Frozen shoulder, also known as periarthritis of shoulder, fifty shoulder, etc., is aseptic inflammation of soft tissue around shoulder joint caused by degenerative changes of shoulder joint, with shoulder pain and mobility disorders as the main symptoms, seriously affecting the quality of life. Frozen shoulder is more common in patients of 40-70 years old, and the prevalence rate is 2%-5%. At present, the pathogenesis of frozen shoulder is still not completely clear, and the main treatment purpose is to relieve pain and restore function. Currently, non-steroidal anti-inflammatory drugs are mainly used to relieve pain in clinical practice, but the efficacy is limited. Surgical release is effective in reducing adhesion and restoring joint activity, but it is easy to relapse and the cost is high. It is of great significance to find long-term effective, economical and convenient therapeutic drugs to improve patients’ life quality. Cheezheng Xiaotong Plaster is a traditional Tibetan medicine prescription, with the effect of promoting blood circulation, removing blood stasis, reducing swelling and relieving pain, which is widely used in acute and chronic torsion and contusion, stiff neck, periarthritis of shoulder, lumbar muscle strain and other diseases.

To compare the effect of Cheezheng Xiaotong Plaster and local drug injection in the treatment of frozen shoulder, and evaluate the advantages of Cheezheng Xiaotong Plaster in relieving pain of frozen shoulder patients and increasing the recovery of shoulder function.

A multicenter randomized controlled trial was developed, and a total of 280 subjects with frozen shoulder, from 8 domestic centers were divided into treatment group or control group with random digital table, 140 cases in each group. The treatment group was treated with Cheezheng Xiaotong Plaster of 1 post for 8 hours every day from the first week to the second week, and 1 post every other day from the third week to the fourth week. The control group was given sodium hyaluronate + 1% lidocaine 1 ml by subacromial injection once. The visual analogue scale (VAS) score of pain, Oxford shoulder function score (OSS) and shoulder range of motion of the two groups were recorded at the time of initial diagnosis, 14 days, 28 days and 90 days after treatment. In this study, the VAS score reduction rate after 28 days of medication was taken as the main efficacy index, and reduction rate > 30% was regarded as effective. Vital signs, laboratory data and adverse events were recorded.

The effective rate was 91.3% in the treatment group and 84.1% in the control group conforming to the protocol population set, with no significant difference between the two groups (P>0.05) . After 14 days of treatment, there was a significant difference in VAS score reduction rate between the two groups (P<0.01) , which was 70.5% and 42.7% respectively in the treatment group and the control group. The effective rates of the treatment group and the control group were 95.3% and 90.3%, respectively after 90 days of treatment (P>0.05) . After 14 days, 28 days and 90 days of treatment, OSS in the two groups declined, and decline in the treatment group was more significant (P<0.05) . Compared with the baseline period, the VAS scores of two groups both declined after 14 days, 28 days and 90 days of treatment, and the decline of the treatment group was more significant (P<0.01) . The range of motion of two groups both improved after 14 days, 28 days and 90 days of treatment. The improvement of abduction and external rotation in the treatment group was more significant (P< 0.05) .

Cheezheng Xiaotong Plaster has good curative effect on frozen shoulder, and its curative effect is not inferior to sodium hyaluronate + lidocaine injection. Cheezheng Xiaotong Plaster has significant effect in relieving pain and improving shoulder dysfunction, which could improve the range of motion of shoulder joint. Cheezheng Xiaotong Plaster are safe in clinical practice with no serious adverse events occurred.