Effectiveness of Tuina Therapy Combined With Yijinjing Exercise in the Treatment of Nonspecific Chronic Neck Pain

Key Points Question Is tuina combined with yijinjing more effective than tuina alone for nonspecific chronic neck pain? Findings In this randomized clinical trial of 102 individuals with nonspecific chronic neck pain, the combined therapy had a statistically significant advantage in reducing pain at week 8 compared with tuina therapy alone. The effectiveness was still present at 12-week follow-up. Meaning These findings suggest that a combination of tuina therapy and yijinjing exercise was more effective than tuina therapy alone in the treatment of patients with nonspecific chronic neck pain.


Introduction
Neck pain is a common musculoskeletal disorder with a high prevalence worldwide.It is the fourth most common cause of disability in the US.The mean lifetime prevalence of neck pain is 48.5% (range, 14.2%-71%), the third highest in the US after diabetes and heart disease. 1 Compared with low back pain, neck pain has not received enough attention. 2No specific pathology could explain the cause of neck pain (eg, nerve root compression).Patients with symptoms that persist for more than 3 months can be diagnosed as having nonspecific chronic neck pain (NCNP). 3In addition, NCNP is often associated with anatomical, psychological, social, and occupational factors.Anxiety and depression are also thought to be associated with higher levels of pain in patients with musculoskeletal pain. 4cause NCNP often occurs without any established pathologic process and cause, it is difficult to adopt precise treatment methods.Therefore, drugs, intra-articular injections, and surgery are often used as common treatments.However, the efficacy of these treatments is not guaranteed. 5,6erefore, nondrug therapy has attracted more attention. 7Exercise is considered a treatment modality for pain relief.A previous systematic review found that multiple forms of exercise are beneficial to neck pain and disability. 8Complementary and alternative medicine, such as manual therapy, osteopathic therapy, and Qigong, have been used widely in treating NCNP. 9,10ina is a Chinese manual therapy that consists of 2 passive treatments.One is soft tissue manipulation, which consists of manual techniques, such as pressing, pushing, and kneading.The other is spinal manipulation, including high-velocity, low-amplitude thrust procedures or low-velocity, variable-amplitude mobilization. 11Systematic reviews have reported that tuina therapy can alleviate pain and relax stiff soft tissue for patients with NCNP. 12,13However, research on the direct physiologic mechanisms of tuina therapy for neck pain is relatively limited.Two previous basic studies on animal experiments showed that pain behavior of mice was improved after simulating massage manipulation, which was associated with reduced peripheral inflammation mediated by the mechanosensitive channel protein Piezo and senescence-related pathways. 14,15A recent study simulated the treatment process of tuina manipulation and found that the analgesic effect on a neuropathic pain model may be related to the inflammatory pathway regulated by noncoding RNA. 16jinjing is a type of traditional Chinese exercise that puts emphasis on the coordination of posture, meditation, and breathing.It is a moderately intense mind-body exercise that is easy to practice with few limitations. 17The results of a systematic study showed that physical and mental exercises, including yijinjing, are beneficial for the recovery of neck pain and disability. 18Two recent studies on the neuroimaging of patients with stroke after a yijinjing intervention reported that it can modulate brain neural network connections, which may be a central mechanism of its analgesia. 18,19though tuina and yijinjing have been widely used in clinical treatment of NCNP in China, few high-level randomized clinical trials have been performed because of the limitations of traditional Chinese medicine research methods.In addition, nondrug therapy integrated into pain management is recommended by a clinical practice guideline. 20Thus, a 12-week, open-label, analyst-blinded randomized clinical trial was conducted to assess the effectiveness of tuina combined with yijinjing in treating NCNP.The results were measured by the patient-reported outcome visual analog scale (VAS) scores after the 8-week intervention.We hypothesized that tuina combined with yijinjing would play a better role in improving pain, disability, and anxiety.

Study Design
Full details of the trial have been published. 21 The study was performed in accordance with the principles of the Declaration of Helsinki 22 and approved by the Regional Ethics Review Committee of Yueyang Hospital.The reporting of the study complies with the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.The trial protocol can be found in Supplement 1.

Eligibility Criteria
Participants with confirmed NCNP were eligible for the present study.Inclusion criteria were as follows: men or women aged 20 to 50 years whose VAS scores were 3 or higher and Neck Disability Index scores were 10 or higher, with chronic neck pain persisting for at least 3 months, with no history of shoulder and neck surgery, and with negative results on the neck distraction test, Spurling neck compression test, and Adson test.Exclusion criteria were as follows: specific disorders of the cervical spine, such as cervical radiculopathy or myelopathy; history of whiplash injury and/or head or neck injuries; being pregnant or lactating; neck pain radiating into the upper limb; history of severe trauma or tumor; having received clinical treatment for neck pain in the past 3 months; being unable to speak or write Chinese; adverse reactions to tuina and yijinjing; undergoing tuina or yijinjing in the past 3 months; and poor cooperation.

