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

Background: Subacromial impingement syndrome (SIS) is one of the most common causes of shoulder pain, and acupuncture treatment is widely used as treatment. However, no studies have examined image-guided acupuncture for SIS. This study evaluated the effectiveness and safety of low-dose X-ray guided acupuncture (LA) in patients with SIS. Methods: A total of 54 patients with SIS were randomly allocated to the LA group and the conventional acupuncture (CA) group. Two acupuncture treatment sessions were conducted for a week, and follow up was conducted after three weeks. The primary outcome was pain intensity measured by the visual analogue scale (VAS) during the Neer and Hawkins test. The incidence rate of shoulder impingement sign, the modified Constant-Murley score (CMS) and the Shoulder Pain and Disability Index (SPADI) were assessed as other outcomes. All indicators were assessed at baseline and after one week and three weeks. For safety evaluation, adverse events were monitored in both groups. Results: The change in pain during the Neer test after one week from baseline was more significant in the LA group than in the CA group (p=0.008). However, the Hawkins test did not show a difference between the two groups. The incidence rate of shoulder impingement sign and the changes in CMS and SPADI were not significantly different between the two groups at one week, but after three weeks, SPADI was more significantly improved in the LA group (p=0.024). No adverse events were related to this trial. Conclusion: LA was more effective than CA in relieving pain and improving function in terms of VAS and SPADI. Trial registration: This study was registered at the Clinical Research Information Service: KCT0002751