Efficacy and safety of Shi's cervical manipulation versus diclofenac for patients with acute and subacute neck pain: a multicenter clinical randomized trial.

OBJECTIVE

To confirm the effectiveness and safety of Shi's manipulation in treating acute and subacute neck pain patients.

METHODS

This multicenter, positive controlled, randomized clinical trial has trial and control groups. There were 240 patients randomly assigned to the trial group and the control group, and both groups received their respective intervention treatment methods for a period of 12 weeks. The time windows for clinical data collection were before treatment, immediately after treatment, 3-d 1, 2, 4, 8, and 12 -week after treatment, and follow-up was conducted at 26 and 52-week after treatment. The observed indicators used include primary outcome index and secondary outcome index, with the primary outcome index being the assessment of neck pain severity, which is evaluated by patients using Numerical Rating Scale (NRS). Secondary secondary outcome index include, (a) cervical dysfunction index, measured by patients using the Neck Disability Index (NDI) for self-assessment; (b) Cervical activity measurement, measured through the cervical range of motion measurement program on Android mobile system; (c) Satisfaction treatment assessment, determined by the patient's self-evaluation; (d) Safety index, recorded the incidence of adverse reactions and adverse event.

RESULTS

The results showed that these efficacy indices were improved in different degrees in both groups. At immediate after intervention, there was significant difference in NRS, NDI, Cervical Range of Motion (ROM) between the two groups (P < 0.01), the trial group was superior to the control group. At 3-d after intervention, there was significant difference in NRS, NDI, ROM between the two groups (P < 0.01). At 1-week and 2-week after intervention, there was significant difference in NDI and ROM between the two groups (P < 0.01). At 4-week and 6-week after intervention, there was significant difference in NDI, ROM between the two groups (P < 0.05). At 8-week after intervention, there was significant difference in NDI, lateral-bending and axial-rotation ROM between the two groups (P < 0.05). At 12-week after intervention, there was significant difference in NDI between the two groups (P < 0.01). At 26-week and 52-week after intervention, there was significant difference in NDI, NRS between the two groups (P < 0.01). In addition, the adverse reaction of trial group is significantly lower than that of control group (P < 0.05). The satisfaction of patients in the trial group was better than that in the control group (P < 0.01).

CONCLUSION

Our findings suggest that Shi's manipulation can be a good complementary treatment option in patients with acute and subacute neck pain.