|Year : 2016 | Volume
| Issue : 1 | Page : 31-37
Safety and efficacy of WeChat combined with Yi Jin Jing exercise for the treatment of cervical spondylosis in white-collar workers: study protocol for a prospective open label randomized controlled trial
Guang-hui An1, Xiao-ting Tang M.D. 2, Guo-miao Zhu3
1 Shanghai University of Traditional Chinese Medicine, Shanghai, China
2 Shanghai University of Traditional Chinese Medicine, Shanghai; Wanggang Community Health Center of Shanghai Pudong New Area, Shanghai, China
3 Shanghai University of Traditional Chinese Medicine, Shanghai; Shanghai Spinecare Physical Theary and Exercise Rehabilitation Center, Shanghai, China
|Date of Web Publication||16-Mar-2016|
Shanghai University of Traditional Chinese Medicine, Shanghai; Wanggang Community Health Center of Shanghai Pudong New Area, Shanghai
Source of Support: None, Conflict of Interest: None
Background: Yi Jin Jing (changing tendon exercise) is a traditional Chinese exercise. Yi Jin Jing can reportedly prevent cervical spondylosis in financial professionals. In the absence of effective supervision and follow-up training, Yi Jin Jing self-exercise does not become habitual, reducing the efficacy of the technique. WeChat is an online text and voice messaging communication service developed by Tencent in China, and can be used as an interactive platform for doctors and patients. We hypothesized that WeChat could be used to guide Yi Jin Jing exercise, potentially enhancing the preventative and therapeutic benefits for cervical spondylosis in white-collar workers.
Methods/Design: 120 financial professionals with cervical spondylosis working at the Bank Card Industrial Park in Pudong New Area, Shanghai, China will be enrolled in this prospective, open label, randomized controlled trial. Participants will be equally and randomly divided into two groups. In the intervention group, participants will undertake conventional Yi Jin Jing training followed by a group chat using WeChat to provide interactive guidance. In the control group, participants will undertake conventional Yi Jin Jing training alone. The primary ontcome will be the Cervical Spondylosis Symptoms scale measured 1, 3, 6 and 12 months after training. The secondary outcomes will be the 36-item Short Form Health Survey score, Visual Analog Scale score for pain intensity, medical expenses and the number of days absent from work.
Discussion: This study will examine whether on-going interactive Yi Jin Jing exercise using the WeChat platform will improve outcomes in participants with cervical spondylosis.
Trial registration: This trial was registered with the Chinese Clinical Trial Registry (identifier: ChiCTR-OCH-13003426) on 6 August 2013.
Ethical approval: Written approval for this project was obtained from the Ethics Committee of Wanggang Community Health Center, Shanghai Pudong New Area, Shanghai, China (approval number WG2013 0709001). All patients will be informed of the protocols and will provide written informed consent.
Keywords: clinical trial; cervical spondylosis; WeChat; Yi Jin Jing; white-collar workers; validity; safety
|How to cite this article:|
An Gh, Tang Xt, Zhu Gm. Safety and efficacy of WeChat combined with Yi Jin Jing exercise for the treatment of cervical spondylosis in white-collar workers: study protocol for a prospective open label randomized controlled trial. Clin Trials Orthop Disord 2016;1:31-7
|How to cite this URL:|
An Gh, Tang Xt, Zhu Gm. Safety and efficacy of WeChat combined with Yi Jin Jing exercise for the treatment of cervical spondylosis in white-collar workers: study protocol for a prospective open label randomized controlled trial. Clin Trials Orthop Disord [serial online] 2016 [cited 2019 Apr 19];1:31-7. Available from: http://www.clinicalto.com/text.asp?2016/1/1/31/178853
| Background|| |
Cervical spondylosis is a degenerative disorder characterized by cervical hyperostosis, cervical intervertebral disc degeneration and protrusion, hypertrophy of the ligamentum flavum and ossification of the posterior longitudinal ligament that may cause cervical spondylotic myelopathy (Li et al., 2007; Zhang et al., 2010; Zhou, 2010; Cai and Wang, 2011; Fang et al., 2015; Tian and Zhang, 2015). Financial professionals are at high risk of cervical spondylosis. Age, time spent working at a desk, work posture, mood and office ventilation are reportedly risk factors for cervical spondylosis, which in turn may greatly impair the quality of work and quality of life of financial professionals (Hartzell et al., 2014; Samartzis et al., 2005).
In traditional Chinese medicine, it is believed that tendons can generate the power needed to stretch limbs. For example, the skeletal muscle, tendons, ligaments and sarcolemma attached to the skeletal tissue strongly influence movement. Furthermore, neck tendon disease affects the stability of the cervical spine, impairs neck movement and is an important factor in the pathogenesis of cervical spondylosis (Xie et al., 2014).
