STRENGTHS AND LIMITATIONS OF THIS STUDY
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Non-penetrating blunt needles will be used for the sham acupuncture intervention to minimise the impact of the placebo effect of acupuncture.
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Treatment will be administered using acupoints on the healthy side, which involves fewer acupoints and has easier application.
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The study does not involve a drug-treatment control group.
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The study does not include a follow-up assessment.
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The study is being conducted at a single centre.
Introduction
Stiff neck, also known as ‘Laozhen’ in China, is mainly characterised by pain and limited neck movement.1 It can severely impact patients’ quality of life and daily activities during acute attacks and is often caused by incorrect sleeping positions, uncomfortable pillows or exposure to cold in daily life. Stiff neck belongs to the category of neck pain in modern medicine. Neck pain is a common health concern that more than 30% of individuals experience each year, and has a higher prevalence in females than in males (approximately 27.2% in females and 17.4% in males).2–4 Almost 50% of the population experiences neck pain in their lifetime with frequent recurrences.5 6 It was ranked as the fourth-leading cause of years lived with a disability in 2016.7
At present, the clinical treatment for stiff neck is based on the use of traditional pharmaceuticals such as non-steroidal anti-inflammatory drugs and muscle relaxants, but there are limitations such as long treatment cycles, slow onset of action (roughly 30 min) and a high recurrence rate with these treatment modalities.8–10 In some cases, patients do not receive timely and effective treatment for acute attacks and eventually develop chronic neck pain.3 5 Thus, there is an urgent need for a treatment that can rapidly alleviate the symptoms of acute neck pain and improve neck movement. Non-pharmacological treatments such as acupuncture and massage are increasingly being used to treat stiff neck.11 12
Acupuncture is the primary non-pharmacological treatment in Chinese medicine, and its efficacy in pain management has been widely recognised. It has shown definite effectiveness not only in chronic pain,13–17 such as neck pain, low back pain, migraines, dysmenorrhoea and postoperative pain but also in acute pain.18 Exercise therapy is another form of non-pharmacological treatment and is often recommended to help alleviate pain and restore or improve body function.19 Patients experiencing acute episodes of stiff neck urgently require rapid pain relief and improved neck movement. In our clinical practice, we have observed that the combination of acupuncture and active exercise during treatment can yield positive results in a short period. Some patients have experienced significant pain relief and improved neck movement after 10 min of treatment. However, there is currently a lack of rigorous randomised controlled trials (RCTs) in clinical practice to confirm this finding.
Objectives
This trial aims to evaluate the immediate efficacy of acupuncture combined with active exercise therapy for patients suffering from acute stiff neck (ASN) within 10 min.
Methods and analyses
This study has been approved by the Ethics Committee of the Second Affiliated Hospital of Yunnan University of Chinese Medicine (2022-009).
Study design and setting
This single-centre and randomised controlled clinical trial will be conducted in the Second Affiliated Hospital of Yunnan University of Chinese Medicine. Overall, 120 participants with ASN will be randomly allocated to three groups, including acupuncture combined with active exercise group (group A), sham acupuncture combined with active exercise group (group B) and active exercise group (group C), in a 1:1:1 ratio. Both groups B and C are control groups in this trial. All participants will undergo one 10 min session. A study flow chart is presented in figure 1. The enrolment, intervention and assessment schedules are presented in table 1.
Flow diagram.
Study schedule for data measurements
Recruitment and informed consent
All participants will be recruited from the outpatient department of The Second Affiliated Hospital of the Yunnan University of Chinese Medicine and Kunming community via online and offline channels, such as WeChat public accounts, websites and public announcements. Before participation in the study, all participants will receive comprehensive information about the study’s objectives and procedures and all participants will be required to provide written informed consent (online supplemental file 1). They will have the right to withdraw from the trial at any time without providing a reason.
Supplemental material
Study population
Inclusion criteria
Patients meeting all of the following criteria will be included in the analysis: (1) diagnosis of stiff neck and patient in the acute phase; (2) age between 18 and 60 years; (3) 4≤pain Visual Analogue Scale (VAS) score ≤9 and (4) voluntary participation in the study with informed consent.
