The synergistic effects of applying pulsed radiofrequency lesioning of the suprascapular nerve plus physical therapy on pain and function in patients with adhesive capsulitis: A protocol of a prospective, randomized, controlled trial

BACKGROUND: To our knowledge, there have been no published clinical trials to assess the synergistic effects of applying pulsed radiofrequency (PRF) stimulation of the suprascapular nerve (SSN) plus physical therapy on pain and function in patients with adhesive capsulitis. Therefore, we will conduct this present randomized, double-blind study to evaluate the synergistic effects of applying PRF stimulation of the SSN plus physical therapy on pain and function in patients with adhesive capsulitis. METHODS: The study protocol is a randomized, controlled, double-blind design. Recruitment will be started in March 2021 and completed in October 2022. The treating surgeon will assess 90 patients for eligibility. The study protocol was approved through Institutional Review Board in the People's Hospital of Beilun district of Ningbo. Each patient will be randomized into 3 treatment groups, receiving PRF stimulation of the SSN or physical therapy or both of them. After baseline examination, all patients will be given a full explanation of the treatment protocol and will be required to sign a written informed consent for study participation and for publication of the results. All the data collectors, surgeons, statistical analysts, as well as result assessors are not aware of grouping assignment. The outcomes include Constant score, visual analog scale score, range of motion, and strength. RESULTS: This protocol will provide a reliable theoretical basis for the following research. CONCLUSION: It is assumed that there will be a remarkable difference in postoperative outcomes between the intervention and control groups. TRIAL REGISTRATION NUMBER: 10.17605/OSF.IO/PZ9ES.