The synergistic effects of applying low-level laser therapy plus ultrasound on pain and muscle function in patients with knee osteoarthritis: A protocol of a randomized double-blind study

BACKGROUND: To our knowledge, only 1 study with limited sample size tried to evaluate the synergistic effects of ultrasound and low-level laser therapy (LLLT) in patients with knee osteoarthritis. Further research is needed to confirm this synergy with larger numbers and better design. Therefore, we will conduct this present randomized double-blind study to evaluate the synergistic effects of simultaneously applying ultrasound plus LLLT on pain and muscle function in patients with knee osteoarthritis. METHODS: The study protocol is a randomized, controlled, double-blind design. The study will be conducted at our academic hospital from February 2021 to January 2022. The study protocol was approved through Institutional Review Board in the Hunan Provincial People's Hospital. Patients will be assigned at random to the ultrasound + LLLT group, LLLT group, or the ultrasound group. 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 primary outcome is weekly change in pain intensity relative to baseline through 6 weeks of therapy. 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: This study protocol was registered in Research Registry (researchregistry6470).