups
H0:μ1 − μ2 ≤ Δ;H1:μ1 − μ2 > Δ
(where μ1 represents the VAS score after 4 weeks of treatment in the Tuina group, and μ2 denotes the VAS score after 4 weeks of treatment in the combined Tuina and Baduanjin group.)
Based on a prior clinical study conducted in China [30], the mean VAS score in the Tuina group, consisting of 34 patients, was 5.5 with a standard deviation of 1.1. Similarly, the mean VAS score for the group that received a combined treatment of Tuina and neck exercises, also with 34 patients, was 4.7 with a standard deviation of 1.3.
To determine the appropriate sample size for this randomized controlled trial (RCT), we carefully considered several key parameters. Using G*Power 3.1.9.7, we estimated the necessary sample size. We set the α level of significance at 0.05 and the β level of power (or type II error) at 0.20. Employing a superiority design and a two-sided test, we assumed a minimum difference (Δ) of 0 between the two groups. Furthermore, we anticipated a dropout rate of 20%.
Taking into account these parameters and assuming a normal distribution, we calculated the required sample size per group, incorporating the expected dropout rate, to be 41 cases. Consequently, a total of 82 participants, with 41 in each group, should be recruited for this RCT. This ensures sufficient statistical power and accuracy in assessing the difference between the Tuina group and the group receiving a combination of Tuina and Baduanjin.
Statistical analysis
All statistical analyses for this study will be meticulously conducted using SPSS software version 24.0 (SPSS Inc., Chicago, IL, USA) by independent statisticians blinded to the research team and group allocations. This approach ensures unbiased and rigorous analysis of the collected data.
Adhering to the intention-to-treat (ITT) principles, we will set statistical significance at a p-value of less than 0.05. Participants who fail to complete the study will be assumed to have experienced no change from their baseline measurements, reflecting a conservative approach to data interpretation.
Descriptive statistics will be employed to compare demographic and baseline information, assessing the comparability of the groups. The Kolmogorov-Smirnov test will be used to assess the normality of the data. Depending on the results of the homogeneity and normality tests, we will choose either parametric statistics (such as the Tukey test) or non-parametric statistics (like the Wilcoxon rank sum test) for within-group and between-group comparisons. In cases where data does not follow a normal distribution, a covariance analysis will be conducted to adjust for potential confounding factors.
To assess efficacy, we will evaluate four distinct time points. A repeated measures analysis of variance (ANOVA) will be utilized to analyze changes in dependent variables across baseline and follow-up measurements. To handle multiple comparisons, we will employ the Bonferroni and Dunn tests. For intra-group comparisons, i.e., changes from baseline to follow-up, a two-sided paired t-test will be used.
Categorical variables, including VAS, NDI, and AROM scores, as well as adverse effects between groups, will be analyzed using the chi-square test or Fisher's exact test, depending on the nature of the data. Numerical data will be presented as the mean ± standard deviation (SD), while categorical variables will be summarized using percentages.
If needed, post hoc analyses will be conducted to further explore significant findings or unexpected patterns in the data. The confidence interval will be set at 95%, maintaining a high level of confidence in our results. Overall, this rigorous statistical approach aims to provide accurate and reliable insights into the effectiveness and safety of the interventions under study.
Data Collection and Management
Outcome assessors will be responsible for collecting data using Case Report Forms (CRFs), which will capture questionnaire-based assessments of treatment effects, Active Range of Motion (AROM), tissue hardness, adverse events, and safety evaluations. This ensures that all relevant information is systematically recorded and available for subsequent analysis.
To maintain the integrity and accuracy of the data, two independent data administrators, who are unaffiliated with the research team and blinded to group allocation, will be involved in the data entry process. These administrators will receive rigorous training in data monitoring to ensure that they are proficient in handling the data effectively.
After completing the CRFs, the data will be entered into an Excel database managed by Microsoft, located in Redmond, Washington, USA. This choice of software ensures the use of a widely recognized and reliable platform for data storage and management.
Once the data is entered, it will be uploaded in real-time to the China Clinical Trial Registry (http://www.chictr.org.cn). This registry utilizes an electronic data management system that allows for real-time tracking and monitoring of test data. The Science and Technology Department of Jiangsu Provincial Hospital of Traditional Chinese Medicine, affiliated with Nanjing University of Traditional Chinese Medicine, will be responsible for maintaining and overseeing this system, ensuring that the data is securely stored and accessible for analysis.
By following these procedures, we aim to ensure the highest level of data quality and integrity, which is crucial for drawing accurate and reliable conclusions from the study.
Quality Control
Quality control measures are paramount in ensuring the reliability and validity of the study. Therefore, throughout the duration of the research, rigorous quality control practices will be implemented.
The head of the research center will play a pivotal role in overseeing the coordination, development, and quality assurance of all programs within the trial. This individual will ensure that all aspects of the study adhere to the highest standards of quality and comply with ethical and regulatory requirements.
To further enhance the quality of the data collected, independent reviewers, who are unaffiliated with the researchers and sponsors, will be engaged. These reviewers will randomly select 10% of the case reports from the Clinical Research Forms (CRFs) to conduct quarterly audits. The audits will be meticulous and comprehensive, focusing on identifying any potential logic issues, validating test values, and carefully examining any abnormal safety indicators post-treatment. Missing values will be addressed, compliance will be assessed, and the normative, completeness, and consistency of the data will be thoroughly checked.
To ensure that all team members are equipped with the necessary skills and knowledge to carry out their duties effectively, all research team members will undergo professional training prior to the commencement of the study. This training will cover all aspects of the research, including data collection, entry, and analysis, as well as ethical considerations and regulatory requirements.
Any proposed corrections or revisions to the protocol will be carefully considered. These changes will be reviewed and discussed by the Ethics Committee of Jiangsu Provincial Hospital of Traditional Chinese Medicine, affiliated with Nanjing University of Traditional Chinese Medicine. The committee will ensure that any modifications made are in line with ethical and regulatory standards and will maintain detailed records of all changes made.
By implementing these quality control measures, we aim to minimize errors and ensure that the study produces accurate and reliable results. This, in turn, will enhance the credibility of our findings and contribute to the advancement of scientific knowledge in the field.
Ethical considerations
This study focuses on collecting data from patients suffering from non-specific chronic neck pain (NCNP), and obtaining informed consent from all participating patients is a prerequisite. Patients retain the right to withdraw their participation at any stage. The presentation of the trial results will solely involve tables and figures, ensuring that no identifying information about individual participants is disclosed. The data collected through this study will be strictly confined to the research's objectives, and the entire research team is firmly committed to upholding ethical confidentiality principles.
Moreover, we will diligently address any ethical concerns that may arise throughout the study. We firmly believe that the benefits of this research outweigh any potential risks involved. The trial has received approval from the Ethics Committee of Jiangsu Provincial Hospital of Traditional Chinese Medicine, affiliated with Nanjing University of Traditional Chinese Medicine (approval number:2023NL-211-02). Additionally, the trial has been registered on ChiCTR with the registration number 2400083714. We are fully committed to adhering to ethical standards and ensuring the welfare of all participants involved in this study.