Randomization, Allocation Concealment, and Blinding
After recruitment and baseline measurements, an independent office employee at the department generated the randomization list by a random-number generator (Strategic Applications Software, version 9.1.3;SAS Institute Inc).The randomization database was prepared at the same time.The random numbers were placed in sealed envelopes that had been numbered in order.The therapist opened envelopes sequentially in front of the patients and allocated the patients to the 2 groups in a 1:1 ratio randomly.
Except for the tuina therapist and yijinjing teacher, other researchers, including statisticians, outcome assessors, and data analysts, were blinded to group assignments.The tuina therapist and yijinjing teacher were not involved in the outcome assessment or data analysis.

Interventions
Patients in both the tuina group and the tuina combined with yijinjing group received a total of 24 tuina treatment sessions (3 sessions per week for 8 consecutive weeks).Tuina was performed by a senior therapist who held a Traditional Chinese Medicine Practitioner Qualification License for more than 10 years.The intensity level of tuina was based on a physical examination and the therapist's clinical experience after careful communication with each participant.A 3-step protocol, including soft tissue manipulation, clicking acupoint manipulation, and spinal manipulation, was performed by the tuina therapist to alleviate neck pain and restore neck function by relaxing the soft tissue of the neck and shoulder (eAppendix 1 in Supplement 2).
For patients in the tuina combined with yijinjing group, in addition to the 24 tuina sessions, a 5-step protocol of yijinjing was applied to improve the therapeutic effects.The 5 movements included the Third Aspect of Wei-tuo, taking away a star and changing the dipper for it, nine demons drawing their swords, bowing in salutation, and wagging the tail (eAppendix 2 in Supplement 2).
Yijinjing was taught by a yijinjing teacher with 10 years of teaching experience.Yijinjing was practiced by the patients for 24 treatment sessions (3 sessions per week for 8 consecutive weeks).Each week, participants practiced yijinjing with the teacher once, then practiced it twice by themselves at home.
A digital video disk about the movements was given to patients to review the movements in detail.
The participants were required to upload videos and photographs of their own practices to the researchers.The videos and photographs were carefully examined by the yijinjing teacher.Some advice was given to the participants to help them practice yijinjing more effectively.All details about the intervention are shown in eAppendixes 1 and 2 in Supplement 2.
The tuina therapist and yijinjing teacher were trained for a week.They had passed a test to ensure consistency of study methods before participating in the trial.

Outcomes
The primary outcome was the change in VAS score at the end of the intervention (week 8). 23,24The secondary outcomes included Neck Disability Index score, which provided a subjective assessment of patients' function disability, consisting of 10 dimensions, such as pain and living standard. 25The Self-rating Anxiety Scale was used to assess anxiety level. 26The Chinese versions of the scales are all questionnaires that have obtained sufficient evidence of reliability and validity.Tissue hardness was measured by a digital algometer.The measuring point is placed between the C7 vertebra and the acromion at the middle point of the upper trapezius muscle.The active range of motion (AROM) was assessed with an electronic spine measuring device.Normal AROM of the neck was 30°to 45°flexion and extension, 30°to 45°left and right lateral flexion, and 60°to 80°left and right rotation.The measuring method is shown in eAppendix 1 in Supplement 2.
These outcomes were measured by blinded researchers.To avoid disclosing group assignments during the trial, patients were allowed only minimal conversation beyond what was necessary to measure the results at each measurement point.The researchers who used the digital algometer and the electronic spine measuring device participated in the 1-week training to understand how to use the instruments and passed relevant tests before participating in the trial.They were taught how to communicate with patients to avoid unnecessary conversation during the evaluation.We also collected outcome data at 12 weeks as an exploratory end point.

Statistical Analysis
The sample size calculation was based on a previous study (n = 78) performed in 2016, 27 which showed that the mean (SD) VAS scores were 5.5 (1.1) in the tuina group and 4.7 (1.3) in the tuina combined with yijinjing group after an 8-week intervention.Under the assumption that the superior effect was 1.3 of the difference in VAS score, with α = .05and β = 0.1, the sample size was determined to be 84 patients (42 per group).With an assumed 20% dropout rate, 102 patients were recruited into this trial.
Data were analyzed from December 10 to March 26, 2022.Data analysis was based on the intention-to-treat principle.Descriptive analysis was used for the baseline characteristics of the patients in each group.All numerical data are presented as mean (SD).For quantitative data that did not conform to a normal distribution, data are expressed as median (IQR).In all analyses, statistical significance was accepted as a 2-tailed P < .05.For the primary outcome, VAS scores were assessed by using the linear mixed-effects model with the interaction effects of time and group.Participants who did not complete the study were treated as having no change from baseline at all times.A Bonferroni correction was used to account for multiple comparisons.Correlation analysis was conducted between the difference of the tissue hardness and the other outcome measures by the Pearson correlation analysis.All statistical analyses were conducted with SPSS software, version 24.0 (SPSS Inc).