Exclusion criteria
The following patients will be excluded from the analysis: (1) patients with disease onset of more than 7 days, according to the International Association for the Study of Pain20; (2) patients with cervical spine fracture, dislocation, tuberculosis or tumour; (3) patients with severe cardiovascular and cerebrovascular diseases; (4) pregnant women or patients with skin allergies; (5) patients with a history of syncope who are unable to undergo acupuncture treatment; (6) patients who are unconscious, unable to express subjective discomfort symptoms and those with mental illness; (7) patients with severe local lesions (such as infection, burn and scald) that cannot be treated with acupuncture; (8) patients who have received analgesic treatment and (9) patients who are intolerant or uncooperative to exercise therapy.
Removal criteria
(1) Patients who do not meet the inclusion criteria and are included by mistake; (2) patients whose trials are terminated because of severe adverse events (AEs) or complications, making further treatment inappropriate and (3) patients who choose to withdraw from their participation in the study should be excluded.
Randomisation and blinding
Random numbers will be generated by using SPSS V.28.0 (IBM, authorisation Code: f56b44b8d8e3562ad8a2) by an independent statistician, and the sealed envelopes will be sequentially numbered from 1 to 120 by an independent investigator to conceal the group assignments. Participants will be informed that they will be randomly assigned to different groups and will be treated in separate rooms to avoid communication. Blinding assessments will be conducted for both acupuncture groups at the end of treatment. In this trial, outcome assessors and statisticians will be blinded. However, because of the specific nature of acupuncture treatments, acupuncturists will not be blinded throughout the study process. Blinding can only be revealed in certain situations, such as when the pain does not improve or if it worsens.
Intervention
Intervention measures will be in accordance with the Consolidated Standards of Reporting Trials21 and the Standards for Reporting Interventions in Clinical Trials of Acupuncture.22 As per the theory of Chinese medicine and clinical experience, the stiff neck sites are believed to involve three meridians: the sanjiao meridian of hand Shaoyang, the small intestine meridian of hand Taiyang and the large intestine meridian of hand Yangming. Thus, Shu and specific points of the three meridians will be selected as the prescription. These include Shousanli (LI10), Houxi (SI3) and Zhongzhu (TE3) acupoints. These acupoints will be positioned based on the WHO Standard Acupuncture Point Locations 2010 (ISBN: 1101119787117123327). The locations of the acupoints are presented in table 2 and figure 2.
Location of acupoints
Location of acupoints. SI3, Houxi; TE3, Zhongzhu; LI10, Shousanli.
Appliance selection
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Acupuncture needle (see figure 3): the Huatuo brand disposable acupuncture needles sized 0.25 mm×40 mm and manufactured by Suzhou Medical Supplies Factory, China will be used. Manufacturer licence number: Su Food and Drug Administration of Machinery Production 20010020; Registration certificate number: 201622770970.
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Park Sham Acupuncture Device (PSD) (see figure 3) includes transparent guide tubes (Φ 4×20 mm, Φ 3×35 mm), double-sided tape (Φ 1×15 mm) and opaque plastic bases (Φ 4×15 mm, Φ 5×10 mm) sourced from Suzhou Medical Supplies Factory, China (lot number 210401).
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Blunt needle (see figure 3): Retractable stainless steel blunt needles (0.25×40 mm), sourced from Suzhou Medical Supplies Factory, China (lot number 210401) will be used.
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Protractor crafted from stainless steel, measuring 90×155 mm sourced from Huzhou, Zhejiang, China (lot number LJQ915D) will be used.
Park Sham Acupuncture Device, needle and sham needle.
Procedures
Before the procedure, the participants will be instructed to be in a seated position, fully exposing the acupoints and the operator will then perform routine disinfection. The procedure will be conducted by a licensed acupuncturist with at least 3 years of experience.
