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.
Background: In the past few decades, the number of surgery of anterior cruciate ligament reconstruction (ACLR) implemented in the outpatient centers has dramatically enhanced. There is still a lack of effective randomized controlled trials in the literature to demonstrate the effectiveness of tourniquets. As a kind of prospective clinical trial, this research protocol is conducted to compare the results of ACLR with and without the use of a tourniquet. Methods: All the patients aged 18 or over who underwent the selective primary anterior cruciate ligament reconstruction in our hospital from November 2020 to January 2022 are eligible to take part in our experiment. Exclusion criteria are history of peripheral neuropathy, pregnancy, lumbar radiculopathy, or surgery to the injured or contralateral knee. After the written informed consent is given, the patients participating in the study are randomly assigned to the tourniquet group (group 1) and the tourniquet free group (group 2) on the day of operation, through utilizing the computer-generated random table with 10 members in each group. And the assignments were kept in an opaque and sealed envelope. Any comments on visual difficulties in the process of operative time, arthroscopy, complications, and total bleeding from suction and drainage, as well as the reduction of postoperative hemoglobin are assessed as the parameters. The software of SPSS v. 24 is applied for all the statistical analyses. Results: This protocol will provide a reliable theoretical basis for the following research. Trial registration: This study protocol was registered in Research Registry (researchregistry6240).
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