The effectiveness and safety of thread-embedding acupuncture for chronic rotator cuff disease: A study protocol for a randomized, patient-assessor-blinded, controlled, clinical trial

Abstract Introduction This report provides a clinical study protocol designed to verify the effects and safety of thread-embedding acupuncture (TEA) for chronic rotator cuff disease with regard to pain relief, improvement of shoulder function, and quality of life. Methods/design This is a study protocol of a randomized patient-assessor-blinded, controlled, clinical trial. This study will be carried out at Kyung Hee University Hospital at Gangdong in Korea. Participants with shoulder pain lasting more than 3 months will be recruited to the study. After eligibility screening, a total of 64 participants will be randomly allocated to one of the 2 groups in this trial, with 32 participants in each group. Over the 8 weeks treatment period, TEA and sham TEA will be performed in the respective groups once a week. In the follow-up phase, participants will undergo a telephone interview after 12 weeks and will visit for a final evaluation after 16 weeks. Results The primary outcome measure is the change in pain intensity between baseline and treatment completion (8 weeks). Secondary outcome measures include the values for pain intensity, shoulder disability, safety, satisfaction, and quality of life. Conclusions Previous studies have shown that TEA could be an alternative treatment for shoulder pain. However, there is still a lack of scientific evidence regarding the effectiveness of TEA for chronic rotator cuff disease. This study will provide useful evidence regarding the effectiveness and safety of TEA treatment. The findings will serve as important data for conducting additional acupuncture studies on chronic rotator cuff disease.