Group A
PSD+acupuncture needle will be used. The rubber band on the PSD surface will be removed, and a disposable acupuncture needle will be inserted to expose the needle tip. The needle will then be placed and secured on the acupoints before piercing the skin. The acupuncture needle will be rapidly inserted to a depth of 0.5–0.8 cun, and lifting, thrusting and twisting techniques will be employed to elicit the sensation of acquiring qi.23 Subsequently, we will instruct the participants to perform neck, shoulder, back and upper limb exercises on the affected side with reference to the Neck Pain24: clinical practice guideline.24 Neck exercises will mainly include anteflexion, rear protraction, right and left lateral flexion, and rotation (see figure 4A), and upper limb exercises will comprise clockwise rotation and counterclockwise rotation with the elbow flexed inward (see figure 4B). Participants are primarily instructed to perform repetitive rotational, flexion-extension and lateral flexion movements of the cervical spine. Cervical movements are accompanied by repetitive movements of the upper limbs in either a clockwise or anticlockwise direction (see figure 4C), with upper limb movements leading to shoulder movements. Each direction will be repeated 3–5 times, alternating at 30–60 s intervals. The above movements will be controlled within the participant’s tolerance range. During the treatment period, two skilled research assistants will rapidly collect participants’ cervical range of motion (ROM) and the VAS score for pain at 0–1, 2, 4, 6, 8 and 10 min into the treatment session. The data collection table is shown in online supplemental file 2. It is important to note that all exercises must be carried out within the participant’s tolerance.
Supplemental material
Operation diagram.
Group B
PSD+a blunt needle will be used in this group. The rubber band on PSD surface will be removed, and the flexible blunt needle will subsequently be inserted and fixed on the acupoints. The needle will not pierce the skin, but the participants will feel the sensation of acupuncture without any other manipulation. The participants in group B will similarly be instructed to perform neck, shoulder, back and upper limb exercises on the affected side, following the same procedure as that followed in group A.
Group C
Acupuncture operation will not be performed, and the participants will be directly instructed to perform neck, shoulder, back and upper limb exercises on the affected side as in group A.
The duration of the operation for all the three groups will be 10 min. During the treatment session, an impartial medical assistant will carefully record the data in real time, ensuring that the medical assistant remains unaware of the follow-up result evaluation. This method guarantees the integrity of the data collection process and maintains impartiality during the evaluation phase. Data will be collected at baseline and at the end of the treatment session (after 10 min) (online supplemental file 2).
Emergency treatment
During the study, if a participant’s pain is not relieved or if it worsens during treatment, the treatment will immediately be discontinued. Emergency analgesics such as ibuprofen or other necessary emergency treatments will be given, and the treatment details will be carefully recorded on the case report form (CRF). Participants in groups B and C will receive acupuncture or other emergency treatment after the study.
Outcomes
Primary outcome
The primary outcome is the effective rate following 10 min of treatment. The effective rate is calculated as the proportion of participants whose pain score on the VAS decreases by at least 50% and who experience a 50% improvement in neck movement compared with baseline.25
Secondary outcomes
The secondary outcomes include the effective rate at various time points (0–1, 2, 4, 6 and 8 min), VAS score and ROM.
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The VAS is an assessment tool that helps determine the level of pain of participants on a continuous line of 10 cm, ranging from no pain to the worst possible pain26 (online supplemental file 2). A higher score on the VAS indicates more severe pain. Studies have shown that the minimum detectable change (MDC) in VAS values used to measure neck pain is often between 2 and 4 points.27 28
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ROM is one of the basic indices used to evaluate the ROM of the cervical spine, and it will be used to measure the ROM of the neck during flexion, extension, lateral flexion and rotation29 (online supplemental file 2). Studies have shown that the MDC in cervical ROM is 10°.30 31
The other outcomes include blinding assessment and treatment expectations scale.
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To test the participant-blinding effects, participants in group A and group B will be asked at the end of treatment whether they believe they received true acupuncture treatment. In addition, they will be asked to rate their confidence in their answer on a scale of 0–10, where 0 indicates very uncertain and 10 indicates completely certain (online supplemental file 3).
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The treatment expectations scale assesses the expectations of participants with regard to acupuncture treatment outcomes. Before treatment, participants will indicate their anticipated treatment result (either ‘effective’ or ‘ineffective’) and rate their perception of receiving a positive treatment and the expected outcome on a scale of 0–10 (online supplemental file 3).
Supplemental material
Sample size
To the best of our knowledge, there is currently no experimental study that has directly compared the efficacy of acupuncture and sham acupuncture in ASN. Therefore, we have referred to a previous study on acupuncture for acute pain and our own clinical experience for sample size estimation for this study.32 We anticipate the effective rates of acupuncture combined with neck movement group, sham acupuncture combined with neck movement group, and neck movement groups to be 70%, 40% and 30%, respectively, 10 min after treatment. Accordingly, we have set α=0.025 (unilateral), β=0.1, Δ=0.06 and K=1. We have calculated the required sample size for each group using the following formula33 :
According to the formula, it is estimated that at least 37 participants will be required per group. Considering an anticipated 8% drop-out rate, a total of 120 participants will be needed, with 40 participants in each group.
