慢性腱板疾患に対するスレッド埋没鍼治療の有効性、安全性、費用対効果：無作為化、患者評価者盲検、対照、臨床試験
Yeon-Cheol Park1,2, Sangyeup Chae3, Yeonhak Kim4
1Department of Acupuncture and Moxibustion, Kyung Hee University College of Korean Medicine, Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea.
Background:
Chronic rotator cuff disease (RCD) is a growing cause of persistent shoulder pain and disability. Although acupuncture is commonly used, sustained benefits remain uncertain. Thread-embedding acupuncture (TEA) provides prolonged stimulation, but evidence for chronic RCD is limited; thus, we evaluated its effectiveness, safety, and cost-effectiveness versus sham TEA.
Methods:
Patients with chronic rotator cuff disease were included. The treatments were divided into 2 groups once a week for 8 weeks. The control group received sham TEA, which was different from that administered to the experimental group. In other words, a randomized, patient-assessor-blinded, controlled, clinical trial was conducted. The effects of TEA were evaluated based on indicators related to pain reduction (100-mm visual analog scale), shoulder function improvement (shoulder pain and disability index, range of motion [ROM] of the shoulder), and quality of life (rotator cuff quality of life score and EuroQol 5-dimension 5 levels). Additional follow-up visits were conducted via telephone at 12 and 16 weeks of age.
Results:
The results showed pain relief and functional improvement within each group; however, no statistical significance was observed between each group. However, the ROM of the external rotation (ER) side was statistically significant in the experimental groups, as compared to the control group (P < .05). Adverse events that could be considered as safety issues have not been reported. In the cost-effectiveness evaluation, TEA treatment was found to be more economical, depending on the indices (i.e., some ROM indices and rotator cuff quality of life score) and the socially agreed willingness to pay based on those indices.
Conclusion:
The TEA treatment resulted in partial clinical improvements, including pain relief and shoulder function; however, these results were not statistically significant. Nevertheless, the TEA treatment was statistically significant in clinical improvement and cost-effectiveness for the range of external rotations.
