Clinical study on traditional Chinese medicine fumigation for improving shoulder joint function after ultrasound-guided hypertonic dextrose injection in patients with rotator cuff injury.

AIM: This study was aimed at exploring the efficacy and safety of traditional Chinese medicine (TCM) fumigation in improving shoulder joint function after ultrasound-guided hypertonic dextrose injection in patients with rotator cuff injury. METHODS: One hundred and eighty-four subjects with rotator cuff injury were randomized into two equal groups: an experimental group and a control group. The control group only received the ultrasound-guided hypertonic dextrose injection, while the experimental group received TCM fumigation treatment following the injection. The two groups were compared for their Constant-Murley Shoulder (CMS) score, Modified University of California at Los Angeles Shoulder Rating Scale (Modified UCLA) score, Visual Analog Scale (VAS) scores and safety before enrollment as well as 2 and 6 months after the completion of the treatment course. The clinical efficacy of the treatment was evaluated 6 months after the end of the course. RESULTS: The pretreatment scores of the two groups did not show any statistically significant differences. However, at the end of the 2 months of the treatment, the experimental group showed higher CMS scores [Mean Difference (MD) = 6.83, 95% CI (4.18, 9.48), Cohen's d = 0.75, t = 5.09, P < 0.001]; lower VAS scores [Median Difference (MD) = -0.70, 95% CI (-1.00, -0.30), r = 0.29, Z = -3.92, P < 0.001]; and higher modified UCLA scores [MD = 2.07, 95% CI (0.75, 3.40), Cohen's d = 0.46, t = 3.09, P = 0.002], than the control group. At the end of 6 months of the treatment, no statistically significant differences were noted in the scores in the two groups. There were no statistically significant differences in the rates of marked effect and total rate of effectiveness [Rate Difference (RD) = 0.04, 95% CI (-0.09, 0.18), ϕ = 0.05, χ2 = 0.39, P = 0.533], and [RD = 0.01, 95% CI (-0.10, 0.12), ϕ = 0.01, χ2 = 0.04, P = 0.848]. The two groups did not show any significant difference with respect to safety in terms of the frequency of adverse events. CONCLUSION: Compared with ultrasound-guided hypertonic dextrose injection alone, a combined treatment plan where the injection is followed by TCM fumigation can significantly improve the shoulder joint function and reduce the pain score of subjects in the short term, with good safety. However, there were no significant differences in the long-term efficacy of the two methods. CLINICAL TRIALS REGISTRATION: (http://www.chictr.org.cn), identifier [ChiCTR2100050251].