Statistical analysis
The clinical data will be analysed using SPSS V.28.0 software by a statistician. Qualitative data will be described using percentages or proportions, using the χ² test. Quantitative data will be expressed as mean±SD. For continuous variables, t-test or Wilcoxon rank sum test will be performed, and χ² test or Fisher’s exact test will be performed for categorical variables. Differences among the three groups will be assessed via one-way analysis of variance (ANOVA), and non-parametric tests will be employed for data that do not follow a normal distribution. For longitudinal and repeat measurement data, repeated measures ANOVA will be performed. The intention-to-treat principle will be applied while evaluating the baseline characteristics and primary and secondary outcomes. To assess whether changes in the measured variables were clinically relevant, we calculated the MDC for each variable. The MDC was calculated based on the standard error of measurement (SEM) with the formula 1.96×√2×SEM.34 Specifically, the MDC for VAS scores ranged from 2 to 4 points, whereas the MDC for cervical mobility (ROM) was 10°. In future analyses of results, only changes above the MDC were interpreted to ensure reliability and clinical relevance of the results. The missing data, for participants who withdraw from the study, will be made up using multiple replacement methods. A two-sided test with p value of 0.05 will be considered significant.
Data management and confidentiality
To effectively manage clinical data, both printed and electronic CRFs will be used. A clinical research associate will be responsible for verifying the accuracy of data, checking for any missing information and ensuring data consistency. Only outcome assessors will have access to the CRFs, thereby safeguarding the personal information of potential and enrolled participants. Further, a regular report of trial progress will be made to maintain quality control, and the research leader will check all trial processes. The ethics committee will consistently review the trial’s progress and oversee the collection, allocation and concealment of data. The committee possesses the authority to make necessary modifications or terminate the trial, and it maintains a conflict-free relationship with the sponsor.
Quality control
Each researcher will participate in the professional training for protocols, methods of acupuncture manipulation, exercise instructions and data management to ensure the quality of the trial and the consistency of the study.
AE reporting and safety monitoring
Throughout the study, participants receiving acupuncture treatment may experience AEs such as pain, subcutaneous congestion or haematoma, local infection, broken needles, or even syncope or other severe events. These AEs will promptly and appropriately be managed, regardless of whether they are directly related to the treatment in this study. All AEs will be documented in detail in the CRFs, and a comprehensive report will be submitted to the ethics committee. A comparative analysis of AEs between groups will be conducted using χ2 test or Fisher’s exact test.
Patient and public involvement
None.
Trial status
The trial is set to commence recruitment and treatment from 1 January 2023, with an anticipated completion date of 30 June 2025.
Ethics and dissemination
This research received ethical approval from the Ethics Committee of the Second Affiliated Hospital of Yunnan University of Chinese Medicine on 6 October 2022, under reference number 2022-009. The study adheres to the principles outlined in the Declaration of Helsinki. Before involvement in the study, all participants will be required to provide written informed consent. To ensure the utmost confidentiality, data will be handled in an anonymous manner, with only participant codes stored in the central database. Personal information concerning potential and enrolled participants beyond the scope of this trial will not be gathered, shared or retained. The findings from this study will be disseminated through publication in a peer-reviewed journal and presentation at conferences.
Discussion
Stiff neck often causes pain for a period of time, and in severe cases even prevents patients from working and daily activities of living. Accordingly, rapid pain relief and return to normal movement are the main needs of ASN patients. The results of this study are expected to provide a simple and rapid-acting treatment for this condition.