Yi Jin Jing (changing tendon exercise) is a traditional Chinese training method comprising 12 routines (Shao et al., 2012). Yi Jin Jing focuses on physical fitness and emotional wellbeing, and reportedly strengthens bones and organs by means of its unique combination of flexion, extension and rotation exercises and abdominal breathing, stretching tendons and realigning bone, at the same time preventing disease and increasing lifespan (Zhang et al., 2015). Dou et al. (2014) reported that the "Tuotianzhuang" of Yi Jin Jing could markedly induce an infrared radiation trajectory along the DU meridian on the back, and increase temperature on the Dazhui (DU 14), DU meridian and neck areas. White-collar workers in the financial industry at high risk of cervical spondylosis are likely unable to find the time to undertake Yi Jin Jing exercise regularly. The best means of managing, guiding, monitoring and maintaining Yi Jin Jing exercise has not been established. WeChat, one of the largest standalone online messaging apps, could offer a solution to this problem.
We hypothesized that WeChat could be used to guide, manage and monitor Yi Jin Jing exercise, and to improve outcomes for patients with cervical spondylosis. We have designed a prospective, open, randomized controlled trial to test this hypothesis.
| Methods/Design|| |
This will be a prospective, open label, randomized controlled trial.
We aim to recruit 120 financial professionals with cervical spondylosis working at the Bank Card Industrial Park in Pudong New Area, Shanghai, China using online advertising.
- Aged 18-60 years
- Meet the diagnostic criteria of The Second National Symposium on Cervical Spondylosis in 1992 (Su, 1993)
- Chief complaint of neck pain; > 3 points on Visual Analogue Scale (VAS) score (Ciprandi et al., 2013)
- Neck pain and stiffness within nearly 3 months or more, and once a month averagely
- Have imaging evidence of cervical spondylosis on anteroposterior and lateral X-ray films, and/or evidence of cervical degeneration or cervical disc herniation on magnetic resonance or computed tomography images
- Irrespective of gender
- Provide written informed consent
- Patients with cervical spondylotic myelopathy
- Poorly controlled diabetes mellitus, unstable cardiovascular disease or cancer
- Not suitable to participate in this trial because of any reason
- History of neck trauma, fracture or surgery, neurological impairment (myasthenia gravis or abnormal spinal reflex), congenital vertebral anomalies, systemic bone or joint disease
- Pregnant or lactating women
- Acupuncture therapy for cervical spondylosis in the previous 3 months
- Using drugs or other non-drug treatment for cervical spondylosis
- Does not meet the inclusion criteria, but is mistakenly included
- Does not receive appropriate intervention despite meeting the inclusion criteria
- Voluntary withdrawal during the trial or withdrawal by the investigators
- Failure to complete the required intervention program
- Serious adverse reactions, complications or unexpected pathophysiological changes; or if continuation of the trial is judged to be harmful to the participants.
One hundred and twenty subjects will be randomly assigned a number using a random number table. The starting point of sampling and the sampling sequence will be arbitrary. Participants will be assigned to one of two groups in equal numbers. The 60 participants allocated to the intervention group will receive conventional Yi Jin Jing training, with subsequent guidance on the WeChat platform. The remaining 60 participants in the control group will receive conventional Yi Jin Jing training alone.
A Yi Jin Jing training manual written with reference to the Health Education Manual for Cervical Spondylosis (Li, 2011) will be given to participants on enrollment, so that all should have a good understanding of the pathophysiology of cervical spondylosis. Reinforcement, education and guidance will be given for 2 hours once a week for 4 weeks. The Yi Jin Jing routines are listed in [Table 1].
A researcher will start a group chat on WeChat and act as its owner and moderator. The 60 participants in the intervention group will be invited to this group chat. The owner will provide the group with conventional Yi Jin Jing training by video, and release the file to the group for future reference once the training is complete. All Yi Jin Jing training will be given by video.
The group moderator will regularly leave a voice message to remind each member to undertake their exercises according to the video. Members who have finished their exercises will give feedback to provide evidence of regular exercise. Interaction between doctors and participants will be encouraged to share training experience and address any difficulties that participants encounter.
Outcomes will be measured 1, 3, 6 and 12 months after training has been completed. Participants and investigators will be aware of randomization status and study protocol [Figure 1].
The primary outcomes will be scored on the Cervical Spondylosis Symptoms 20-point scale (Jiang and Shi, 1998), which includes assessments of symptoms (9 points), work and life skills (3 points) and physical signs (8 points).
The secondary outcomes are: (1) the 36-Item Short Form Health Survey score, SF-36 (Laucis et al., 2015) used to evaluate health-related quality of life in both groups; (2) a bisual Analog Scale for neck pain intensity at rest or during activity; (3) medical expenses of the cost of other treatments for cervical spondylosis sought by participants after Yi Jin Jing training; (4) number of days absent from work. The timings of outcome evaluations are shown in [Table 2].