Efficacy
Table 2 gives the VAS scores of the 2 study groups; the results were analyzed to reveal changes from baseline (week 0) to 12-week follow-up (week 12).At the 8-week posttreatment assessment (primary end point), the tuina group had a mean reduction of −4.1 (95% CI, −4.4 to −3.8), and the tuina combined with yijinjing group had a mean reduction of −5.4 (95% CI, −5.8 to −5.1) in the VAS score from baseline.The tuina combined with yijinjing group showed a significant between-group difference in VAS score of −1.2 (95% CI, −1.6 to −0.8; P < .001)compared with the tuina group after the 8-week intervention period.A comparison of the VAS scores in the 2 groups is shown in Figure 2.
The secondary outcomes are given in Table 3.In the time point analysis, at the primary end point of week 8, compared with the tuina group, the tuina combined with yijinjing group showed significantly superior effectiveness for all secondary outcomes (function, −4.5 [95% CI, −5. 5       more clinically meaningful and should be collected and analyzed in future studies.Seventh, no control group was used because tuina therapy is considered experimental, and whether yijinjing exercise alone has a good effect on NCNP needs to be verified in future studies.

Conclusions
In this randomized clinical trial, patients with NCNP who received tuina combined with yijinjing showed greater improvement in terms of pain intensity, disability, and anxiety than those who underwent tuina therapy.Tuina combined with yijinjing can be recommended for routine use as supplemental therapy for pain control in patients with NCNP.
A single-center, open-label, assessor-blinded randomized clinical trial was performed from September 7, 2020, to November 23, 2021, at Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated with Shanghai University of Traditional Chinese Medicine.All participants were recruited mainly through online social JAMA Network Open | Complementary and Alternative Medicine Tuina Therapy Plus Yijinjing Exercise in Treatment of Nonspecific Chronic Neck Pain platforms, advertisements, and hospital posters.All participants provided written informed consent.
Correlation analysis was conducted for the difference of the tissue hardness of the left and right upper trapezius muscle and the difference of scales and AROM before (week 0) and after intervention (week 8) in the tuina combined with yijinjing group.The difference in the tissue hardness of the left upper trapezius muscle was negatively correlated with the difference in flexion (r = −0.378;P = .006)and right rotation (r = −0.456;P = .001).The difference in the tissue hardness of left upper trapezius muscle was positively correlated with the difference in the tissue hardness of right upper trapezius muscle (r = 0.574; P < .001).The difference in the tissue hardness of the right upper trapezius muscle was negatively correlated with the difference in flexion (r = −0.517;P < .001)and right rotation (r = −0.497;P < .001).All outcomes are shown in eAppendix 3 in Supplement 2.

Figure 2 .
Figure 2. Changes in Outcomes Among Groups Over Time

Table 1 .
Baseline Characteristics of the Intention-to-Treat Population a At the 12-week follow-up, the tuina combined with yijinjing group continued to show superior effectiveness for the treatment of NCNP (VAS score, −1.6 [95% CI, −2.0 to −1.2]; NDI score, −4.9 [95% CI, −6.0 to −3.8]; Self-rating Anxiety Scale score, −8.1 [95% CI, −9.8 to −6.4]; tissue hardness, −4.1 [95% CI, -5.0 to −3.2] on the left and -2.5 [95% CI, −4.2 to −3.4] on the right; and active range of Abbreviations: NDI, Neck Disability Index; SAS, Selfrating Anxiety Scale; VAS, visual analog scale.aData are presented as number (percentage) of participants unless otherwise indicated.No differences were found between groups for any characteristics at baseline.bOn the VAS, higher scores indicate worse pain.cScores range from 0 to 50, with higher scores indicating worse disability.dScores range from 20 to 80, with higher scores indicating worse anxiety.eMeasured by a digital algometer.fMeasured by electronic spine measuring device.

Table 2 .
VAS Scores Among Study Participants a On the VAS, higher scores indicate worse pain.b Compared using Bonferroni correction.
a Calculated by using Bonferroni correction.b Scores range from 0 to 50, with higher scores indicating worse disability.c Scores range from 20 to 80, with higher scores indicating worse anxiety.d Measured by digital algometer.e Measured by electronic spine measuring device.