Acupuncture has been widely used for the treatment of neck pain. Meta-analyses of RCTs collectively affirm its therapeutic potential and provide valid evidence for its clinical application. A recent meta-analysis indicated that electroacupuncture was more effective than other interventions (usual care, sham acupuncture or no treatment) in reducing pain and disability index scores.35 Similarly, several other reviews support acupuncture’s role in treating neck pain, highlighting its potential as a non-pharmacological treatment option.36 37 For the treatment of acute phase, prioritising simple and straightforward procedures is essential. Therefore, it is advisable to choose acupoints with significant effects when selecting an acupuncture prescription. According to the acupuncture theory, the distribution area of stiff neck is closely related to three meridians, including the sanjiao meridian of hand Shaoyang, the small intestine meridian of hand Taiyang, and the large intestine meridian of hand Yangming. Accordingly, the main pain relief acupoints located on these three meridians were selected, namely, LI10, SI3 and TE3.38 39 In addition, it is worth noting that the acupoints in this study were selected on the healthy side. This method of acupoint selection originates from traditional Chinese needle techniques. Records indicate that contralateral acupuncture is a unique method for pain relief in acupuncture therapy, and it continues to be practised to date.40 41 Moreover, modern studies have also proved that contralateral acupuncture can directly regulate the anterior cingulate cortex and other brain areas to play an analgesic role.42 Furthermore, acupuncture on the healthy side can be more conducive to the patient’s movement of the affected limb, and a study has suggested that contralateral acupuncture is more effective in reducing pain than ipsilateral acupuncture.42–44
Previous studies have demonstrated that acupuncture treatment for acute pain typically spans from 30 min to 1 hour, with significant relief of pain symptoms occurring approximately 10 min after treatment.18 45 46 To achieve optimal treatment outcomes within a shorter time frame and alleviate patient pain during the course of treatment, this study selected a 10 min intervention period to more effectively assess the immediate effects of acupuncture. Regarding the assessment criteria, we used the VAS score and ROM to promptly evaluate both pain and neck movement. The VAS score is characterised by accuracy, simplicity and high sensitivity and is widely used in both clinical practice and scientific research. ROM is a commonly used tool for assessing cervical ROM and can quickly assess cervical movements such as anteflexion, rear protraction, right and left lateral flexion, and rotation.
Choosing an appropriate control group is a crucial aspect of designing high-quality clinical studies. The active exercise group was selected as a control group based on several considerations. First, neck pain is caused by muscle spasm in the neck and shoulder region. Active exercise is also a commonly used treatment in neck pain and has a positive impact on pain relief and improved function.3 5 A previous randomised trial comparing spinal manipulation, home exercise and pharmacotherapy for acute and subacute neck pain found that after 26 weeks of treatment, the exercise group demonstrated superior outcomes compared with the medication group.47 A systematic evaluation, which included 27 RCTs, demonstrated that a structured exercise programme involving active exercises and strengthening exercises helped reduce pain and improve movement in patients with neck pain compared with control groups such as passive treatment, placebo and wait-list treatment.48 Another systematic review showed that exercise interventions, including active exercise, were more effective than no treatment, sham treatment or alternative interventions.49 These results suggest that active exercise has the potential to be an effective method to relieve pain and improve functional movement in patients with neck pain. Second, this group aims to evaluate the independent effect of active exercise as a baseline treatment for ASN. This will provide a benchmark against which the additional benefits of acupuncture combined with active exercise can be assessed. Third, by comparing the results of the sham acupuncture combined with active exercise group and the active exercise group, it is possible to distinguish between the specific analgesic effects of acupuncture and a placebo response. Blunt needling has been suggested as a more suitable sham control for acupuncture studies as it minimises physiological responses and is relatively inert.50 51 Accordingly, a blunt, non-penetrating needle was selected as the placebo needling device in this study allowing for better blinding. By comparing the three groups, we can comprehensively assess the combined treatment efficacy and potential treatment advantages while enhancing the study’s reliability and clinical relevance.
To the best of our knowledge, this study is the first high-quality RCT evaluating the efficacy of acupuncture combined with active exercise in rapidly relieving pain and improving movement in patients with ASN within 10 min. The results of this study will provide a simple and effective treatment strategy for ASN patients. However, this study also has several limitations. First, the acupuncturist will not be blinded to group allocation, potentially affecting the treatment’s efficacy as a result of the acupuncturist’s subjective awareness. However, to minimise bias associated with subjective measures, outcome assessors will be blinded. Second, this is a single-centre study and the findings can be further validated in multiple centres. Third, the study lacked a follow-up period, which will be addressed through additional follow-up in future studies.
In summary, rapid pain relief and improved movement are the main needs for ASN patients. Acupuncture combined with active exercise is an effective combination therapy, but there is a lack of high-quality research evidence to support it. The results of this study will provide a simple and rapid-acting treatment for ASN patients.
Ethics statements
Patient consent for publication
Acknowledgments
The authors would like to convey their genuine appreciation to all the patients who took part in the trial.
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