Investigators will assess the severity of any adverse events (AEs). Tolerable neck pain after training will be considered a mild AE (acceptable), neck pain after training that interferes with daily life will be considered a moderate AE (interference), neck pain after training that requires time off daily work or activities will be considered a severe AE (unacceptable).
The following judgment standards will be used to assess AEs: (1) certainly related, the reaction appears consistent with the known type of reaction; (2) possibly unrelated, the reaction is not totally consistent with the known type of reaction; (3) unrelated, the reaction is not consistent with the known type of reaction; (4) cannot be assessed, the reaction is similar to the known type of reaction.
Data collection, management and analysis
Data will be collected on a case observation form and stored after assessment by a designated investigator. Data will be entered in a timely, accurate, complete and normative fashion. When a participant drops out or has poor compliance, the reasons will be given in the case observation form. An investigator will contact the participant to explore the reasons for their difficulty complying with the protocol, in an attempt to finish the evaluation, complete the follow-up record form and record the timing of the last episode of therapy. An electronic version of the data will be retained by a physician in the Department of Massage, Shanghai Shuguang Hospital, China.
To ensure the accuracy of the data, an electronic version of the data will be populated and managed by the Basic Department of Massage, College of Acupuncture and Massage, Shanghai University of Traditional Chinese Medicine, China. Numeric data will be input and checked twice. Adverse events will be input once and checked manually. After collection, data will be stored in computer database by a designated investigator. Files will be password protected and backup copies made.
Statistical analysis will be conducted by Anhui University of Chinese Medicine, China (Jingding Data Analysis Co., Ltd., China) using SPSS 13.0 software (SPSS, Chicago, IL, USA). The distribution of data will be ascertained: normally distributed data will be expressed as the mean, standard deviation (SD), minimum value (min) and maximum value (max); non-normally distributed data will be expressed as the lower quartile (q1), median and upper quartile (q3). Numeration data will be expressed as their constituent ratio.
The baseline data of both groups will be analyzed using the Mann-Whitney U non-parametric test and the chi-square test. The total dropout rate of both groups and the rate of AE-induced dropout will be compared between the groups using the chi-square test. The score on the 20-point Cervical Spondylosis Symptoms scale, medical expenses and the number of days absent from woirk will be compared between the groups using the Wilcoxon rank sum test. The VAS for pain and the SF-36 score will be compared using the Mann-Whitney U test. Relative risk and 95% confidence intervals will be used to indicate the severity of cervical spondylosis in both groups. All statistical tests will be two-sided, and a P value < 0.05 will be considered statistically significant.
| Discussion|| |
We aim to conduct a prospective, open label, randomized controlled trial to examine the safety and efficacy of WeChat in the application of Yi Jin Jing to financial professionals with cervical spondylosis.
We will select subjects for the intervention and control groups with similar demographic and clinical characteristics to minimize bias from potential confounding factors. This trial is designed to verify the objective effects of an online doctor-patient communication platform for disease prevention, provide objective evidence of a novel intervention for cervical spondylosis and broaden the evidence base for the use of traditional Chinese medicine in the prevention and treatment of chronic musculoskeletal disease. 
Data analysis ongoing at the time of submission.
Xiao-ting Tang's pre-test data showed that Yi Jin Jing training had significant benefits in the prevention of cervical spondylosis, and reduced the loss of social and economic benefits induced by cervical spondylosis in financial professionals. Yi Jin Jing is a traditional Chinese technique, substantially different from current forms of exercise-based therapies. Martial arts novels, television programs and films have increased public understanding and acceptance of the technique. A previous investigation showed that half of financial professionals we aware of Yi Jin Jing, 10% understood its action and effect, but only 1% financial professionals did Yi Jin Jing exercises. This increased after several promotional lectures, but at 6-month follow-up, only 2% continued to exercise. Questionnaire feedback suggests that self-training lacks effective supervision, motivation and follow-up training, so Yi Jin Jing does not become habitual. These problems diminish the therapeutic benefit of Yi Jin Jing exercise.
Conflicts of interest
XTT and GHA conceived and designed the trial protocol, wrote and revised the paper, and approved the final version for publication.
This paper was screened twice using CrossCheck to verify originality before publication.
This paper was double-blinded and stringently reivewed by international expert reviewers.
Funding: This study was supported by grants from the Scientific Research Program of Health-Care Qigong Management Center of General Administration of Sport of China, No. QG2015039; the Moral Education Innovation Project of Shanghai University of Traditional Chinese Medicine in China, No. DYYB201503; the Thirteenth Key Project of Course Construction of Shanghai University of Traditional Chinese Medicine in China, No. A1-20140136; the Disciplinary Talents of Traditional Chinese Medicine of Shanghai Pudong New Area of China, No. PDZYXK-5-2014032.
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[Table 1], [Table 2]