Effectiveness and safety of fluoroscopy-guided acupuncture for subacromial impingement syndrome: A protocol for a randomized, patient-assessor blind, parallel clinical trial

INTRODUCTION: Subacromial impingement syndrome (SIS) is one of the most common diseases inducing shoulder pain. Acupuncture is a source of pain relief that has been used for SIS; however, there is no clinical study about image-guided acupuncture for SIS. The aim of this study is to evaluate the effectiveness and safety of fluoroscopy-guided acupuncture in patients with SIS. METHODS: This is the protocol for a randomized, patient-assessor blind, parallel clinical trial comparing fluoroscopy-guided acupuncture to acupuncture without fluoroscopy. There will be a 1-week run-in period before random allocation to 2 groups. The total duration of the clinical trial will be 3 weeks including 2 weeks for the follow-up period. A total of 57 participants will be enrolled for the clinical trial. Acupuncture will be conducted in 2 sessions for each group, once at baseline and once at the 1-week mark. The primary outcome will be 100 mm pain visual analogue scale. Secondary outcomes will include the Neer and Hawkins test, the Modified Constant Murley Score scale, the Shoulder Pain And Disability Index, the patient satisfaction degree, and the accuracy rate of acupuncture. For the evaluation of safety, adverse events will be monitored. DISCUSSION: We designed the clinical trial using image-guided acupuncture. This will be the first trial to study the effectiveness of image-guided acupuncture for SIS compared with acupuncture using the proportional measurements. TRIAL REGISTRATION: Clinical Research Information Service Registration Number is KCT0002751. Registered on March 23, 2018.